Antibiotic strategies for eradicating Pseudomonas aeruginosa in people with cystic fibrosis

Cochrane Database of Systematic Reviews

Volumn 2014, Issue 11, 2014, Pages

  Langton Hewer, Simon C ^a   Smyth, Alan R ^b  

^a BRISTOL ROYAL HOSPITAL FOR CHILDREN   (United Kingdom)

^b UNIVERSITY OF NOTTINGHAM   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIBIOTIC AGENT; CIPROFLOXACIN; COLISTIN; TOBRAMYCIN; ANTIINFECTIVE AGENT;

ALLERGIC REACTION; ANTIBIOTIC THERAPY; BACTERIAL CLEARANCE; BACTERIUM ISOLATION; BODY MASS; CLINICAL FEATURE; COMPARATIVE STUDY; COST EFFECTIVENESS ANALYSIS; COUGHING; CYSTIC FIBROSIS; DISEASE EXACERBATION; DRUG USE; DYSPHONIA; FORCED EXPIRATORY VOLUME; FORCED VITAL CAPACITY; GENETIC SCREENING; HEARING IMPAIRMENT; HUMAN; INFECTION; KIDNEY FAILURE; LENGTH OF STAY; LUNG FUNCTION; MORTALITY RATE; NUTRITIONAL STATUS; ONSET AGE; PHOTOSENSITIVITY; PRIORITY JOURNAL; PSEUDOMONAS INFECTION; QUALITY OF LIFE ASSESSMENT; RESPIRATORY TRACT INFECTION; REVIEW; SPIROMETRY; SPUTUM CULTURE; SYSTEMATIC REVIEW; TREATMENT DURATION; VOMITING; WHEEZING; ADULT; CHILD; COMPLICATION; INHALATIONAL DRUG ADMINISTRATION; META ANALYSIS; MICROBIOLOGY; ORAL DRUG ADMINISTRATION; PSEUDOMONAS AERUGINOSA; PSEUDOMONAS INFECTIONS; RANDOMIZED CONTROLLED TRIAL (TOPIC);

ADMINISTRATION, INHALATION; ADMINISTRATION, ORAL; ADULT; ANTI-BACTERIAL AGENTS; CHILD; CIPROFLOXACIN; COLISTIN; CYSTIC FIBROSIS; HUMANS; PSEUDOMONAS AERUGINOSA; PSEUDOMONAS INFECTIONS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TOBRAMYCIN;

EID: 84922237712     PISSN: None     EISSN: 1469493X     Source Type: Journal    
DOI: 10.1002/14651858.CD004197.pub4     Document Type: Review

References (213)

1. Gibson RL, Emerson J, McNamara S, Burns JL, Rosenfeld M, Yunker A, et al.A randomized, controlled trial of inhaled tobramycin in young children with cystic fibrosis: Eradication of pseudomonas from the lower airway [abstract]. Pediatric Pulmonology 2002;Suppl 24:300. [CFGD Register: PI151c].
2. Gibson RL, Emerson J, McNamara S, Burns JL, Rosenfeld M, Yunker A, et al.Online Supplement to 'Significant microbiological effect of inhaled tobramycin in young children with cystic fibrosis'. [online]. American Journal of Respiratory and Critical Care Medicine 2003;167(6):841 Online. [CFGD Register: PI151e].
3. Gibson RL, Emerson J, McNamara S, Burns JL, Rosenfeld M, Yunker A, et al.Significant microbiological effect of inhaled tobramycin in young children with cystic fibrosis. American Journal of Respiratory and Critical Care Medicine 2003;167(6):841-9. [CFGD Register: PI151d].
4. Rosenfeld M. Serum and lower respiratory tract tobramycin concentrations produced by inhaled tobramycin (TOBI) in young children with cystic fibrosis [abstract]. Pediatric Pulmonology 1999;Suppl 19:106-8. [CFGD Register: PI151b].
5. Rosenfeld M, Borowitz D, Emerson J, Gibson R, McCoy K, McNamara S, et al.Serum pharmacokinetics and safety of inhaled tobramycin in very young CF patients [abstract]. Pediatric Pulmonology 1999;Suppl 19:262. [CFGD Register: PI151a].
6. Proesmans M, Boulanger L, Vermeulen F, De Boeck K. Eradication of recent Pseudomonas aeruginosa isolation: TOBI versus colistin/ciprofloxacin [abstract]. Journal of Cystic Fibrosis 2008;7(S2):S64. [CFGD Register: PI208a].
7. Proesmans M, Boulanger L, Vermeulen F, De Boeck K. Eradication of recent Pseudomonas aeruginosa isolation: TOBI versus colistin/ciprofloxacin [abstract]. Pediatric Pulmonology 2009;44(S32):321, Abstract no: 311. [CFGD Register: PI208b; MEDLINE: 96296083].
8. Proesmans M, Boulanger L, Vermeulen F, De Boeck K. Eradication of recent pseudomonas aeruginosa infection: TOBI versus Colistineb®/ ciprofloxacin [abstract]. Journal of Cystic Fibrosis 2011;10 Suppl 1:S26, Abstract no: 102. [CFGD Register: PI208c].
9. Proesmans M, Vermeulen F, Boulanger L, Verhaegen J, De Boeck K. Comparison of two treatment regimens for eradication of Pseudomonas aeruginosa infection in children with cystic fibrosis. Journal of Cystic Fibrosis 2013;12(1):29-34. [CFGD Register: PI208d].
10. Ratjen F, Munck A, Campello V. Inhaled tobramycin nebuliser solution for treatment of early Pseudomonas aeruginosa infection: first results from the Elite study [abstract]. Pediatric Pulmonlogy 2006;41(S29):318. [CFGD Register: PI197b].
11. Ratjen F, Munck A, Campello V. Safety of inhaled tobramycin nebuliser solution for treatment of early pseudomonas aeruginosa infection: first results from the ELITE study [abstract]. Journal of Cystic Fibrosis 2006;5 Suppl 1:S22. [CFGD Register: PI197a].
12. Ratjen F, Munck A, Kho P. Short and long-term efficacy of inhaled tobramycin in early P. Aeruginosa infection: the ELITE study [abstract]. Pediatric Pulmonology 2008;43(S31):319. [CFGD Register: PI197d].
13. Ratjen F, Munck A, Kho P, Angyalosi G, for the ELITE Study Group. Treatment of early Pseudomonas aeruginosa infection in patients with cystic fibrosis: the ELITE trial. Thorax 2010;65(4):286-91. [CFGD Register: PI197e].
14. Ratjen F, Stenglein S, Munck A. Inhaled tobramycin nebulizer solution for treatment of early Pseudomonas aeruginosa infection; the ELITE study [abstract]. Journal of Cystic Fibrosis 2008;7 Suppl 2:S26. [CFGD Register: PI197c].
15. Cariani L, Defilippi G, Costantini D, Claut L, Clarizia G, D'accico M, et al.Semi-automated rep-pcr genotyping of pseudomonas aeruginosa in Italian CF patients in eradication therapy [abstract]. Pediatric Pulmonology 2010;45 Suppl 33:348, Abstract no: 360. [CFGD Register: PI230c].
16. Dolce D, Cariani L, Ravenni N, Mergni G, Biffi A, Colombo C, et al.Anti-P.aeruginosa antibodies and microbiological outcome in patients treated with early eradication therapy [abstract]. Pediatric Pulmonology 2013;48 Suppl 36:288, Abstract no: 231. [CENTRAL: 921692; CFGD Register: PI230i; CRS: 5500125000000403].
17. Taccetti G, Bianchini E, Zavataro L, Campana S, Defilippi G, Ravenni N, et al.Pseudomonas aeruginosa eradication in cystic fibrosis: preliminary data from a randomized multicenter study of two different early antibiotic treatment protocols [abstract]. Pediatric Pulmonology 2010;45(S33):337, Abstract no: 332. [CFGD Register: PI230d].
18. Taccetti G, Bianchini E, Zavataro L, Campana S, Defilippi G, Ravenni N, et al.Pseudomonas aeruginosa microbiological status and emergence of other pathogens after early eradication treatment in cystic fibrosis: a post-trial follow-up [abstract]. Pediatric Pulmonology 2011;46(S34):317, Abstract no: 292. [CFGD Register: PI230e].
19. Taccetti G, Bianchini E, Zavataro L, Campana S, Ravenni N, Boni V, et al.Early antibiotic treatment for Pseudomonas aeruginosa eradication in cystic fibrosis patients: a randomized multicenter study of two different protocols [abstract]. Pediatric Pulmonology 2009;44(S32):354, Abstract no: 406. [CFGD CF Register: PI230a; MEDLINE: 96296083].
20. Taccetti G, Bianchini E, Zavataro L, Costantini D, Galici V, Campana S, et al.Pseudomonas aeruginosa eradication in cystic fibrosis: final results of a randomized multicenter study of two different early antibiotic treatment protocols [abstract]. Pediatric Pulmonology 2011;46(S34):317, Abstract no: 291. [CFGD Register: PI230f].
