Azithromycin versus cefaclor in the treatment of acute exacerbations of chronic obstructive pulmonary disease

Abstract

An open-label, randomized, multicenter study compared the efficacy and safety of once-daily azithromycin (500-mg dose on day 1 followed by 250 mg once daily on days 2 to 5) with those of cefaclor (500 mg three times daily for 10 days) in the treatment of lower respiratory tract infections. Two hundred one patients with acute bacterial exacerbations of chronic obstructive pulmonary disease (COPD) entered the study; 136 were treated with azithromycin and 65 with cefaclor. Sixty-four azithromycin-treated patients and 25 cefaclor-treated patients were evaluable for efficacy analysis. All patients (100%) in the azithromycin group achieved a successful clinical outcome (cure or improvement) compared with 23 of 25 (92.0%) patients in the cefaclor group. The difference between the two treatment groups was not statistically significant. Bacterial eradication of 75 of 86 (87.2%) isolates was achieved with azithromycin, compared with an eradication rate of 27 of 30 (90.0%) isolates with cefaclor. Haemophilus influenzae was eradicated by azithromycin in 19 of 21 (90.5%) patients and by cefaclor in six of nine (67.7%) patients. Streptococcus pneumoniae was successfully eradicated in all patients in both treatment groups (nine patients treated with azithromycin and four patients treated with cefaclor). There were no statistically significant differences in eradication rates between the two treatment groups. Both antibiotics were well tolerated; the incidence of side effects was similar for azithromycin and cefaclor, and only minor abnormalities in laboratory screening tests were noted in both treatment groups. In conclusion, once-daily azithromycin for 5 days is as effective and as well tolerated as three-times-daily cefaclor for 10 days in the treatment of patients with acute bacterial exacerbations of COPD.