An open, multicentre, comparative study of the efficacy and safety of azithromycin and co-amoxiclav in the treatment of upper and lower respiratory tract infections in children. The Paediatric Azithromycin Study Group.
An open prospective, multicentre, comparative, randomized (2:1) study was conducted in 481 children diagnosed as having mild-to-moderate lower respiratory tract infections. The efficacy and safety of azithromycin suspension (10 mg/kg), dosed orally once daily for 3 days, was compared with that of co-amoxiclav (10 mg/kg in a 4:1 ratio), dosed orally three times daily for 5-10 days. The proportion of evaluable patients (n = 472) showing a cure or improvement was significantly higher in the azithromycin group (96.8%) than in the co-amoxiclav group (91%, P = 0.0199). There were six relapses in both groups, giving an overall response rate of 95% for azithromycin versus 87.1% for co-amoxiclav (P = 0.0025). Adverse events were reported in 10% of the patients treated with azithromycin, and 11.3% of co-amoxiclav patients. Reported and counted compliance was significantly better in the azithromycin group. A 3-day regimen of azithromycin was as effective and as safe as a 5-10 day regimen of co-amoxiclav in the treatment of respiratory tract infections in children, and compliance was improved.
Lauvau
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DV
Clinique Inter-universitaire Ambroise Paré, Mons, Belgium.
Verbist
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D000293:Adolescent; D000367:Age Factors; D019980:Amoxicillin-Potassium Clavulanate Combination / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D017963:Azithromycin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001419:Bacteria / Q000187:drug effects; D001424:Bacterial Infections / Q000188:drug therapy; D001835:Body Weight; D002648:Child; D002675:Child, Preschool; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D010349:Patient Compliance; D011446:Prospective Studies; D012141:Respiratory Tract Infections / Q000175:diagnosis / Q000188:drug therapy* / Q000382:microbiology; D013997:Time Factors; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D019980:Amoxicillin-Potassium Clavulanate Combination; D017963:Azithromycin