Novel, single-dose microsphere formulation of azithromycin versus levofloxacin for the treatment of acute exacerbation of chronic bronchitis

Infectious Diseases in Clinical Practice

Volumn 13, Issue 3, 2005, Pages 115-121

  Zervos, Marcus ^a,b,d,e   Breen, Jeanne D ^c   Jorgensen, Daniel M ^c   Goodrich, James M ^c  

^a WILLIAM BEAUMONT HOSPITAL   (United States)

^b WAYNE STATE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c PFIZER INC   (United States)

^d HENRY FORD HOSPITAL   (United States)

^e WAYNE STATE UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AZITHROMYCIN; LEVOFLOXACIN; PLACEBO;

ADULT; ARTICLE; CHRONIC BRONCHITIS; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE EXACERBATION; DOUBLE BLIND PROCEDURE; DRUG TOLERABILITY; FEMALE; GENOTYPE; HAEMOPHILUS INFLUENZAE; HUMAN; MAJOR CLINICAL STUDY; MALE; MORAXELLA CATARRHALIS; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL; SAFETY; SMOKING; STREPTOCOCCUS PNEUMONIA;

EID: 18544369902     PISSN: 10569103     EISSN: None     Source Type: Journal    
DOI: 10.1097/01.idc.0000161504.41501.e7     Document Type: Article

References (42)

