A prospective multi-center randomized parallel study on efficacy and safety of cefaclor vs.amoxicillin-clavulanate in children with acute bacterial infection of lower respiratory tract

ObjectiveTo evaluate the efficacy and safety of cefaclor Ready to Use(RTU) vs.amoxicillin-clavulanate(4∶1) in treating acute bacterial infection of lower respiratory tract in children.MethodsA multi-center prospective randomized controlled single-blind study was performed from September 2001 to September 2002 to compare cefaclor with amoxicillin-clavulanate in 220 patients with bacterial lower respiratory tract infections.One hundred and ten(110) children were treated with cefaclor(40 mg·kg~(-1)·d~(-1)),and the other 110 were treated with amoxicillin-clavulanate(45 mg·kg~(-1)·d~(-1)).These agents were given orally in two divided doses daily for 10 days.Patients were evaluated before,during and after therapy.ResultsOf the 220 patients,acute bronchitis was diagnosed in 135 patients(65 in cefaclor group;70 in amoxicillin-clavulanate group),acute pneumonia was identified in 85 patients(45 in cefaclor group;40 in amoxicillin-clavulanate group).The treatment response was favorable in both groups.The overall efficacy rates of cefaclor and amoxicillin-clavulanate were 85.5%(95% CI 78.9%-92.0%) and 82.7%(95% CI 75.7%-89.8%) respectively(P=0.580).The bacterial pathogen was identified in 55.9% of the patients.The leading pathogens were H.influenzae,S.pneumoniae and M.catarrhalis.The bacterial eradication rate was(70.7%)and 70.8% respectively in the two treatment groups(P=1.000).The compliance rate was high(95.0% vs.90.8%).The adverse events in the two groups were mainly nausea and vomiting(1.8% vs.2.7%),abdominal pain(2.7% vs.3.6%) and diarrhea(6.4% vs.9.1%).All of these were mild and resolved during therapy.ConclusionsBoth cefaclor RTU and amoxicillin-clavulanate are still effective and safe in treating bacterial infections of lower respiratory tract infection in children.