A total of 371 children, aged 6 months to 12 years, with acute otitis media, acute sinusitis, streptococcal tonsillitis/pharyngitis, or pneumonia were included in an open, multicenter study. Among them, 192 children were randomized to receive azithromycin for 3 days (10 mg/kg daily), and 179 for 5 days (10 mg/kg on day 1 and 5 mg/kg on days 2-5). The overall clinical cure rate was 95.7% and 96.1%, and bacteriological eradication rate 90.1% and 94.2% in the 3-day and 5-day groups, respectively. Side effects, mostly mild gastrointestinal disturbances, were observed in 5.3% of children from the 3-day, and 6.7% from the 5-day group. Only in one child (0.3%) was therapy discontinued due to vomiting. The results of this study demonstrate that 3-day and 5-day azithromycin courses have comparable efficacy and tolerability in children with respiratory infections.
An open, randomized, multicentre study compared the efficacy and safety of 3-day azithromycin with 10-day roxithromycin for the treatment of atypical pneumonia. Azithromycin was administered 500 mg once daily to 90 and roxithromycin 150 mg bid to 60 patients. Causative pathogens were identified by serological methods. In the azithromycin treatment group, Mycoplasma pneumoniae was identified in 65, Chlamydia spp. in 9 and Coxiella burnetti in 1 patient. In the roxithromycin treatment group, M. pneumoniae was identified in 39, Chlamydia spp. in 9 and C. burnetti in 3 patients. 89 azithromycin and 53 roxithromycin patients were eligible for efficacy analysis. Clinical cure rate was 98.9% in the azithromycin and 94.3% in the roxithromycin treatment group. Adverse events were observed in 3 patients in each group. Azithromycin appears to be as effective as roxithromycin for the treatment of atypical pneumonia. The 3-day azithromycin regimen may offer an additional advantage over 10-day roxithromycin by virtue of its more convenient administration.
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