Novel inhaled combined antibiotic formulations in the treatment of Pseudomonas aeruginosa airways infections in cystic fibrosis

Expert Review of Anti-Infective Therapy

Volumn 13, Issue 7, 2015, Pages 897-905

  Antoniu, Sabina ^a  

^a GRIGORE T POPA UNIVERSITY OF MEDICINE AND PHARMACY   (Romania)

Author keywords

Tobramycin

Indexed keywords

AMIKACIN; AMINOGLYCOSIDE DERIVATIVE; BAY 416551; CIPROFLOXACIN; CLARITHROMYCIN; COLISTIN; FOSFOMYCIN; MACROLIDE; PLACEBO; QUINOLONE DERIVATIVE; TOBRAMYCIN; UNCLASSIFIED DRUG; ANTIINFECTIVE AGENT; DRUG COMBINATION;

ACINETOBACTER BAUMANNII; ANTIBACTERIAL ACTIVITY; ANTIINFLAMMATORY ACTIVITY; BACTERIAL COLONIZATION; BACTERIAL LOAD; BACTERIAL STRAIN; BURKHOLDERIA; BURKHOLDERIA CEPACIA; CHRONIC OBSTRUCTIVE LUNG DISEASE; CLINICAL TRIAL (TOPIC); CONCENTRATION RESPONSE; COUGHING; CYSTIC FIBROSIS; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG FORMULATION; DRUG MECHANISM; DRUG MEGADOSE; DRUG POTENTIATION; DRUG SAFETY; DRY POWDER; DYSPNEA; GRAM NEGATIVE INFECTION; HAEMOPHILUS INFLUENZAE; HUMAN; IN VITRO STUDY; LOW DRUG DOSE; MINIMUM INHIBITORY CONCENTRATION; NEBULIZATION; NEPHROTOXICITY; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PSEUDOMONAS AERUGINOSA; PSEUDOMONAS INFECTION; RESPIRATORY TRACT INFECTION; REVIEW; TREATMENT DURATION; VENTILATOR ASSOCIATED PNEUMONIA; DRUG COMBINATION; DRUG EFFECTS; INHALATIONAL DRUG ADMINISTRATION; PROCEDURES; PSEUDOMONAS INFECTIONS; RESPIRATORY TRACT INFECTIONS; TREATMENT OUTCOME;

ADMINISTRATION, INHALATION; ANTI-BACTERIAL AGENTS; CLINICAL TRIALS AS TOPIC; CYSTIC FIBROSIS; DRUG COMBINATIONS; FOSFOMYCIN; HUMANS; PSEUDOMONAS AERUGINOSA; PSEUDOMONAS INFECTIONS; RESPIRATORY TRACT INFECTIONS; TOBRAMYCIN; TREATMENT OUTCOME;

EID: 84931086617     PISSN: 14787210     EISSN: 17448336     Source Type: Journal    
DOI: 10.1586/14787210.2015.1041925     Document Type: Review

References (61)

