Fosfomycin/tobramycin for inhalation in patients with cystic fibrosis with Pseudomonas airway infection

American Journal of Respiratory and Critical Care Medicine

Volumn 185, Issue 2, 2012, Pages 171-178

  Trapnell, Bruce C ^a,b   McColley, Susanna A ^c   Kissner, Dana G ^d   Rolfe, Mark W ^e   Rosen, Jonathan M ^f   McKevitt, Matthew ^g   Moorehead, Lisa ^g   Montgomery, A Bruce ^g   Geller, David E ^h  

^a CINCINNATI CHILDREN'S HOSPITAL MEDICAL CENTER   (United States)

^b UNIVERSITY OF CINCINNATI MEDICAL CENTER   (United States)

^c NORTHWESTERN UNIVERSITY   (United States)

^d HARPER UNIVERSITY HOSPITAL   (United States)

^e New Lungs Associates   (United States)

^f ALBANY MEDICAL COLLEGE   (United States)

^g GILEAD SCIENCES   (United States)

^h NEMOURS CHILDREN S HOSPITAL   (United States)

Author keywords

Fosfomycin; FTI; Inhaled antibiotics; Pseudomonas aeruginosa; Tobramycin

Indexed keywords

ANTIBIOTIC AGENT; AZTREONAM; FOSFOMYCIN PLUS TOBRAMYCIN; PLACEBO; UNCLASSIFIED DRUG;

ADULT; ARTICLE; CONTROLLED STUDY; COUGHING; DISEASE EXACERBATION; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DYSPNEA; FEMALE; FORCED EXPIRATORY VOLUME; GASTROINTESTINAL SYMPTOM; HUMAN; LABORATORY TEST; LUNG FIBROSIS; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PRIORITY JOURNAL; PSEUDOMONAS AERUGINOSA; PSEUDOMONAS INFECTION; RANDOMIZED CONTROLLED TRIAL; SPUTUM; WHEEZING;

ADMINISTRATION, INHALATION; ADULT; ANTI-BACTERIAL AGENTS; COUGH; CYSTIC FIBROSIS; DOUBLE-BLIND METHOD; DRUG COMBINATIONS; FEMALE; FORCED EXPIRATORY VOLUME; FOSFOMYCIN; HUMANS; MALE; MIDDLE AGED; PSEUDOMONAS AERUGINOSA; PSEUDOMONAS INFECTIONS; RESPIRATORY FUNCTION TESTS; TOBRAMYCIN; TREATMENT OUTCOME; UNITED STATES;

EID: 84856010859     PISSN: 1073449X     EISSN: 15354970     Source Type: Journal    
DOI: 10.1164/rccm.201105-0924OC     Document Type: Article

References (32)