21. Taccetti G, Cocchi P, Dolce D, Galici V, Mergni G, Gagliardini R, et al.Is early eradication treatment against P.aeruginosa associated with the emergence of other non-fermenter gram negatives [abstract]. Pediatric Pulmonology 2013;48 Suppl 36:328, Abstract no: 338. [CENTRAL: 921671; CFGD Register: PI230h; CRS: 5500125000000398].
22. Taccetti G, Bianchini E, Cariani L, Buzzetti R, Costantini D, Trevisan F, et al.Early antibiotic treatment for Pseudomonas aeruginosa eradication in patients with cystic fibrosis: a randomised multicentre study comparing two different protocols. Thorax 2012;67(10):853-9. [CFGD Register: PI230g].
23. Zavataro L, Taccetti G, Cariani L, Ravenni N, Braccini G, Bresci S, et al.Epidemiology of first/new Pseudomonas aeruginosa infection in cystic fibrosis patients [abstract]. Journal of Cystic Fibrosis 2010;9 Suppl 1:S29, Abstract no: 110. [CFGD Register: PI230b].
24. Anstead M, Lymp J, Khan U, Barbieri J, Langkamp M, Doring G, et al.Pseudomonas aeruginosa serology predicts response to treatment and re-infection in the EPIC clinical study [abstract]. Pediatric Pulmonology 2011;46(S34):303, Abstract no: 254. [CFGD Register: PI202g].
25. Hamblett NM, Retsch-Bogart GZ, Treggiari M, Kronmal RA, Khan U, Williams J, et al.Safety and efficacy of anti-pseudomonal therapy for early eradication of Pseudomonas aeruginosa: the EPIC study [abstract]. Pediatric Pulmonology 2009;44(S32):183. [CFGD CF Register: PI202b; MEDLINE: 96296083].
26. Hoffman LR, Ramsey BW, Kulasekara HD, Retsch-Bogart GZ, Wolter DJ, Pope CE, et al.Pseudomonas aeruginosa (PA) phenotypes associated with persistent early infection in CF patients in the EPIC Clinical Trial [abstract]. Pediatric Pulmonology 2012;47(S35):317, Abstract no: 266. [CFGD Register: PI202j].
27. Khan U, Mayer-Hamblett N, Retsch-Bogart G, Treggiari M, Ramsey B. Association between baseline pseudomonas aeruginosa positivity in EPIC clinical trial participants & prior antibiotic exposure [abstract]. Pediatric Pulmonology 2010;45(S33):335, Abstract no: 326. [CFGD Register: PI202f].
28. Mayer-Hamblett N, Kronmal RA, Gibson RL, Rosenfeld M, Retsch-Bogart G, Treggiari MM, et al.Initial Pseudomonas aeruginosa treatment failure is associated with exacerbations in cystic fibrosis. Pediatric Pulmonology 2012;47(2):125-34. [CFGD Register: PI202i; DOI: 10.1002/ppul.21525].
29. Mayer-Hamblett N, Rosenfeld M, Treggiari MM, Konstan MW, Retsch-Bogart G, Morgan W, et al.Standard care versus protocol based therapy for new onset Pseudomonas aeruginosa in cystic fibrosis. Pediatric Pulmonology 2013;48(10):943-53. [CENTRAL: 916577; CFGD Register: PI202k; CRS: 5500125000000727; PUBMED: 23818295].
30. Ramsey B. TOBI use in infants and children with early Pseudomonas Aeruginosa infection - duration of effect and epic update [abstract]. Pediatric Pulmonology 2005;40(S28):146. [CFGD CF Register: PI202a].
31. Treggiari M, Retsch-Bogart G, Mayer-Hamblett N, Khan U, Kronmal R, Ramsey B, et al.Comparative efficacy and safety of four randomized regimens to treat early Pseudomonas aeruginosa infection in children with cystic fibrosis [abstract]. Journal of Cystic Fibrosis 2010;9 Suppl 1:S54, Abstract no: 209. [CFGD Register: PI202e].
32. Treggiari M, Retsch-Bogart GZ, Mayer-Hamblett N, Kronmal R, Khan U, Williams J, et al.Early anti-pseudomonal infection in children with CF: study population and conduct of the "EPIC" clinical trial [abstract]. Pediatric Pulmonology 2009;44(S32):316, Abstract no: 299. [CFGD CF Register: PI202c; MEDLINE: 96296083].
33. Treggiari MM, Retsch-Bogart G, Mayer-Hamblett N, Khan U, Kulich M, Kronmal R, et al.Comparative efficacy and safety of 4 randomized regimens to treat early Pseudomonas aeruginosa infection in children with cystic fibrosis. Archives of Pediatrics and Adolescent Medicine 2011;165(9):847-56. [CFGD Register: PI202h].
34. Treggiari MM, Rosenfeld M, Mayer-Hamblett N, Retsch-Bogart G, Gibson RL, Williams J, et al.Early anti-pseudomonal acquisition in young patients with cystic fibrosis: rationale and design of the EPIC clinical trial and observational study. Contempory Clinical Trials 2009;30(3):256-68. [CFGD CF Register: PI202d; MEDLINE: 96296083].
35. Valerius NH, Koch C, Høiby N. Prevention of chronic Pseudomonas aeruginosa colonisation in cystic fibrosis by early treatment. Lancet 1991;338(8769):725-6. [CFGD Register: PI70b].
36. Valerius NH, Koch C, Høiby N. Prevention of chronic colonization with Pseudomonas aeruginosa in patients with CF by early treatment with ciprofloxacin and colistin aerosol inhalations [abstract]. Pediatric Pulmonology 1990;9(Supplement S5):248. [CFGD Register: PI70a].
37. Ratjen F, Steinkamp G, Döring G, Bauernfeind A, Wiesemann HG, Von Der Hardt H. Prevention of chronic pseudomonas aeruginosa infection by early inhalation therapy with tobramycin [abstract]. Pediatric Pulmonology 1994;Suppl 10:250. [CFGD Register: PI101a].
38. Wiesemann HG, Steinkamp G, Ratjen F, Baurnfeind A, Przyklenk B, Döring G, et al.Placebo-controlled, double-blind, randomised study of aerosolised tobramycin for early treatment of Pseudomonas aeruginosa colonization in cystic fibrosis. Pediatric Pulmonology 1998;25(2):88-92. [CFGD Register: PI101b].
39. Alothman GA, Alsaadi MM, Ho BL, Ho SL, Dupuis A, Corey M, et al.Evaluation of bronchial constriction in children with cystic fibrosis after inhaling two different preparations of tobramycin. Chest 2002;122(3):930-4. [CENTRAL: 398028; CFGD Register: PI157b; CRS: 5500100000002196; PUBMED: 12226034].
40. Alothman GA, Coates AL, Corey M, Dupuis A, Ho SL, Ho BL, et al.In cystic fibrosis (CF) patients, does the inhalation of an intravenous tobramycin preparation result in more bronchospasm than a preservative free tobramycin preparation? [abstract]. Pediatric Pulmonology 2000;Suppl 20:298-9. [CFGD Register: PI157a].
41. Alothman GA, Ho B, Alsaadi MM, Ho SL, O'Drowsky L, Louca E, et al.Bronchial constriction and inhaled colistin in cystic fibrosis. Chest 2005;127(2):522-9. [CENTRAL: 502709; CFGD Register: PI190; CRS: 5500100000002670; PUBMED: 15705991].
42. Ballman M, Rabsch P, von der Hardt H. Long term follow up of changes in FEV1 and treatment intensity during Pseudomonas aeruginosa colonisation in patients with cystic fibrosis. Thorax 1998;53(9):732-7.
43. Brett MM, Simmonds EJ, Ghonheim ATM, Littlewood JM. The value of serum IgG titres against Pseudomonas aeruginosa in the management of early infection in cystic fibrosis. Archives of Disease in Childhood 1992;67(9):1086-8. [CFGD Register: PI73].
44. Church DA, Kanga JF, Kuhn RJ, Rubio TT, Spohn WA, Stevens JC, et al.Sequential ciprofloxacin therapy in pediatric cystic fibrosis: comparative study vs. ceftazidime/tobramycin in the treatment of acute pulmonary exacerbations. The Cystic Fibrosis Study Group. Pediatric Infectious Disease Journal 1997;16(1):97-105. [CENTRAL: 135891; CFGD Register: PI115; CRS: 5500100000000803; PUBMED: 9002118].
45. Clancy JP, Dupont L, Konstan MW, Billings J, Fustik S, Goss CH, et al.Phase II studies of nebulised Arikace in CF patients with Pseudomonas aeruginosa infection. Thorax 2013;68(9):818-25. [CENTRAL: 876398; CFGD Register: PI207e // PI222c; CRS: 5500050000000084; PUBMED: 23749840].
46. Clancy JP, Minic P, Dupont L, Goss CH, Quittner AL, Lymp JF, et al.Full analysis of data from two phase II blinded & placebo-controlled studies of nebulized liposomal amikacin for inhalation (Arikace) in the treatment of CF patients with pseudomonas aeruginosa lung infection [abstract]. Pediatric Pulmonology 2010;45 Suppl 33:299, Abstract no: 227. [CENTRAL: 848916; CFGD Register: PI207d // PI222b; CRS: 5500100000010628].