1. Hill SL, Morrison HM, Burnett D, et al. Short term response of patients with bronchiectasis to treatment with amoxycillin given in standard or high doses orally or by inhalation. Thorax 1986; 41(7): 559-65
2. Michalopoulos AS, Livaditis IG, Gougoutas V. The revival of fosfomycin. Int J Infect Dis 2011; 15(11): e732-9
3. Khan IU, Mirza IA, Ikram A, et al. In vitro activity of fosfomycin tromethamine against extended spectrum beta-lactamase producing urinary tract bacteria. J Coll Physicians Surg Pak 2014; 24(12): 914-17
4. Rodrguez-Martnez JM, Ballesta S, Pascual A. Activity and penetration of fosfomycin, ciprofloxacin, amoxicillin/clavulanic acid and co-Trimoxazole in Escherichia coli and Pseudomonas aeruginosa biofilms. Int J Antimicrob Agents 2007; 30(4): 366-8
5. Morikawa K, Oseko F, Morikawa S. Immunomodulatory effect of fosfomycin on human B-lymphocyte function. Antimicrob Agents Chemother 1993; 37(2): 270-5
6. Morikawa K, Oseko F, Morikawa S, Sawada M. Immunosuppressive activity of fosfomycin on human T-lymphocyte function in vitro. Antimicrob Agents Chemother 1993; 37(12): 2684-7
7. Mirakhur A, Gallagher MJ, Ledson MJ, et al. Fosfomycin therapy for multiresistant Pseudomonas aeruginosa in cystic fibrosis. J Cyst Fibros 2003; 2(1): 19-24
8. Faruqi S, McCreanor J, Moon T, et al. Fosfomycin for Pseudomonas-related exacerbations of cystic fibrosis. Int J Antimicrob Agents 2008; 32(5): 461-3
9. Lam J, Vaughan S, Parkins MD. Tobramycin inhalation powder (TIP): an efficient treatment strategy for the management of chronic Pseudomonas aeruginosa infection in cystic fibrosis. Clin Med Insights Circ Respir Pulm Med 2013; 7: 61-77
10. Smith AL. Inhaled antibiotic therapy: What drug? What dose? What regimen? What formulation? J Cyst Fibros 2002; 1(2(Suppl 0): 189-93
11. Ramsey BW, Pepe MS, Quan JM, et al. Intermittent administration of inhaled tobramycin in patients with cystic fibrosis. N Engl J Med 1999; 340(1): 23-30
12. Barker AF, Couch L, Fiel SB, et al. Tobramycin solution for inhalation reduces sputum Pseudomonas aeruginosa density in bronchiectasis. Am J Respir Crit Care Med 2000; 162(2): 481-5
13. Gibson RL, Emerson J, Mayer-Hamblett N, et al. Duration of treatment effect after tobramycin solution for inhalation in young children with cystic fibrosis. Pediatr Pulmonol 2007; 42(7): 610-23
14. Ratjen F, Munck A, Kho P, et al. Treatment of early Pseudomonas aeruginosa infection in patients with cystic fibrosis: the ELITE trial. Thorax 2010; 65(4): 286-91
15. Sands D, Sapiejka E, Ga?szczyk G, et al. Comparison of two tobramycin nebuliser solutions: pharmacokinetic, efficacy and safety profiles of T100 and TNS. J Cyst Fibros 2014; 13(6): 653-60
16. Konstan MW, Flume PA, Kappler M, et al. Safety, efficacy and convenience of tobramycin inhalation powder in cystic fibrosis patients: The EAGER trial. J Cyst Fibros 2011; 10(1): 54-61
17. Lam J, Vaughan S, Parkins MD. Tobramycin inhalation powder (TIP): an efficient treatment strategy for the management of chronic Pseudomonas aeruginosa infection in cystic fibrosis. Clin Med Insights Circ Respir Pulm Med 2013; 7: 61-77
18. Mazurek H, Chiron R, Kucerova T, et al. Long-Term efficacy and safety of aerosolized tobramycin 300mg/4ml in cystic fibrosis. Pediatr Pulmonol 2014; 49(11): 1076-89
19. Dal Negro R, Micheletto C, Tognella S, et al. Tobramycin nebulizer solution in severe COPD patients colonized with Pseudomonas aeruginosa: effects on bronchial inflammation. Adv Ther 2008; 25(10): 1019-30
20. Konstan MW, Geller DE, Minic-P, et al. Tobramycin inhalation powder for P. aeruginosa infection in cystic fibrosis: The EVOLVE trial. Pediatr Pulmonol 2011; 46(3): 230-8
21. Mohr AM, Sifri ZC, Horng HS, et al. Use of aerosolized aminoglycosides in the treatment of Gram-negative ventilatorassociated pneumonia. Surg Infect (Larchmt) 2007; 8(3): 349-58
22. Dhand R. The role of aerosolized antimicrobials in the treatment of ventilator-Associated pneumonia. Respir Care 2007; 52(7): 866-84