1. American Thoracic Society. Standards for the diagnosis and care of patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1995;152:S78-S120.
2. Niederman MS, McCombs JS, Unger AN, et al. Treatment cost of acute exacerbations of chronic bronchitis. Clin Ther. 1999;21:576-591.
3. Burrows B, Earle RH. Course and prognosis of chronic obstructive lung disease: a prospective study of 200 patients. N Engl J Med. 1969;280: 397-404.
4. Seemungal TA, Donaldson GC, Paul EA, et al. Effect of exacerbation on quality of life in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1998;157:1418-1422.
5. Ball P. Epidemiology and treatment of chronic bronchitis and its exacerbations. Chest. 1995;108(suppl 2):43S-52S.
6. Lode H. Respiratory tract infections: when is antibiotic therapy indicated? Clin Ther. 1991;13:149-156.
7. Miyashita N, Niki Y, Nakajima M, et al. Chlamydia pneumoniae infections in patients with diffuse panbronchiolitis and COPD. Chest. 1998;114:969-971.
8. Soler N, Torres A, Ewig S, et al. Bronchial microbial patterns in severe exacerbations of chronic obstructive pulmonary disease (COPD) requiring mechanical ventilation. Am J Respir Crit Care Med. 1998; 157:1498-1505.
9. Adams SG, Anzueto A. Antibiotic therapy in acute exacerbations of chronic bronchitis. Semin Respir Infect. 2000;15:234-247.
10. Adams SG, Melo J, Luther M, et al. Antibiotics are associated with lower relapse rates in outpatients with acute exacerbations of COPD. Chest. 2000;117:1345-1352.
11. Campbell GD Jr. The role of antimicrobial therapy in acute exacerbations of chronic bronchitis. Am J Med Sci. 1999;318:84-88.
12. Grossman RF. Cost-effective therapy for acute exacerbations of chronic bronchitis. Semin Respir Infect. 2000;15:71-81.
13. Niederman MS. Antibiotic therapy of exacerbations of chronic bronchitis. Semin Respir Infect. 2000;15(1):59-70.
14. Perfetto EM, Mullins CD, Subedi P, et al. Selection of clinical, patient-reported, and economic end points in acute exacerbation of chronic bronchitis. Clin Ther. 2001;23:1747-1772.
15. Read RC. Infection in acute exacerbations of chronic bronchitis: a clinical perspective. Respir Med. 1999;93:845-850.
16. Sethi S. Infectious exacerbations of chronic bronchitis: diagnosis and management. J Antimicrob Chemother. 1999;43(suppl A):97-105.
17. Wilson R. Evidence of bacterial infection in acute exacerbations of chronic bronchitis. Semin Respir Infect. 2000;15(3):208-215.
18. Wilson R, Grossman R. Introduction: the role of bacterial infection in chronic bronchitis. Semin Respir Infect. 2000;15:1-6.
19. Anthonisen NR, Manfreda J, Warren CP, et al. Antibiotic therapy in exacerbations of chronic obstructive pulmonary disease. Ann Intern Med. 1987;106:196-204.
20. Balter MS, La Forge J, Low DE, et al. Canadian guidelines for the management of acute exacerbations of chronic bronchitis. Can Respir J. 2003;10(suppl B):3B-32B.
21. Gomez FP, Rodriguez-Roisin R. Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines for chronic obstructive pulmonary disease. Curr Opin Pulm Med. 2002;8:81-86.
22. Amsden GW, Baird IM, Simon S, et al. Efficacy and safety of azithromycin vs levofloxacin in the outpatient treatment of acute bacterial exacerbations of chronic bronchitis. Chest. 2003;123:772-777.
23. DeAbate CA, Mathew CP, Warner JH, et al. The safety and efficacy of short course (5-day) moxifloxacin vs azithromycin in the treatment of patients with acute exacerbation of chronic bronchitis. Respir Med. 2000;94:1029-1037.
24. Hoepelman IM, Mollers MJ, van Schie MH, et al. A short (3-day) course of azithromycin tablets versus a 10-day course of amoxicillin-clavulanic acid (co-amoxiclav) in the treatment of adults with lower respiratory tract infections and effects on long-term outcome. Int J Antimicrob Agents. 1998;9:141-146.
25. Rothermel CD. Single-dose azithromycin for acute otitis media: a pharmacokinetic/pharmacodynamic rationale. Curr Ther Res. 2003; 64(suppl A):A4-A15.
26. Mandell GL. Delivery of antibiotics by phagocytes. Clin Infect Dis. 1994;19:922-925.
27. Schentag JJ, Ballow CH. Tissue-directed pharmacokinetics. Am J Med. 1991;91(suppl 3A):5S-11S.
28. Baldwin DR, Wise R, Andrews JM, et al. Azithromycin concentrations at the sites of pulmonary infection. Eur Respir J. 1990;3:886-890.
29. Rapp RP. Pharmacokinetics and pharmacodynamics of intravenous and oral azithromycin: enhanced tissue activity and minimal drug interactions. Ann Pharmacother. 1998;32:785-793.
30. Craig WA. Postantibiotic effects and the dosing of macrolides, azalides, and streptogramins. In: Zinner SH, Young LS, Acar JF, Neu HC, eds. Expanding Indications for the New Macrolides, Azalides and Streptogramins. New York: Marcel Dekker; 1997:27-38.
31. Girard D, Finegan SM, Cimochowski CR, et al. Accelerated dosing of azithromycin in preclinical infection models. Orlando, Fla: 102nd American Society for Microbiology General Meeting; May 2002. Abstract #A-57.
32. Kamicker BJ. In rodent models, a single dose of azithromycin was more effective than dosing split over 3 or 5 days. Washington, DC: 44th ICAAC; October 30-November 2, 2004.
33. Sutcliffe J, Grebe T, Tait-Kamradt A, et al. Detection of erythromycin-resistant determinants by PCR. Antimicrob Agents Chemother. 1996;40: 2562-2566.
34. Davies BI, Maesen FP. Clinical effectiveness of levofloxacin in patients with acute purulent exacerbations of chronic bronchitis: the relationship with in-vitro activity. J Antimicrob Chemother. 1999; 43(suppl C):83-90.
35. Weiss LR. Open-label, randomized comparison of the efficacy and tolerability of clarithromycin, levofloxacin, and cefuroxime axetil in the treatment of adults with acute bacterial exacerbations of chronic bronchitis. Clin Ther. 2002;24:1414-1425.
36. DeAbate C, Russell M, McElvaine P, et al. Safety and efficacy of oral levofloxacin versus cefuroxime axetil in acute bacterial exacerbation of chronic bronchitis. Respir Care. 1997;42:206-213.
37. Kardas P. Patient compliance with antibiotic treatment for respiratory tract infections. J Antimicrob Chemother. 2002;49:897-903.
38. Halpern MT, Higashi MK, Bakst AW, et al. The economic impact of acute exacerbations of chronic bronchitis in the United States and Canada: a literature review. J Manag Care Pharm. 2003;9:353-359.
39. Pichichero ME. Short course antibiotic therapy for respiratory infections: a review of the evidence. Pediatr Infect Dis J. 2000;19: 929-937.
40. FDA. Labelling Requirements for Systemic Antibacterial Drug Products Intended for Human use. Available at: http://www.fda.gov/oc/opacom/hottopics/ anti_resist.html. Accessed June 28, 2004.
41. Chen DK, McGeer A, de Azavedo JC, et al. Decreased susceptibility of Streptococcus pneumoniae to fluoroquinolones in Canada. Canadian Bacterial Surveillance Network. N Engl J Med. 1999;341: 233-239.
42. Zervos MJ, Hershberger E, Nicolau DP, et al. Relationship between fluoroquinolone use and changes in susceptibility to fluoroquinolones of selected pathogens in 10 United States teaching hospitals, 1991-2000. Clin Infect Dis. 2003;37:1643-1648.