47. Dupont L, Minic P, Fustic S, Mazurek H, Solyom E, Feketova A, et al.A randomised placebo-controlled study of nebulized liposomal amikacin (Arikace) in the treatment of cystic fibrosis patients with chronic Pseudomonas aeruginosa lung infection [abstract]. Journal of Cystic Fibrosis 2008;7 Suppl 2:S26. [CENTRAL: 790820; CFGD Register: PI207a; CRS: 5500100000003531].
48. Dupont LJ, Minic P, Fustik S, Mazurek H, Solyom E, Feketeova A, et al.A randomized placebo-controlled study of nebulized liposomal amikacin (Arikace) in the treatment of cystic fibrosis patients with chronic Pseudomonas Aeruginosa lung infection [abstract]. Pediatric Pulmonology 2008;43 Suppl 31:301. [CENTRAL: 790939; CFGD Register: PI207b; CRS: 5500100000003535].
49. Gupta R, Dupont L, Minin P, Fustik S, Mazurek H, Solyom E, et al.A randomized placebo-controlled study of nebulized liposomal amikacin (Arikace) in the treatment of cystic fibrosis patients with chronic Pseudomonas aeruginosa lung infection (protocol TR02-105) [abstract]. American Journal of Respiratory and Critical Care Medicine 2009;179:Abstract no: A1199. [CENTRAL: 790940; CFGD Register: PI207c; CRS: 5500100000003536].
50. Coates AL, Denk O, Leung K, Ribeiro N, Chan J, Green M, et al.Higher tobramycin concentration and vibrating mesh technology can shorten antibiotic treatment time in cystic fibrosis. Pediatric Pulmonology 2011;46(4):401-8. [CENTRAL: 786190; CFGD Register: PI241b; CRS: 5500100000006333].
51. Denk O, Caotes AL, Keller M, Leung K, Green M, Chan J, et al.Lung delivery of a new tobramycin nebuliser solution (150mg/1.5ml) by an investigational eFlow® nebuliser is equivalent to TOBI® but in a fraction of time [abstract]. Journal of Cystic Fibrosis 2009;8 Suppl 2:S66, Abstract no: 264. [CENTRAL: 794467; CFGD Register: PI241c; CRS: 5500100000003576].
52. Keller M, Coates AL, Griese M, Denk O, Schierholz J, Knoch M. In-vivo data support equivalent therapeutic efficacy of a new tobramycin inhalation solution (150mg/1.5ml) administered by the eFlow® electronic nebuliser compared to TOBI® in the PARI LC PLUS® [abstract]. Journal of Cystic Fibrosis 2010;9 Suppl 1:S22, Abstract no: 84. [CENTRAL: 794286; CFGD Register: PI241a; CRS: 5500100000003569].
53. Frederiksen B, Koch C, Høiby N. Antibiotic treatment of initial colonisation with Pseudomonas aeruginosa postpones chronic infection and prevents deterioration of pulmonary function in cystic fibrosis. Pediatric Pulmonology 1997;23(5):330-5.
54. Geller DE, Howenstine M, Conrad C, Smith J, Mulye S, Shrewsbury SB. A phase 1 study to assess the tolerability of a novel tobramycin powder for inhalation (TPI) formulation in cystic fibrosis subjects [abstract]. Pediatric Pulmonology 2004;38(Suppl 27):250. [CENTRAL: 507896; CFGD Register: PI187a; CRS: 5500100000002694].
55. Geller DE, Konstan MW, Smith J, Noonberg SB, Conrad C. Novel tobramycin inhalation powder in cystic fibrosis subjects: Pharmacokinetics and safety. Pediatric Pulmonology 2007;42(4):307-13. [CENTRAL: 587235; CFGD Register: PI187c; CRS: 5500100000002919; PUBMED: 17352404].
56. Rodriguez CA, Shrewsbury SB, Potter SN, Nardella P, Geller DE. Single dose pharmacokinetics of tobramycin after administration of a novel dry powder formulation (TPI) in subjects with cystic fibrosis (cf) [abstract]. Pediatric Pulmonology 2004;38 Suppl 27:250. [CENTRAL: 526254; CFGD Register: PI187b; CRS: 5500100000002754].
57. Gibson RL, Emerson J, Mayer-Hamblett N, Burns JL, McNamara S, Accurso FJ, et al.Duration of treatment effect after tobramycin solution for inhalation in young children with cystic fibrosis. Pediatric Pulmonology 2007;42(7):610-23.
58. Goss CH, Clancy JP, Nick JA, Billings J, Rubenstein RC, Young KR, et al.A phase 2 blinded and placebo-controlled study of nebulized liposomal amikacin (arikace) in the treatment of CF patients with Pseudomonas aeruginosa lung infection [abstract]. Pediatric Pulmonology 2009;44(S32):295. [CFGD CF Register: PI222].
59. Griese M, Mueller I, Reinhardt D. Eradication of initial Pseudomonas aeruginosa colonisation in patients with cystic fibrosis. European Journal of Medical Research 2002;7(2):79-80.
60. Heinzl B, Eber E, Oberwaldner B, Haas G, Zach M. Effects of inhaled gentamicin prophylaxis on acquisition of Pseudomonas aeruginosa in children with cystic fibrosis: a pilot study. Pediatric Pulmonology 2002;33(1):32-7.
61. Kenny S, Hall V, Goldsmith C, Moore J, Rendall JC, Elborn JS. Eradication of Pseudomonas aeruginosa in adults with CF [abstract]. Journal of Cystic Fibrosis 2009;8 Suppl 2:S39, Abstract no: 158. [CFGD CF Register: PI229a; MEDLINE: 96296083].
62. Kenny SL, Shaw TD, Downey DG, Moore JE, Rendall JC, Elborn JS. Eradication of Pseudomonas aeruginosa in adults with cystic fibrosis. BMJ Open Respiratory Research 2014;1:e000021.
63. Konstan MW, Geller DE, Brockhaus F, Zhang J, Angyalosi G. Tobramycin inhalation powder is effective and safe in the treatment of chronic pulmonary Pseudomonas aeruginosa (Pa) infection in patients with cystic fibrosi [abstract]. American Journal of Respiratory and Critical Care Medicine 2009;179:Abstract no: A1186. [CENTRAL: 744126; CFGD Register: PI227a; CRS: 5500100000003455].
64. Konstan MW, Geller DE, Minic P, Brockhaus F, Zhang J, Angyalosi G. Effective treatment of chronic Pseudomonas aeruginosa (Pa) infection with tobramycin inhalation powder in CF patients [abstract]. Journal of Cystic Fibrosis 2009;8 Suppl 2:S27, Abstract no: 105. [CENTRAL: 744127; CFGD Register: PI227b; CRS: 5500100000003456].
65. Konstan MW, Geller DE, Minic P, Brockhaus F, Zhang J, Angyalosi G. Tobramycin inhalation powder for P. aeruginosa infection in cystic fibrosis: The EVOLVE trial. Pediatric Pulmonology 2010;46:230-8. [CENTRAL: 867122; CFGD Register: PI227e; CRS: 5500100000011272; PUBMED: 20963831].
66. McColley S, Rietschel E, Brockhaus F, Angyalosi G, Higgins M. Safety of inhaled tobramycin in patients with cystic fibrosis [abstract]. Pediatric Pulmonology 2011;46 Suppl 34:344, Abstract no: 365. [CENTRAL: 848919; CFGD Register: PI227d // PI239h; CRS: 5500100000010634].
67. Novartis (NCT00125346). Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Subjects (EVOLVE). Http://clinicaltrials.gov/ct2/show/NCT00125346 2010. [CENTRAL: 867467; CFGD Register: PI227c; CRS: 5500100000006168].
68. Latzin P, Fehling M, Bauernfeind A, Reinhardt D, Kappler M, Griese M. Efficacy and safety of intravenous meropenem and tobramycin versus ceftazidime and tobramycin in cystic fibrosis. Journal of Cystic Fibrosis 2008;7(2):142-6. [CFGD Register: PI209].
69. Lenoir G, Antypkin YG, Miano A, Moretti P, Zanda M, Varoli G, et al.Efficacy, safety, and local pharmacokinetics of highly concentrated nebulized tobramycin in patients with cystic fibrosis colonized with Pseudomonas aeruginosa. Paediatric Drugs 2007;9 Suppl:11-20. [CFGD Register: Pi196c].
70. Lenoir G, Aryayev N, Varoli G, Monici Preti P. Aerosolized tobramycin in the treatment of patients with cystic fibrosis and pseudomonas aeruginosa infection [abstract]. Journal of Cystic Fibrosis 2006;5 Suppl 1:S42. [CFGD Register: PI196b].
71. Lenoir G, Aryayev N, Varoli G, Monici Preti P. Highly concentrated aerosolized tobramycin in the treatment of patients with cystic fibrosis and Pseudomonas aeruginosa infection [abstract]. European Respiratory Journal 2005;26 Suppl 49:620s. [CFGD Register: PI196a].