23. Le Conte P, Potel G, Peltier P, et al. Lung distribution and pharmacokinetics of aerosolized tobramycin. Am Rev Respir Dis 1993; 147(5): 1279-82
24. Antoniu S, Azoicai D. Novel amikacin inhaled formulation for the treatment of lower respiratory tract infections. Drugs Today (Barc) 2013; 49(11): 683-92
25. Okusanya OO, Bhavnani SM, Hammel JP, et al. Evaluation of the pharmacokinetics and pharmacodynamics of liposomal amikacin for inhalation in cystic fibrosis patients with chronic pseudomonal infections using data from two phase 2 clinical studies. Antimicrob Agents Chemother 2014; 58(9): 5005-15
26. Dupont L, Clancy JP, Minic P, et al. Evaluation of two phase II blinded and placebo-controlled studies of nebulized liposomal amikacin (Arikace) in the treatment of cystic fibrosis patients with Pseudomonas aeruginosa lung infection. Am J Respir Crit Care Med 2010; 181: A1836
27. Clancy JP, Dupont L, Konstan MW, et al. Phase II studies of nebulised Arikace in CF patients with Pseudomonas aeruginosa infection. Thorax 2013; 68(9): 818-25
28. Niederman MS, Chastre J, Corkery K, et al. BAY41-6551 achieves bactericidal tracheal aspirate amikacin concentrations in mechanically ventilated patients with Gram-negative pneumonia. Intensive Care Med 2012; 38(2): 263-71
29. Jensen T, Pedersen SS, Garne S, et al. Colistin inhalation therapy in cystic fibrosis patients with chronic Pseudomonas aeruginosa lung infection. J Antimicrob Chemother 1987; 19(6): 831-8
30. Antoniu SA, Cojocaru I. Inhaled colistin for lower respiratory tract infections. Expert Opin Drug Deliv 2012; 9(3): 333-42
31. Shirk MB, Donahue KR, Shirvani J. Unlabeled uses of nebulized medications. Am J Health Syst Pharm 2006; 63(18): 1704-16
32. Serisier DJ, Bilton D, De Soyza A, et al. Inhaled, dual release liposomal ciprofloxacin in non-cystic fibrosis bronchiectasis (ORBIT-2): a randomised, double-blind, placebo-controlled trial. Thorax 2013; 68(9): 812-17
33. Stass H, Weimann B, Nagelschmitz J, et al. Tolerability and pharmacokinetic properties of ciprofloxacin dry powder for inhalation in patients with cystic fibrosis: a phase i, randomized, dose-escalation study. Clin Ther 2013; 35(10): 1571-81
34. Stass H, Weimann B, Nagelschmitz J, et al. Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis: a phase II randomised study. Eur Respir J 2013; 41(5): 1107-15
35. Clancy JP, Dupont L, Konstan MW, et al. Phase II studies of nebulised Arikace in CF patients with Pseudomonas aeruginosa infection. Thorax 2013; 68(9): 818-25
36. Siekmeier R, Hofmann T, Scheuch G. Inhalation of macrolides: a novel approach to treatment of pulmonary infections, in Pokorski M, editor. Inflammatory Disorders. Springer International Publishing; 2015. p. 13-24
37. Haghi M, Saadat A, Zhu B, et al. Immunomodulatory effects of a low-dose clarithromycin-based macrolide solution pressurised metered dose inhaler. Pharm Res 2014; 1-10. [Epub ahead of print]
38. Robinson P, Schechter MS, Sly PD, et al. Clarithromycin therapy for patients with cystic fibrosis: a randomized controlled trial. Pediatr Pulmonol 2012; 47(6): 551-7
39. Fouka E, Lamprianidou E, Arvanitidis K, et al. Low-dose clarithromycin therapy modulates Th17 response in non-cystic fibrosis bronchiectasis patients. Lung 2014; 192(6): 849-55
40. Togami K, Chono S, Morimoto K. Aerosol-based efficient delivery of azithromycin to alveolar macrophages for treatment of respiratory infections. Pharm Dev Technol 2013; 18(6): 1361-5
41. Young PM, Salama RO, Zhu B, et al. Multi-breath dry powder inhaler for delivery of cohesive powders in the treatment of bronchiectasis. Drug Dev Ind Pharm 2014. [Epub ahead of print]
42. Alhajlan M, Alhariri M, Omri A. Efficacy and safety of liposomal clarithromycin and its effect on Pseudomonas aeruginosa virulence factors. Antimicrob Agents Chemother 2013; 57(6): 2694-704
43. Saadat A, Zhu B, Haghi M, et al. The formulation, chemical and physical characterisation of clarithromycin-based macrolide solution pressurised metered dose inhaler. J Pharm Pharmacol 2014; 66(5): 639-45
