Abstract

The efficacy and safety of Cefetamet pivoxil in the treatment of community-acquired pneumonia in children were assessed in an open, randomised, comparative multicentre study in which 260 children (in- and outpatients) with either bacterial pneumonia (n = 170) or bronchopneumonia (n = 90) were enrolled. Cefetamet pivoxil, an oral third generation Cephalosporin, was administered to 85 children at a dosage of 10 mg/kg twice daily, the recommended therapeutic dosage, and to 94 children at a dosage of 20 mg/kg twice daily. Cefaclor was administered to 81 children at a dosage of 10 mg/kg three times daily. The duration of treatment was 7 days. Assessments were performed on days 0, 3, 7 and 14 after initiation of treatment. Clinical signs and symptoms began to improve soon after the start of treatment, and continued to improve in all 3 treatment groups. The therapeutic outcome was considered successful in 80 of the 81 assessable patients receiving Cefetamet pivoxil 10 mg/kg twice daily (98.8%), in 79 of the 81 assessable patients receiving Cefetamet pivoxil 20 mg/kg twice daily (97.6%), and in 71 of the 75 assessable patients receiving Cefaclor 10 mg/kg three times daily (94.7%). The differences in outcome between the 3 groups were not statistically significant. Adverse events were of gastrointestinal origin (mainly diarrhoea, nausea, and/or vomiting), and occurred with similar frequencies in the groups treated with Cefetamet pivoxil 10 mg/kg twice daily and Cefaclor 10 mg/kg three times daily. Cefetamet pivoxil administered at the standard dosage of 10 mg/kg twice daily was effective and well tolerated in children with bacterial pneumonia or bronchopneumonia. The twice-daily Cefetamet pivoxil dose schedule compares favourably with the well-established Cefaclor 3-times-daily regimen and may result in improved compliance.

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