72. Littlewood JM, Miller MG, Ghoneim AT, Ramsden CH. Nebulised colomycin for early pseudomonal colonisation in cystic fibrosis [letter]. Lancet 1985;1(8433):865.
73. Mainz JG, Schadlich K, Schien C, Michl R, Schelhorn-Neise P, Koitschev A, et al.Sinonasal inhalation of tobramycin vibrating aerosol in cystic fibrosis patients with upper airway Pseudomonas aeruginosa colonization: results of a randomized, double-blind, placebo-controlled pilot study. Drug Design, Development and Therapy 2014;8:209-17. [CENTRAL: 981442; CFGD Register: PI248b; CRS: 5500125000000721; PUBMED: 24596456].
74. Mainz JG, Schien C, Schadlich K, Pfister W, Schelhorn-Neise P, Koitschev A, et al.Sinonasal inhalation of tobramycin in cystic fibrosis patients with P. aeruginosa colonization of the upper airways - results of a multicentric placebo-controlled pilot study [abstract]. Journal of Cystic Fibrosis 2011;10 Suppl 1:S21, Abstract no: 83. [CENTRAL: 848866; CFGD Register: PI248a; CRS: 5500100000010543].
75. Mazurek H, Chiron R, Pelikan L, Geidel C, Bolbas K, Antipkin Y, et al.Comparison of two inhaled tobramycin solutions in cystic fibrosis patients with chronic pseudomonas aeruginosa infection: results in different age subgroups [abstract]. Journal of Cystic Fibrosis 2011;10 Suppl 1:S28, Abstract no: 111. [CENTRAL: 848929; CFGD Register: PI249b; CRS: 5500100000010714].
76. Mazurek H, Chiron R, Varoli G, Santoro D, Cicirello H, Antipkin Y. Efficacy on lung function and safety of multiple courses of tobramycin 300mg/4 ml nebuliser solution (Bramitob) in patients with cystic fibrosis and chronic pseudomonas aeruginosa infection: results from a 48-week extension phase [abstract]. Journal of Cystic Fibrosis 2012;11 Suppl1:S74, Abstract no: 69. [CENTRAL: 867264; CFGD Register: PI249c; CRS: 5500100000011290].
77. Mazurek H, Lenoir G, Pelikan L, Geidel C, Bolbas K, Antipkin Y, et al.Head-to-head comparison of two inhaled tobramycin solutions in cystic fibrosis (CF) patients with chronic pseudomonas aeruginosa (Pa) infection [abstract]. Journal of Cystic Fibrosis 2011;10 Suppl 1:S28, Abstract no: 110. [CENTRAL: 848928; CFGD Register: PI249a; CRS: 5500100000010713].
78. Oermann CM, McCoy KS, Retsch-Bogart GZ, Gibson R, McKevitt M, Montgomery B. Antibiotic susceptibility in Pseudomonas Aeruginosa (PA) isolates following exposure to aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis [abstract]. Pediatric Pulmonology 2009;44(S32):309, Abstract no: 278. [CFGD CF Register: PI220a].
79. Oermann CM, McCoy KS, Retsch-Bogart GZ, Gibson R, McKevitt M, Montgomery B. Effect of repeated exposure to aztreonam for inhalation solution (AZLI) therapy on cystic fibrosis respiratory pathogens [abstract]. Pediatric Pulmonology 2009;44(Suppl 32):335, Abstract no: 353. [CFGD Register: PI220d].
80. Oermann CM, McCoy KS, Retsch-Bogart GZ, Gibson RL, Montgomery AB. Effect of multiple courses of Aztreonam Lysine for inhalation (AZLI) on FEV1 and weight in patients with cystic fibrosis (CF) and Pseudomonas aeruginosa (PA): analysis of 18 month data from CP-AI-006 [abstract]. Journal of Cystic Fibrosis 2009;8 Suppl 2:S28, Abstract no: 107. [CFGD CF Register: PI220c].
81. Oermann CM, McCoy KS, Retsch-Bogart GZ, Gibson RL, Quittner AL, Montgomery AB. Adherence over multiple courses of Aztreonam for inhalation (AZLI): effect on disease- related endpoints in patients with cystic fibrosis (CF) and Pseudomonas aeruginosa (PA) [abstract]. Journal of Cystic Fibrosis 2009;8 Suppl 2:S28, Abstract no: 109. [CFGD CF Register: PI220b].
82. Oermann CM, Retsch-Bogart GZ, Quittner AL, Gibson RL, McCoy KS, Montgomery AB, et al.An 18-month study of the safety and efficacy of repeated courses of inhaled aztreonam lysine in cystic fibrosis. Pediatric Pulmonology 2010;45(11):1121-34. [CFGD Register: PI220e].
83. Quitnner AL, Henig NR, Lewis S, Derchak PA, McCoy KS, Oermann CM, et al.Effects of chronic intermittant aztreonam for inhalation solution (AZLI) on health-related quality of life (HRQOL) in persons with cystic fibrosis (CF) and P. aeruginosa [abstract]. Pediatric Pulmonology 2011;46 Suppl 34:299, Abstract no: 240. [CENTRAL: 867260; CFGD Register: PI220f/PI213j; CRS: 5500100000011261].
84. Postnikov SS, Semykin SYU, Kapranov NI, Perederko LV, Polikarpova SV, Khamidullina KF. Evaluation of pefloxacin efficacy and tolerability in the treatment and prophylaxis of severe infections at the children with mucoviscidosis and aplastic anaemia. Antibiotiki i Khimioterapiia 2000;45(8):25-30. [CFGD Register: PI171].
85. Postnikov SS, Semykin SY, Polikarpova SV, Dubovik LG, Gracheva LA, Sagatelyan. A prospective trial on the efficacy and tolerability of twice-daily dosing (TDD) versus once-daily dosing (ODD) amikacin in cystic fibrosis patients [abstract]. Journal of Cystic Fibrosis 2007;6 Suppl 1:S34. [CFGD CF Register: PI204].
86. Prayle A, Jain K, Watson A, Smyth AR. Are morning doses of intravenous tobramycin less nephrotoxic than evening? Evidence from urinary biomarkers in the critic study [abstract]. Pediatric Pulmonology 2013;48 Suppl 36:299, Abstract no: 261. [CENTRAL: 980338; CFGD Register: CO55; CRS: 5500125000000420].
87. Birnbaum HG, Greenberg P, Finkelstein S, Berndt E, Otto KL, Montgomery AB, et al.Economic analysis of hospitalization and home IV anti-pseudomonal antibiotic use in CF patients on tobramycin solution for inhalation (TOBI®) [abstract]. Pediatric Pulmonology 1998;Suppl 17:273. [CENTRAL: 792738; CRS: 5500100000003553].
88. Bowman CM. The long-term use of inhaled tobramycin in patients with cystic fibrosis. Journal of Cystic Fibrosis 2002;1 Suppl 2:S194-8. [CENTRAL: 451888; CFGD Register: PI120cc; CRS: 5500100000002389].
89. Burns JL, Van Dalfsen JM, Shawar RM, Otto KL, Garber RL, Quan JM, et al.Effect of chronic intermittent administration of inhaled tobramycin on respiratory microbial flora in patients with cystic fibrosis. Journal of Infectious Diseases 1999;179(5):1190-6. [CENTRAL: 161606; CRS: 5500100000000895; PUBMED: 10191222].
90. Casey S, Ramsey B, Borowitz D. Nutritional benefits of chronic intermittent Pseudomonas aeruginosa suppression with tobramycin solution for inhalation in adolescents [abstract]. 13th International Cystic Fibrosis Congress; 2000 June 4-8; Stockholm, Sweden. 2000:172. [CENTRAL: 302945; CRS: 5500100000001685].
91. Enger C, Rothman K, Kylstra JW. Mortality rates during 2 years of treatment with intermittent inhaled tobramycin (TOBI) in CF [abstract]. Pediatric Pulmonology 1999;Suppl 19:339-40. [CENTRAL: 291292; CRS: 5500100000001353].
92. Fiel SB. Long term effect of tobramycin solution for inhalation on reduction of hospitalization of CF patients [abstract]. European Respiratory Journal 2000;16(Suppl 31):1545. [CENTRAL: 415647; CRS: 5500100000002265].
93. Fiel SB. Long term effect of tobramycin solution for inhalation on reduction of hospitalization of CF patients [abstract]. European Respiratory Journal 2000;16(Suppl 31):1545. [CENTRAL: 415647; CFGD Register: PI120dd; CRS: 5500100000002265].
94. Geller DE, Pitlick WH, Nardella PA, Tracewell WG, Ramsey BW. Pharmacokinetics and bioavailability of aerosolized tobramycin in cystic fibrosis. Chest 2002;122(1):219-26. [CFGD Register: PI120bb; CENTRAL: 404033; CRS: 5500100000002214].
95. Graff GR, Gordon DC, Van Dalfsen JM, Burns JL. Epidemiology of Stenotrophomonas maltophilia culture in cystic fibrosis (CF) patients during the tobramycin solution for inhalation (TOBI®) study [abstract]. Pediatric Pulmonology 2000;Suppl 20:283. [CENTRAL: 793580; CRS: 5500100000003564].