44. Togami K, Chono S, Morimoto K. Aerosol-based efficient delivery of clarithromycin, a macrolide antimicrobial agent, to lung epithelial lining fluid and alveolar macrophages for treatment of respiratory infections. J Aerosol Med Pulmonary Drug Delivery 2012; 25(2): 110-15
45. MacLeod DL, Barker LM, Sutherland JL, et al. Antibacterial activities of a fosfomycin/tobramycin combination: a novel inhaled antibiotic for bronchiectasis. J Antimicrob Chemother 2009; 64(4): 829-36
46. MacLeod DL, Velayudhan J, Kenney TF, et al. Fosfomycin enhances the active transport of tobramycin in Pseudomonas aeruginosa. Antimicrob Agents Chemother 2012; 56(3): 1529-38
47. McCaughey G, McKevitt M, Elborn JS, Tunney MM. Antimicrobial activity of fosfomycin and tobramycin in combination against cystic fibrosis pathogens under aerobic and anaerobic conditions. J Cyst Fibros 2012; 11(3): 163-72
48. Anderson GG, Kenney TF, Macleod DL, et al. Eradication of Pseudomonas aeruginosa biofilms on cultured airway cells by a fosfomycin/tobramycin antibiotic combination. Pathog Dis 2013; 67(1): 39-45
49. Trapnell BC, McColley SA, Kissner DG, et al. Fosfomycin/tobramycin for inhalation in patients with cystic fibrosis with Pseudomonas airway infection. Am J Respir Crit Care Med 2012; 185(2): 171-8
50. Montgomery AB, Rhomberg PR, Abuan T, et al. Potentiation effects of amikacin and fosfomycin against selected amikacin-nonsusceptible Gram-negative respiratory tract pathogens. Antimicrob Agents Chemother 2014; 58(7): 3714-19
51. Montgomery AB, Rhomberg PR, Abuan T, et al. Amikacin-fosfomycin at a five-To-Two ratio: characterization of mutation rates in microbial strains causing ventilator-Associated pneumonia and interactions with commonly used antibiotics. Antimicrob Agents Chemother 2014; 58(7): 3708-13
52. Montgomery AB, Vallance S, Abuan T, et al. A randomized double-blind placebocontrolled dose-escalation phase 1 study of aerosolized amikacin and fosfomycin delivered via the PARI Investigational eFlow-Inline Nebulizer System in mechanically ventilated patients. J Aerosol Med Pulm Drug Deliv 2014; 27(6): 441-8
53. Schultz MJ. Macrolide activities beyond their antimicrobial effects: macrolides in diffuse panbronchiolitis and cystic fibrosis. J Antimicrob Chemother 2004; 54(1): 21-8
54. Tré-Hardy M, Mace-C, El Manssouri N, et al. Effect of antibiotic co-Administration on young and mature biofilms of cystic fibrosis clinical isolates: the importance of the biofilm model. Int J Antimicrob Agents 2009; 33(1): 40-5
55. Tré-Hardy M, Traore H, El Manssouri N, et al. Evaluation of long-Term coadministration of tobramycin and clarithromycin in a mature biofilm model of cystic fibrosis clinical isolates of Pseudomonas aeruginosa. Int J Antimicrob Agents 2009; 34(4): 370-4
56. Pilcer G, De Bueger V, Traina K, et al. Carrier-free combination for dry powder inhalation of antibiotics in the treatment of lung infections in cystic fibrosis. Int J Pharm 2013; 451(1-2): 112-20
57. Tré-Hardy M, Nagant C, El Manssouri N, et al. Efficacy of the combination of tobramycin and a macrolide in an in vitro Pseudomonas aeruginosa mature biofilm model. Antimicrob Agents Chemother 2010; 54(10): 4409-15
58. Pilcer G, Rosière R, Traina K, et al. New co-spray-dried tobramycin nanoparticles-clarithromycin inhaled powder systems for lung infection therapy in cystic fibrosis patients. J Pharm Sci 2013; 102(6): 1836-46
59. Herrmann G, Yang L, Molin S, et al. Colistin sulfate/tobramycin combination is superior for killing biofilm P. aeruginosa than monotherapy in vitro. J Cyst Fibros 2009; 8(2 Suppl 0): S41
60. Herrmann G, Wu H, Song Z, et al. Colistin/tobramycin combinations for killing of P. aeruginosa biofilms in cystic fibrosis: a pre-clinical and clinical in vivo study. J Cyst Fibros 2010; 9(1 Suppl 0): S40
61. Lee SH, Teo J, Heng D, et al. A novel inhaled multi-pronged attack against respiratory bacteria. Eur J Pharm Sci 2015; 70: 37-44