Azithromycin versus cefaclor in the treatment of acute bacterial pneumonia
- 129 Downloads
In this randomised, double-blind study carried out in 28 centres, azithromycin (500 mg single dose on day 1, followed by 250 mg once-daily on days 2–5) was compared with cefaclor (500 mg t.i.d. for 10 days) in the treatment of acute bacterial pneumonia. A total of 119 patients entered the study, and of these 71 were evaluable and included in the efficacy analysis. The overall satisfactory clinical response was 97.3 % for azithromycin patients and 100 % for cefaclor patients. The clinical cure rates of azithromycin and cefaclor were 46.9 % and 41.0 %, respectively; improvement was seen in an additional 46.9 % of azithromycin-treated patients and in 59.0 % of the cefaclor group. The bacteriological eradication rates were 80.4 % and 92.6 %, respectively. These rates of clinical and bacteriological efficacy, were not statistically different. Both antibiotics were well tolerated during the study; only two patients (one on each study drug) discontinued medication due to adverse events. The overall incidence of side effects was 18.9 % (10 of 53 patients) for azithromycin- and 12.1 % (eight of 66 patients) for cefaclor-treated patients. Gastrointestinal disturbances were the most commonly reported side effects (nine of 10 azithromycin-treated patients and six of eight cefaclor-treated patients). In addition, two cefaclor patients reported headache. All azithromycin side effects were mild or moderate in severity, but there were two severe occurrences in the cefaclor group (1 nausea, 1 vomiting) the later leading to discontinuation. In conclusion, the study demonstrated that a five-day (five-dose) course of therapy with azithromycin was effective and well tolerated compared with a 10-day (30-dose) course of cefaclor in the treatment of patients with acute bacterial pneumonia.
Unable to display preview. Download preview PDF.
- 1.Bright GM, Nagel AA, Bordner J, Desai KA, Dibring JN, Nowakowska J, Vincent L, Watrous RM, Sciavolino FC: Synthesis, in vitro and in vivo activity of novel 9-deoxo-9a-aza-9a homoerythromycin A derivatives: a new class of macrolides, the azalides. Journal of Antibiotics 1988, 41: 1029–1047.PubMedGoogle Scholar
- 2.Girard AE, Girard D, English AR, Gootz TD, Cimochowski CR, Faiella JA, Haskell SL, Retsema JA: Pharmacokinetic and in vivo studies with azithromycin (CP-62,993), a new macrolide with extended half life and excellent tissue distribution. Antimicrobial Agents and Chemotherapy 1987, 31: 1948–1954.PubMedGoogle Scholar
- 3.Foulds G, Shepard RM, Johnson RB: The pharmacokinetics of azithromycin in human serum and tissues. Journal of Antimicrobial Chemotherapy 1990, 25, Supplement A: 73–82.Google Scholar
- 6.Retsema J, Girard A, Shelkly W, Manousos M, Anderson M, Bright G, Borovoy R, Brennan L, Mason R: Spectrum and mode of action of azithromycin (CP-62,993), a new 15-membered-ring macrolide with improved potency against gram-negative organisms. Antimicrobial Agents and Chemotherapy 1987, 31: 1939–1947.PubMedGoogle Scholar
- 8.Girard AE, Girard D, English AR, Gootz TD, Cimochowski CR, Faiella JA, Haskell SL, Retsema JA: Pharmacokinetic and in vivo studies with azithromycin (CP-62,993), a new macrolide with an extended half-life and excellent tissue distribution. Antimicrobial Agents and Chemotherapy 1987, 31: 1948–1954.PubMedGoogle Scholar
- 9.Retsema JA, Girard AE, Girard D, Milisen WB: Relationship of high tissue concentrations of azithromycin to bactericidal activity and efficacy in vivo. Journal of Antimicrobial Chemotherapy 1990, 25, Supplement A: 83–89.Google Scholar
- 10.Balmes R, Clerc G, Dupont B, Labram C, Pariente R, Poirier R: A comparative study of azithromycin and amoxicillin in the treatment of lower respiratory tract infections. European Journal of Clinical Microbiology and Infectious Diseases 1990, 10: 437–439.Google Scholar