96. Hazinski TA. Intermittent administration of inhaled tobramycin in patients with cystic fibrosis. Journal of Pediatrics 1999;135(1):130. [CENTRAL: 165714; CRS: 5500100000000909; EMBASE: 1999019576; PUBMED: 10428654].
97. Konstan MW, VanDevanter DR. Peripheral white blood cell count as a surrogate marker for progression of lung disease in cystic fibrosis [abstract]. Pediatric Pulmonology 2001;Suppl 22:305. [CENTRAL: 362193; CRS: 5500100000001991].
98. Kylstra JW, Bowman CM, Meyer U, Montgomery AB, Schaeffler B, Stewart P, et al.Who benefits more? An age-stratified analysis of lung function and weight gain in CF patients using inhaled tobramycin [abstract]. Netherlands Journal of Medicine 1999;54(Suppl):S83. [CENTRAL: 291415; CRS: 5500100000001449].
99. LeLorier J, Perreault S, Birnbaum H, Greenberg P, Sheehy O. Savings in direct medical costs from the use of tobramycin solution for inhalation in patients with cystic fibrosis. Clinical Therapeutics 2000;22(1):140-51. [CENTRAL: 275378; CRS: 5500100000001232; PUBMED: 10688397].
100. LiPuma JJ. Microbiological and immunologic considerations with aerosolized drug delivery. Chest 2001;120(3 Suppl):118S-23S. [CENTRAL: 356379; CRS: 5500100000001971; PUBMED: 11555566].
101. MacLeod DL, Nelson LE, Shawar RM, Lin BB, Lockwood LG, Dirk JE, et al.Aminoglycoside-resistance mechanisms for cystic fibrosis Pseudomonas aeruginosa isolates are unchanged by long-term, intermittent, inhaled tobramycin treatment. Journal of Infectious Diseases 2000;181(3):1180-4. [CENTRAL: 302968; CRS: 5500100000001702].
102. Moss R, Kylstra JW, Montgomery AB, Gibson R. Who benefits more? An analysis of FEV1 and weight in adolescent (age 13-<18) CF patients using inhaled tobramycin (TOBI) [abstract]. Pediatric Pulmonology 1999;Suppl 19:243. [CENTRAL: 291469; CRS: 5500100000001497].
103. Moss RB. Administration of aerosolized antibiotics in cystic fibrosis patients. Chest 2001;120(3 Suppl):107S-13S. [CENTRAL: 368291; CRS: 5500100000002023].
104. Moss RB. Long-term benefits of inhaled tobramycin in adolescent patients with cystic fibrosis. Chest 2002;121(1):55-63. [CENTRAL: 377132; CRS: 5500100000002049; PUBMED: 11796432].
105. Nickerson B, Montgomery AB, Kylstra JW, Ramsey BW. Safety and effectiveness of 2 years of treatment with intermittent inhaled tobramycin in CF patients [abstract]. Pediatric Pulmonology 1999;Suppl 19:243-4. [CENTRAL: 291479; CRS: 5500100000001506].
106. Otto KL, Montgomery AB, Lin A, Ramsey BW. Seasonality of hospitalization for pulmonary exacerbations and lower respiratory tract infections in Phase III tobramycin solution for inhalation (TOBI®) trials [abstract]. Pediatric Pulmonology 1998;Suppl 17:273. [CENTRAL: 795752; CRS: 5500100000003601].
107. Quan JM, Vasiljev M, Schaeffler B, Phelps C, Burrington C, Meyer U. Treatment for exacerbation only does not arrest progressive lung function decline in CF [abstract]. Netherlands Journal of Medicine 1999;54(Suppl):S84. [CENTRAL: 291523; CRS: 5500100000001545].
108. Quittner A, Gordon D, Yu X. Convergence of quality of life assessments and clinical outcomes in patients enrolled in the tobramycin solution for inhalation (TSI) trials [abstract]. 24th European Cystic Fibrosis Conference; 2001 June 6-9; Vienna, Austria. 2001:P326. [CENTRAL: 614345; CRS: 5500100000003153].
109. Quittner AL, Buu A. Effects of tobramycin solution for inhalation on global ratings of quality of life in patients with cystic fibrosis and Pseudomonas aeruginosa infection. Pediatric Pulmonology 2002;33(4):269-76. [CENTRAL: 379174; CRS: 5500100000002059; PUBMED: 11921456].
110. Quittner AL, Buu A, Gordon D. Longitudinal changes in global ratings of quality of life for patients in the tobramycin solution for inhalation (TSI) trials [abstract]. Pediatric Pulmonology 2001;Suppl 22:349. [CENTRAL: 362214; CRS: 5500100000002002].
111. Ramsey B, Burns J, Smith A. Safety and efficacy of Tobramycin Solution for Inhalation in patients with cystic fibrosis: The results of two phase III placebo controlled clinical trials [abstract]. Pediatric Pulmonology 1997;Suppl 14:137-8. [CENTRAL: 385760; CRS: 5500100000002121].
112. Ramsey BW, Bowman MC, Montgomery AB, Smith AR, TOBIStudy G. Design of phase 3 aerosolized tobramycin studies for chronic intermittent therapy [abstract]. 21st European Cystic Fibrosis Conference; 1997 June 1-6; Davos, Switzerland. 1997:144. [CENTRAL: 291527; CRS: 5500100000001548].
113. Ramsey BW, Bowman MC, Vasiljev KM, Smith AR, TOBIStudy G. Results of phase 3 aerosolized tobramycin studies for chronic intermittent therapy [abstract]. 21st European Cystic Fibrosis Conference; 1997 June 1-6; Davos, Switzerland. 1997:144. [CENTRAL: 291528; CRS: 5500100000001549].
114. Ramsey BW, Pepe MS, Quan JM, Otto KL, Montgomery AB, Williams Warren J, et al.Intermittent administration of inhaled tobramycin in patients with cystic fibrosis. cystic fibrosis Inhaled Tobramycin Study Group. New England Journal of Medicine 1999;340(1):23-30. [CENTRAL: 158508; CRS: 5500100000000883; PUBMED: 9878641].
115. Rosenfeld M, Emerson J, Williams-Warren J, Pepe M, Smith A, Montgomery AB, et al.Defining a pulmonary exacerbation in cystic fibrosis. Journal of Pediatrics 2001;139(3):359-65. [CENTRAL: 384105; CRS: 5500100000002077; PUBMED: 11562614].
116. Taylor CJ. Nebulised high dose Tobramycin (TOBI) in adolescents with cystic fibrosis [abstract]. Pediatric Pulmonology 2001;Suppl 22:291. [CENTRAL: 362226; CRS: 5500100000002008].
117. VanDevanter D, Hou K, Yu X. Effect of tobramycin solution for inhalation (TOBI®) on long term rates of lung function decline in Pseudomonas aeruginosa infected cystic fibrosis (CF) patients with mild to moderate lung disease [abstract]. Pediatric Pulmonology 2000;Suppl 20:298. [CENTRAL: 793150; CRS: 5500100000003557].
118. VanDevanter D, Yu X, Konstan MW. Effect of tobramycin solution for inhalation on circulating white blood cell counts in exacerbating and stable CF patients [abstract]. 24th European Cystic Fibrosis Conference; 2001 June 6-9; Vienna, Austria. 2001:P172. [CENTRAL: 354463; CRS: 5500100000001964].
119. Ratjen F, Döring G, Nikolaizik WH. Effect of inhaled tobramycin on early Pseudomonas aeruginosa colonisation in patients with cystic fibrosis. Lancet 2001;358(9286):983-4.
120. Burns JL, Stapp J, Lofland D, AIPhase 2SG. Microbiology results from a phase 2 clinical study of aztreonam lysinate for inhalation (AI): a new inhaled antibiotic to treat CF patients with Pseudomonas aeruginosa (PA) [abstract]. Journal of Cystic Fibrosis 2005;4 Suppl:S55. [CENTRAL: 548338; CFGD Register: PI211a; CRS: 5500100000002786].
121. Retsch-Bogart GZ, Burns JL, Otto KL, Liou TG, McCoy K, Oermann C, et al.A phase 2 study of aztreonam lysine for inhalation to treat patients with cystic fibrosis and Pseudomonas aeruginosa infection. Pediatric Pulmonology 2008;43(1):47-58. [CENTRAL: 628521; CFGD Register: PI211c; CRS: 5500100000003193; PUBMED: 18041081].
122. Retsch-Bogart GZ, Gibson RL, AIPhase 2SG. A phase 2 study of aztreonam lysinate for inhalation to treat cystic fibrosis patients with Pseudomonas aeruginosa infection [abstract]. American Thoracic Society International Conference; 2005 May 20-25; San Diego, USA. 2005:A576. [CENTRAL: 592963; CFGD Register: PI211b; CRS: 5500100000002930].
123. Retsch-Bogart GZ, McCoy KS, Gibson RL, Oermann CM. Sustained improvement in pulmonary function following a 28-day course of 75mg azli tid therapy [abstract]. Pediatric Pulmonology 2008;43 Suppl 31:320. [CENTRAL: 675920; CFGD Register: PI211d // PI213b; CRS: 5500100000003286].
