Efficacy and safety of azithromycin vs levofloxacin in the outpatient treatment of acute bacterial exacerbations of chronic bronchitis.
OBJECTIVE
To compare the safety and efficacy of oral azithromycin and levofloxacin in the treatment of outpatients with acute bacterial exacerbations of chronic bronchitis (ABECB).


METHODS
Randomized, double-blinded, double-dummy, multicenter trial with 1:1 treatment allocation.


METHODS
Outpatient treatment setting.


METHODS
Two hundred thirty-five male or female outpatients between the ages of 35 and 75 years who had received a clinical diagnosis of ABECB.


METHODS
Blinded treatment with either oral azithromycin, 500 mg on day 1 and 250 mg per day for days 2 to 5, or, oral levofloxacin, 500 mg q24h for 7 days.


RESULTS
Both treatments were well-tolerated, with the majority of adverse events being GI in nature. Favorable clinical outcomes in clinically evaluable patients were demonstrated in 89% of patients receiving azithromycin and in 92% of patients receiving levofloxacin by day 4 of therapy. At day 24, the posttherapy visit, favorable responses were approximately 82% and 86%, respectively, for patients in the two treatment groups. The bacterial eradication rates of respiratory pathogens were 96% for azithromycin and 85% for levofloxacin.


CONCLUSIONS
Despite increasing concerns over macrolide resistance and a higher incidence of Gram-negative pathogens, a standard 5-day course of oral azithromycin was clinically and bacteriologically equivalent to a 7-day course of oral levofloxacin in the treatment of patients with ABECB.
Amsden
Guy W
GW
Clinical Pharmacology Research Center and Department of Adult and Pediatric Medicine, Bassett Healthcare, Cooperstown, NY 13326, USA. guy.amsden@bassett.org
Baird
Ian M
IM
Simon
Stuart
S
Treadway
Glenda
G
D000208:Acute Disease; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D000890:Anti-Infective Agents / Q000627:therapeutic use*; D017963:Azithromycin / Q000627:therapeutic use*; D001424:Bacterial Infections / Q000188:drug therapy*; D029481:Bronchitis, Chronic / Q000382:microbiology*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D064704:Levofloxacin; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D015242:Ofloxacin / Q000627:therapeutic use*
D000900:Anti-Bacterial Agents; D000890:Anti-Infective Agents; D064704:Levofloxacin; D017963:Azithromycin; D015242:Ofloxacin