1. Gibson RL, Burns JL, Ramsey BW. State of the art: pathophysiology and management of pulmonary infections in cystic fibrosis. Am J Respir Crit Care Med 2003;168:918-951. (Pubitemid 37267172)
2. Cystic Fibrosis Foundation Patient Registry. 2008 annual data report to the center directors. Bethesda, MD: Cystic Fibrosis Foundation; 2009.
3. Corey M, Edwards L, Levison H, Knowles M. Longitudinal analysis of pulmonary function decline in patients with cystic fibrosis. J Pediatr 1997;131:809-814. (Pubitemid 28027602)
4. Emerson J, McNamara S, Buccat AM, Worrell K, Burns JL. Changes in cystic fibrosis sputum microbiology in the United States between 1995 and 2008. Pediatr Pulmonol 2010;45:363-370.
5. Dasenbrook EC, Checkley W, Merlo CA, Konstan MW, Lechtzin N, Boyle MP. Association between respiratory tract methicillin-resistant Staphylococcus aureus and survival in cystic fibrosis. JAMA 2010;303:2386-2392.
6. Harris JK, De Groote MA, Sagel SD, Zemanick ET, Kapsner R, Penvari C, Kaess H, Deterding RR, Accurso FJ, Pace NR. Molecular identification of bacteria in bronchoalveolar lavage fluid from children with cystic fibrosis. Proc Natl Acad Sci USA 2007;104:20529-20533.
7. van Westreenen M, Tiddens HA. New antimicrobial strategies in cystic fibrosis. Paediatr Drugs 2010;12:343-352.
8. US Prescribing Information. TOBI (tobramycin inhalation solution, USP) [Internet]. East Hanover, NJ: Novartis Pharmaceuticals Corp; c2009 [revised 2009 Nov; accessed 2011 Mar 13]. Available from: http://www.pharma.us.novartis.com/ product/pi/pdf/tobi.pdf
9. US Prescribing Information. Cayston (aztreonam for inhalation solution) [Internet]. Foster City, CA: Gilead Sciences, Inc. [revised 2010 Feb; accessed 2011 Mar 13]. Available from: http://www.cayston.com/prescribing-info.html
10. Ramsey BW, Pepe MS, Quan JM, Otto KL, Montgomery AB, Williams-Warren J, Vasiljev-K M, Borowitz D, Bowman CM, Marshall BC, et al. Intermittent administration of inhaled tobramycin in patients with cystic fibrosis. Cystic Fibrosis Inhaled Tobramycin Study Group. N Engl J Med 1999;340:23-30. (Pubitemid 29024680)
11. Daikos GL, Jackson GG, Lolans VT, Livermore DM. Adaptive resistance to aminoglycoside antibiotics from first-exposure down-regulation. J Infect Dis 1990;162:414-420. (Pubitemid 20239957)
12. Appel GB. Aminoglycoside nephrotoxicity. Am J Med 1990:16S-20S; discussion 38S-42S.
13. Moskowitz SM, Silva SJ, Mayer-Hamblett N, Pasta DJ, Mink DR, Mabie JA, Konstan MW, Wagener JS; Investigators and Coordinators of the Epidemiologic Study of Cystic Fibrosis (ESCF). Shifting patterns of inhaled antibiotic use in cystic fibrosis. Pediatr Pulmonol 2008;43:874-881.
14. Tobramycin injection [package insert]. Irvine, CA: SICOR Pharmaceuticals, Inc.; 2005.
15. MacLeod DL, Barker LM, Sutherland JL, Moss SC, Gurgel JL, Kenney TF, Burns JL, Baker WR. Antibacterial activities of a fosfomycin/tobramycin combination: a novel inhaled antibiotic for bronchiectasis. J Antimicrob Chemother 2009;64:829-836.
16. Fosfomycin tromethamine (Monurol) [package insert]. St Louis, MO: Forest Pharmaceuticals, Inc.; 2007.
17. Inouye S, Watanabe T, Tsuruoka T, Kitasato I. An increase in the antimicrobial activity in vitro of fosfomycin under anaerobic conditions. J Antimicrob Chemother 1989;24:657-666. (Pubitemid 20005496)
18. Grif K, Dierich MP, Pfaller K, Miglioli PA, Allerberger F. In vitro activity of fosfomycin in combination with various antistaphylococcal substances. J Antimicrob Chemother 2001;48:209-217. (Pubitemid 32755281)
19. Hamilton-Miller JMT. In vitro activity of fosfomycin against 'problem'Gram-positive cocci. Microbios 1992;17:95-103.
20. Wilson J, Moorehead L, Montgomery B. A phase 1 open label trial to assess the safety and tolerability of fosfomycin/tobramycin for inhalation (FTI) in subjects with cystic fibrosis (CF) or bronchiectasis (BE) [abstract]. Pediatr Pulmonol 2008;43:320-321.
21. Wilson J, Moorehead L, Montgomery B. A phase 1 placebo-controlled, double-blind, randomized trial evaluating the safety and pharmacokinetics of three escalating doses of fosfomycin/tobramycin for inhalation (FTI) in healthy volunteers [abstract]. Pediatr Pulmonol 2008;43:321.
22. Quittner AL, Buu A, Messer MA, Modi AC, Watrous M. Development and validation of the cystic fibrosis questionnaire in the United States: a health related quality of life measure for cystic fibrosis. Chest 2005;128:2347-2354. (Pubitemid 41507578)
23. Quittner AL, Modi AC, Wainwright C, Otto K, Kirihara J, Montgomery AB. Determination of the minimal clinically important difference scores for the Cystic Fibrosis Questionnaire-Revised respiratory symptom scale in two populations of patients with cystic fibrosis and chronic Pseudomonas aeruginosa airway infection. Chest 2009;135:1610-1618.
24. Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, et al.; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J 2005;26:319-338. (Pubitemid 41079078)
25. Hankinson JL, Odencrantz JR, Fedan KB. Spirometric reference values from a sample of the general US population. Am J Respir Crit Care Med 1999;159:179-187. (Pubitemid 29036522)
26. Koch G, Stokes M, Davis C. Categorical data analysis using the SAS system, 2nd edition, 2000. Cary, NC: SAS Institute Inc.
27. Eisenberg J, Pepe M, Williams-Warren J, Vasiliev M, Montgomery AB, Smith AL, Ramsey BW. A comparison of peak sputum tobramycin concentration in patients with cystic fibrosis using jet and ultrasonic nebulizer systems. Aerosolized Tobramycin Study Group. Chest 1997;111:955-962. (Pubitemid 27171467)
28. MacLusky IB, Gold R, Corey M, Levison H. Long-term effects of inhaled tobramycin in patients with cystic fibrosis colonized with Pseudomonas aeruginosa. Pediatr Pulmonol 1989;7:42-48.
29. Oermann C, Assael BM, Nakamura C, Boas SR, Bresnik M, Montgomery AB, Pressler T. Aztreonam for inhalation solution (AZLI) vs. tobramycin inhalation solution (TIS): a 6-month comparative trial in cystic fibrosis (CF) patients with Pseudomonas aeruginosa (PA) [abstract]. Pediatr Pulmonol 2010;45:327.
30. Kastoris AC, Rafailidis PI, Vouloumanou EK, Gkegkes ID, Falagas ME. Synergy of fosfomycin with other antibiotics for Gram-positive and Gram-negative bacteria. Eur J Clin Pharmacol 2010;66:359-368.
31. MacLeod DL, Velayudhan J, Kenney T, Therrien J, Baker W. GS-9310/11 Mechanism of action: enhanced inhibition of protein synthesis [abstract]. Pediatr Pulmonol 2008;43:325.
32. Hunt BE, Weber A, Berger A, Ramsey B, Smith AL. Macromolecular mechanisms of sputum inhibition of tobramycin activity. Antimicrob Agents Chemother 1995;39:34-39.