124. McCoy K, Retsch-Bogart G, Gibson RL, Oermann C, Braff M, Montgomery AB. Investigation of susceptibility breakpoints for inhaled antibiotic therapies in cystic fibrosis [abstract]. Pediatric Pulmonology 2010;45 Suppl 33:341, Abstract no: 340. [CENTRAL: 848913; CFGD Register: PI212g // PI213i; CRS: 5500100000010623].
125. McCoy KS, Retsch-Boagrt GZ, Gibson RL, Oermann CM, McKevitt M, Montgomery AB. Efficacy of Aztreonam Lysine for inhalation (AZLI) in patients with cystic fibrosis and drug resistant P. aeruginosa (DRPA) [abstract]. Journal of Cystic Fibrosis 2009;8 Suppl 2:S28. [CENTRAL: 744120; CFGD Register: PI212e // PI213e; CRS: 5500100000003449].
126. McCoy KS, Retsch-Bogart GZ, Gibson R, Oermann C, Braff MH, Montgomery AB. Relevance of established susceptibility breakpoints to clinical efficacy of inhaled antibiotic therapies in cystic fibrosis [abstract]. Pediatric Pulmonology 2008;43 Suppl 31:351. [CENTRAL: 677646; CFGD Register: PI212b // PI213c; CRS: 5500100000003289].
127. Plosker GL. Aztreonam lysine for inhalation solution: in cystic fibrosis. Drugs 2010;70(14):1843-55. [CENTRAL: 848912; CFGD Register: PI212f // PI213h; CRS: 5500100000010622].
128. Quittner AL, Henig NR, Lewis S, Derchak PA, McCoy KS, Oermann CM, et al.Effects of chronic intermittent aztreonam for inhalation solution (AZLI) on health-related quality of life (HRQOL) in persons with cystic fibrosis (CF) and P. aeruginosa [abstract]. Pediatric Pulmonology 2011;46 Suppl 34:299, Abstract no: 240. [CENTRAL: 867260; CFGD Register: PI213j // PI220f; CRS: 5500100000011261].
129. Quittner AL, Retsch-Bogart GZ, McCoy KS, Oermann CM, Gibson R, Lewis S, et al.Effect of a 28-day course of aztreonam for inhalation solution (AZLI) on responses to individual CFQ-R respiratory symptoms score questions among patients with CF [abstract]. Pediatric Pulmonology 2009;44 Suppl 32:305, Abstract no: 266. [CENTRAL: 744128; CFGD Register: PI213f; CRS: 5500100000003457].
130. Retsch-Bogart GZ, McCoy KS, Gibson RL, Oermann C, Montgomery AB. Source of improvements in lung function in patients with cystic fibrosis (CF) following treatment with aztreonam lysine for inhalation (AZLI) [abstract]. Pediatric Pulmonology 2008;43 Suppl 31:320. [CENTRAL: 744116; CFGD Register: PI213d; CRS: 5500100000003445].
131. Retsch-Bogart GZ, McCoy KS, Gibson RL, Oermann CM. Sustained improvement in pulmonary function following a 28-day course of 75mg azli tid therapy [abstract]. Pediatric Pulmonology 2008;43 Suppl 31:320. [CENTRAL: 675920; CFGD Register: PI211d // PI213b; CRS: 5500100000003286].
132. Retsch-Bogart GZ, Montgomery B, Gibson R, McCoy K, Oermann CM, Cooper P. Phase 3 trial (AIR-CF 1) measuring improvement in respiratory symptoms in patients with cystic fibrosis (CF) following treatment with aztreonam lysine for inhalation [abstract]. Pediatric Pulmonology 2007;42 Suppl 30:310. [CENTRAL: 623759; CFGD Register: PI213a; CRS: 5500100000003182].
133. Retsch-Bogart GZ, Quittner AL, Gibson RL, Oermann CM, McCoy KS, Montgomery AB, et al.Efficacy and safety of inhaled aztreonam lysine for airway pseudomonas in cystic fibrosis. Chest 2009;135(5):1223-32. [CENTRAL: 698536; CFGD Register: PI213g; CRS: 5500100000010621].
134. Rietschel E, Posselt HG, Heuer HE, Merkel N, Staab D. Pharmacokinetics of tobramycin (TOBI) after 4 and 8 weeks of continuous once daily or twice daily inhalation [abstract]. Journal of Cystic Fibrosis 2009;8 Suppl 2:S27, Abstract no: 106. [CENTRAL: 795021; CFGD Register: PI232a; CRS: 5500100000003587].
135. Rietschel E, Staab D, Merkel N, van Konigsbruggen S, Posselt H. Pharmacokinetics of continuous treatment with O.D. or B.I.D inhalation of tobramycin (TOBI™) via Pari Eflow™ Rapid [abstract]. Pediatric Pulmonology 2010;45 Suppl 33:320, Abstract no: 283. [CENTRAL: 849031; CFGD Register: PI232c; CRS: 5500100000010629].
136. Rietschel E, Staab D, von Konigsbruggen S, Merkel N, Heuer HE, Posselt HG. Pharmacokinetics of continuous treatment with o.d. or b.i.d. inhalation of tobramycin (TOBITM) [abstract]. Journal of Cystic Fibrosis 2010;9 Suppl 1:S23, Abstract 106. [CENTRAL: 795018; CFGD Register: PI232b; CRS: 5500100000003586].
137. Schaad UB, Wedgwood J, Ruedeberg A, Kraemer R, Hampel B. Ciprofloxacin as antipseudomonal treatment in patients with cystic fibrosis. Pediatric Infectious Diseases Journal 1997;16(1):106-11. [CFGD Register: PI116].
138. Schelstraete P, Deschaght P, Van Daele S, Haerynck F, Van Simaey L. Genotype based evaluation of eradication treatment of new P. aeruginosa infections in CF patients [abstract]. Journal of Cystic Fibrosis 2009;8 Suppl 2:S39, Abstract no: 156. [CFGD CF Register: PI228; MEDLINE: 96296083].
139. Schelstraete P, Deschaght P, Van Simaey L, Van Daele S, Haerynck F, Vaneechoutte M, et al.Genotype based evaluation of Pseudomonas aeruginosa eradication treatment success in cystic fibrosis patients. Journal of Cystic Fibrosis 2010;9(2):99-103. [CFGD Register: PI228].
140. Goldman M, Schuster A, Halliburn C, Döring G, The FSG. A randomised, open label phase 3 study to evaluate the efficacy and safety of a dry powder formulation of inhaled colistimethate sodium (Colobreathe®) versus tobramycin nebuliser solution (TNS) in cystic fibrosis subjects with chronic Pseudomonas aeruginosa lung infection [abstract]. Journal of Cystic Fibrosis 2012;11, Suppl 1:S12, Abstract no: WS5.5. [CENTRAL: 848917; CFGD Register: PI214b; CRS: 5500100000010630].
141. Goldman MH, Pitt T. Lack of emergence of antimicrobial resistance of Pseudomonas Aeruginosa after six months inhalation of dry powder colistimethate [abstract]. Pediatric Pulmonology 2008;43 Suppl 31:331. [CFGD Register: PI214a].
142. Goldman MH, Shuster A, Haliburn C, Doring G. A randomised, open label phase 3 study to evaluate the efficacy and safety of a dry powder formulation of colistimethate sodium (Colobreathe®) versus tobramycin nebuliser solution (TNS) in cystic fibrosis subjectes with chronic Pseudomonas aeruginosa lung infection [abstract]. Pediatric Pulmonology 2012;47(S35):353, Abstract no: 363. [CENTRAL: 849030; CFGD Register: PI214c; CRS: 5500100000010631].
143. Goldman MH, Werner T, Schuster A. Does persistence with inhaled dry powder antibiotic treatment improve tolerability? [abstract]. Pediatric Pulmonology 2013;48 Suppl 36:347, Abstract no: 389. [CENTRAL: 921669; CFGD Register: PI214f; CRS: 5500125000000396].
144. Schuster A, Haliburn C, Doring G, Goldman MH, FSG. Online Data Supplement to 'Safety, efficacy and convenience of colistimethate sodium dry powder for inhalation (Colobreathe DPI) in patients with cystic fibrosis: a randomised' [online] study. Thorax 2013;68(4):344-350 Online. [CENTRAL: 867327; CFGD Register: PI214e; CRS: 5500100000011299].
145. Schuster A, Haliburn C, Doring G, Goldman MH, FSG. Safety, efficacy and convenience of colistimethate sodium dry powder for inhalation (Colobreathe DPI) in patients with cystic fibrosis: a randomised study. Thorax 2013;68(4):344-50. [CENTRAL: 864435; CFGD Register: PI214d; CRS: 5500100000011298; PUBMED: 23135343].
146. Steinkamp G, Tummler B, Malkotte R, Von der Hardt H. Treatment of Pseudomonas aeruginosa colonisation in cystic fibrosis. Archives of Disease in Childhood 1989;64(7):1022-8.
147. Steinkamp G, Schmitt-Grohe S, Doring G, Stabb D, Schubert R, Zielen S. Once weekly azithromycin in cystic fibrosis: a double-blind, randomised trial in patients with chronic Pseudomonas aeruginosa infection [abstract]. Pediatric Pulmonology 2007;42(S30):300. [CFGD Register: MA19b].
148. Steinkamp G, Schmitt-Grohe S, Doring G, Worlitzsch D, Staab D, Schubert R, et al.Clinical and immunomodulatory effects of once weekly azithromycin treatment in cystic fibrosis patients chronically infected with Pseudomonas aeruginosa [abstract]. Journal of Cystic Fibrosis 2006;5 Suppl 1:S25. [CFGD Register: MA19a].
149. Taccetti G, Campana S, Festini F, Mascherini M, Doring G. Early eradication therapy against Pseudomonas aeruginosa in cystic fibrosis patients. European Respiratory Journal 2005;26(3):1-4.
150. Tramper-Stranders G, Wolfs TFW, van Aalderen W, Kouwenberg J, Nagelkerke A, van der Ent CK. Prevention of initial P. aeruginosa infection in children with cystic fibrosis: a multi-centre double-blind randomised controlled trial [abstract]. Journal of Cystic Fibrosis 2009;8 Suppl 2:S37, Abstract no: 148. [CFGD Register: PI231a; MEDLINE: 96296083].
151. Tramper-Stranders GA, Wolfs TF, van Haren Noman S, van Aalderen WM, Nagelkerke AF, Nuijsink M, et al.Controlled trial of cycled antibiotic prophylaxis to prevent initial Pseudomonas aeruginosa infection in children with cystic fibrosis. Thorax 2010;65(10):915-20. [CENTRAL: 761942; CFGD Register: PI231b; CRS: 5500125000000359; PUBMED: 20729233].
152. McColley SA, Trapnell B, Kissner D, McKevitt M, Montgomery B, Rosen J, et al.Fosfomycin/tobramycin for inhalation (FTI): microbiological results of a phase 2 placebo-controlled trial in patients with cystic fibrosis and pseudomonas aeruginosa [abstract]. Pediatric Pulmonology 2010;45 Suppl 33:338, Abstract no: 334. [CENTRAL: 848865; CFGD Register: PI247c; CRS: 5500100000010542].
153. Trapnell BC, Kissner D, Montgomery AB, Newcomb T, Geller D. Fosfomycin/tobramycin for inhalation FTI): safety results of a phase 2 placebo-controlled trial in patients with cystic fibrosis and pseudomonas aeruginosa [abstract]. Pediatric Pulmonology 2010;45 Suppl 33:302, Abstract no: 234. [CENTRAL: 848864; CFGD Register: PI247b; CRS: 5500100000010541].
154. Trapnell BC, McColley SA, Kissner DG, Rolfe MW, Rosen JM, McKevitt M, et al.Fosfomycin/tobramycin for inhalation in patients with cystic fibrosis with pseudomonas airway infection. American Journal of Respiratory and Critical Care Medicine 2012;185(2):171-8. [CENTRAL: 814492; CFGD Register: PI247d; CRS: 5500100000010632].
155. Trapnell BC, Rolfe M, McColley S, Montgomery AB, Moorehead L, Geller D. Fosfomycon/tobramycin for inhalation (FTI): efficacy results of a phase 2 placebo-controlled trial in patients with cystic fibrosis and pseudomonas aeruginosa [abstract]. Pediatric Pulmonology 2010;45 Suppl 33:302, Abstract no: 233. [CENTRAL: 848927; CFGD Register: PI247a; CRS: 5500100000010712].
156. Vazquez C, Municio M, Corera M, Gaztelurrutia L, Sojo A, Vitoria JC. Early treatment of Pseudomonas aeruginosa colonisation in cystic fibrosis. Acta Paediatrica Scandanavia 1993;82(3):308-9.
157. Byrnes CA, Vidmar S, Cheney JL, Carlin JB, Armstrong DS, Cooper PJ, et al.Prospective evaluation of respiratory exacerbations in children with cystic fibrosis from newborn screening to 5 years of age. Thorax 2013;68(7):643-51. [CENTRAL: 904924; CFGD Register: PE167i; CRS: 5500125000000477; PUBMED: 23345574].
158. Cheney J, Vidmar S, Grimwood K, Carlin JB, Wainwright C, on behalfofACFBALSG. Interim outcomes of a Pseudomonas aeruginosa (Pa) eradication protocol in young children in the Australian Cystic Fibrosis Bronchoalveolar Lavage (ACFBAL) Study [abstract]. Journal of Cystic Fibrosis 2009;8(Suppl 2):S39, Abstract no:157. [CFGD Register: PE167c].
159. Cheney J, Wainwright C, ACFBAL SG. Trials, tribulations and triumphs of a cystic fibrosis study - a behind the scenes look at the workings of an international multi-centre study [abstract]. Journal of Cystic Fibrosis 2010;9 Suppl 1:S118, Abstract no: 452. [CENTRAL: 790042; CFGD Register: PE167g; CRS: 5500125000000092].
160. Wainwright C, Carlin J, Cooper P, Byrnes C, Martin J, Grimwood K, et al.Australasian cystic fibrosis BAL study interim analysis [abstract]. Pediatric Pulmonology 2006;41 Suppl 29:317. [CFGD Register: PE167a].
161. Wainwright CE, Carlin J, Cooper P, Byrnes C, Whitehead B, Martin J, et al.Early infection with pseudomonas aeruginosa can be cleared in young children with cystic fibrosis [abstract]. Pediatric Pulmonology 2002;34 Suppl 24:300-1. [CFGD Register: PI167d].
162. Wainwright CE, Kidd TJ, Ramsey KA, Bell SC, Grimwood K. Australasian CF bronchoalveolar lavage (ACFBAL) study: P.Aeruginosa (PA) genotypes in pre-school CF children [abstract]. Pediatric Pulmonology 2011;46 Suppl 34:320, Abstract no: 299. [CENTRAL: 874662; CFGD Register: PE167h; CRS: 5500125000000093].
163. Wainwright CE, Vidmar S, Armstrong DS, Byrnes CA, Carlin JB, Cheney J, et al.Effect of bronchoalveolar lavage-directed therapy on Pseudomonas aeruginosa infection and structural lung injury in children with cystic fibrosis: a randomized trial. JAMA 2011;306(2):163-71. [CFGD Register: PI167e].
164. Wainwright CE, Vidmar S, Armstrong DS, Byrnes CA, Carlin JB, Cheney J, et al.Online Supplement to 'Effect of bronchoalveolar lavage-directed therapy on Pseudomonas aeruginosa infection and structural lung injury in children with cystic fibrosis: a randomized trial' [online]. JAMA 2011;306(2):163-171 Online. [CENTRAL: 788878; CFGD Register: PE167f; CRS: 5500100000011126; PUBMED: 21750293].
165. Wainwright CE, Grimwood K, Carlin JB, Vidmar S, Cooper PJ, Francis PW, et al.Safety of bronchoalveolar lavage in young children with cystic fibrosis. Pediatric Pulmonology 2008;43(10):965-72. [CFGD Register: PI167b].
166. Wainwright CE, Quittner AL, Geller DE, Nakamura C, Wooldridge JL, Gibson RL, et al.Aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis, mild lung impairment, and P. aeruginosa. Journal of Cystic Fibrosis 2011;10(4):234-42. [CENTRAL: 801029; CFGD Register: PI273; CRS: 5500100000011273; PUBMED: 21441078].
167. Noah T, Ivins S, Abode K, Harris W, Henry M, Leigh M. Comparison of antibiotics for early pseudomonas infection in CF: interim data analysis [abstract]. Pediatric Pulmonology 2007;42(S30):332. [CFGD Register: PI205a].
168. Noah TL, Ivins SS, Abode KA, Stewart PW, Michelson PH, Harris WT, et al.Inhaled versus systemic antibiotics and airway inflammation in children with cystic fibrosis and Pseudomonas. Pediatric Pulmonology 2010;45(3):281-90. [CFGD Register: PI205b].
169. Langton Hewer S. TORPEDO-CF. http://www.controlled-trials.com/ISRCTN02734162/torpedo-cf accessed 10 October 2011. [: ISRCTN02734162].
170. Abman SH, Ogle JW, et al.Early bacteriologic, immunologic and clinical courses of young infants with cystic fibrosis identified by neonatal screening. Journal of Pediatrics 1991;119(2):211-7.
171. Anstead M, Heltshe S, Khan U, Barbieri JT, Langkamp M, Doring G, et al.Pseudomonas aeruginosa serology and risk for re-isolation in the EPIC trial. Journal of Cystic Fibrosis 2013;12(2):147-53.
172. Armstrong D, Grimwood K, Carlin J, Carzino R, Olinsky A, Phelan P. Bronchoalveolar lavage or oropharyngeal cultures to identify lower respiratory pathogens in infants with cystic fibrosis. Pediatric Pulmonology 1996;21(5):267-75.
173. Burns JL, Gibson RL, McNamara S, Yim D, Emerson J, Rosenfeld M, et al.Longitudanal assessment of Pseudomonas aeruginosa in young children with cystic fibrosis. Journal of Infectious Diseases 2001;183(3):444-52.
174. Ciofu O, Mandsberg LF, Wang H, Hoiby N. Phenotypes selected during chronic lung infection in cystic fibrosis patients: implications for the treatment of Pseudomonas aeruginosa biofilm infections. FEMS Immunology and Medical Microbiology 2012;65(2):215-25.
175. Douglas TA, Brennan S, Gard S, Berry L, Gangell C, Stick SM, et al.Acquisition and eradication of P. aeruginosa in young children with cystic fibrosis. European Respiratory Journal 2009;33(2):305-11.
176. Döring G, Conway S, Heijerman H, Hodson M, Høiby N, Smyth A, et al.Antibiotic therapy against Pseudomonas aeruginosa: a European consensus. European Respiratory Journal 2000;16(4):749-67.
177. Döring G, Flume P, Heijerman H, Elborn JS. Treatment of lung infection in patients with cystic fibrosis: Current and future strategies. Journal of Cystic Fibrosis 2012;11(6):461-79.
178. Emerson J, Rosenfeld M, McNamara S, Ramsey B, Gibson RL. Pseudomonas aeruginosa and other predictors of mortality and morbidity in young children with cystic fibrosis. Pediatric Pulmonology 2002;34(2):91-100.
179. FitzSimmons SC. The changing epidemiology of cystic fibrosis. Journal of Pediatrics 1993;122(1):1-9.
180. Fitzsimmons S. The Cystic Fibrosis Foundation Patient Registry Report 1996. Pediatric Pulmonology 1996;Suppl 21:267-75.
181. Higgins JPT, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. BMJ 2003;327(7414):557-60.
182. Higgins JPT, Altman DG. Chapter 8: Assessing risk of bias in included studies. In: Higgins JPT, Green S (editors). Cochrane Handbook of Systematic Reviews of Interventions. Version 5.1 [updated March 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane-handbook.org.
183. Hilliard TN, Sukhani S, Francis J, Madden N, Rosenthal M, Balfour-Lynn I, et al.Bronchoscopy following diagnosis with cystic fibrosis. Archives of Disease in Childhood 2007;92(10):989-9.
184. Hudson V, Wielinski C, Regelmann W. Prognostic implications of initial oropharyngeal bacterial flora in patients with cystic fibrosis diagnosed before the age of two years. Journal of Pediatrics 1993;122(6):854-60.
185. Iacocca VF, Sibinga M, Barbero G. Respiratory Tract Bacteriology in Cystic Fibrosis. American Journal of Disease in Childhood 1963;106(3):115-24.
186. Johansen HK, Gøtzsche PC. Vaccines for preventing infection with Pseudomonas aeruginosa in cystic fibrosis. Cochrane Database of Systematic Reviews 2013, Issue 6. [DOI: 10.1002/14651858.CD001399.pub3].
187. Kerem E, Corey M, Stein R, Gold R, Levison H. Risk factors for Pseudomonas aeruginosa colonisation in cystic fibrosis patients. Pediatric Infectious Disease Journal 1990;9(7):494-8.
188. Kosorok MR, Zeng L, West SE, Rock MJ, Splaingard ML, Laxova A, et al.Acceleration of lung disease in children with cystic fibrosis after Pseudomonas aeruginosa acquisition. Pediatric Pulmonology 2001;32(4):277-87.
189. Lee TWR, Brownlee KG, Conway SP, Denton M, Littlewood JM. Evaluation of a new definition for chronic Pseudomonas aeruginosa infection in cystic fibrosis patients. Journal of Cystic Fibrosis 2003;2(1):29-34.
190. Lee TW, Brownlee KG, Denton M, Littlewood JM, Conway SP. Reduction in prevalence of chronic Pseudomonas aeruginosa infection at a regional pediatric cystic fibrosis center. Pediatric Pulmonology 2004;37(2):104-10.
191. Lee TWR. Eradication of early Pseudomonas infection in cystic fibrosis. Chronic Respiratory Disease 2009;6(2):99-107.
192. Montori VM, Devereaux PJ, Adhikari NKJ, Burns KEA, Eggert CH, Briel M, et al.Randomized Trials Stopped Early for Benefit: A Systematic Review. JAMA 2005;294(17):2203-9.
193. Muhlebach M, Stewart P, Leigh M, Noah T. Quantitation of inflammatory responses to bacteria in young cystic fibrosis and control patients. American Journal of Respiratory & Critical Care Medicine 1999;160(1):186-91.
194. Munck A, Bonacorsi S, Mariani-Kurkdjian P, Lebourgeois M, Gerardin M, Brahimi N, et al.Genotypic characterisation of Pseudomonas aeruginosa strains recovered from patients with cystic fibrosis after initial and subsequent colonisation. Pediatric Pulmonology 2001;32(4):288-92.
195. Nixon GM, Armstrong DS, Carzino R, Carlin JB, Olinsky A, Robertson CF, et al.Clinical outcome after early Pseudomonas aeruginosa infection in cystic fibrosis. Journal of Pediatrics 2001;138(5):699-704.
196. Pamukcu A, Bush A, Buchdal R. Effects of Pseudomonas aeruginosa colonisation on lung function and anthropomorphic variables in children with cystic fibrosis. Pediatric Pulmonology 1995;19(1):10-5.
197. Parad RB, Gerard CJ, Zurakowski D, Nichols DP, Pier GB. Pulmonary outcome in cystic fibrosis is influenced primarily by mucoid Pseudomonas aeruginosa infection and immune status and only modestly by genotype. Infection & Immunity 1999;67(9):4744-50.
198. Ramsey B. Drug therapy: Management of pulmonary disease in patients with cystic fibrosis. New England Journal of Medicine 1996;335(3):179-88.
199. Ratjen F, Comes G, Paul K, Posselt H, Wagner T, Harms K. Effect of continuous antistaphylococcal therapy on the rate of P.aeruginosa acquisition in patients with cystic fibrosis. Pediatric Pulmonology 2001;31(1):13-6.
200. Rosenfeld M, Emerson J, Accurso F, Armstrong D, Castille R, Grimwood K, et al.Diagnostic accuracy of oropharyngeal cultures in infants and young children with cystic fibrosis. Pediatric Pulmonology 1999;28(5):321-8.
201. Rosenfeld MR, Gibson RL, McNamara S, Emerson J, Burns JL, Castile R, et al.Early pulmonary infection, inflammation and clinical outcomes in infants with cystic fibrosis. Pediatric Pulmonology 2001;32(5):356-66.
202. Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in randomised controlled trials. JAMA 1995;273(5):408-12.
203. Smyth AR, Walters S. Prophylactic anti-staphylococcal antibiotics for cystic fibrosis. Cochrane Database of Systematic Reviews 2012, Issue 12. [DOI: 10.1002/14651858.CD001912].
204. Smyth AR, Bell SC, Bojcin S, Bryon M, Duff A, Flume P, et al.European Cystic Fibrosis Society Standards of Care: Best Practice Guidelines. Journal of Cystic Fibrosis 2014;13(Supplement 1):S23-S42.
205. Stutman HR, Lieberman JM, Nussbaum E, Marks MI. Antibiotic prophylaxis in infants and young children with cystic fibrosis: a randomised controlled trial. Journal of Pediatrics 2002;140(3):299-305.
206. Thomassen MJ, Klinger JD, Badger SJ, Van Herckren BW, Stern RC. Cultures of thoracotomy specimens confirm usefulness of sputum cultures in cystic fibrosis. Journal of Pediatrics 1984;104(3):352-6.
207. UK CF Trust. Cystic Fibrosis Trust Patient Registry User's Guide. Bromley: UK CF Trust, 2012.
208. UK Cystic Fibrosis Trust. UK CF Registry: Annual Data Report 2013. Bromley: Cystic Fibrosis Trust, 2014.
209. UK CF Trust Control of Infection Group. Pseudomonas aeruginosa infection in people with cystic fibrosis: suggestions for prevention and control (2nd edition). UK CF Trust 2004.
210. Winnie GB, Cowan RG. Respiratory tract colonisation with Pseudomonas aeruginosa in cystic fibrosis: correlations between anti-Pseudomonas aeruginosa antibody levels and pulmonary function. Pediatric Pulmonology 1991;10(2):92-100.
211. Langton Hewer SC, Smyth AR. Antibiotic strategies for eradicating Pseudomonas aeruginosa in people with cystic fibrosis. Cochrane Database of Systematic Reviews 2009, Issue 4. [DOI: 10.1002/14651858.CD004197.pub3].
212. Wood DM, Smyth A. Antibiotic strategies for eradicating Pseudomonas aeruginosa in people with cystic fibrosis. Cochrane Database of Systematic Reviews 2003, Issue 2. [DOI: 10.1002/14651858.CD004197].
213. Wood DM, Smyth AR. Antibiotic strategies for eradicating Pseudomonas aeruginosa in people with cystic fibrosis. Cochrane Database of Systematic Reviews 2006, Issue 1. [DOI: 10.1002/14651858.CD004197.pub2].