WORLDWIDE PEDIATRIC EXPERIENCE WITH LOW-DOSE SULTAMICILLIN ORAL SUSPENSION

A total of 431 pediatric patients (233 boys [54%] and 198 girls [46%]) between the ages of 3 months and 16 years, with a diagnosis of upper or tower respiratory tract infections or skin and soft tissue infections, entered this international pediatric clinical program conducted by 14 investigators in nine countries in North, Central, and South Americas; Asia; and Europe. After informed consent was obtained from parents or legal guardians, all children were treated as outpatients and were to receive a daily dose of 25-mg/kg sultamicillin oral suspension, administered as two equally divided doses 12 hours apart. Four hundred eight children met all requirements for clinical efficacy evaluability and were included in the drug clinical efficacy assessment; 146 were both clinically and bacteriologically evaluable for efficacy. Three hundred eighty-two patients (94%) were reported as clinically cured, 15 (4%) as improved, and 11 (3%) as clinical failures. The bacteriologic eradication rate was 99%, or 153 of 155 isolated pathogens, including 38 of 39 beta-lactamase-producing strains. All 431 patients were evaluable for safety; 34 (8%) experienced 39 adverse drug reactions that were considered by the investigators to be drug-related or possibly drug-related. As expected with a beta-lactam antibiotic, side effects were mainly gastrointestinal in nature. The most frequent, diarrhea, was reported in 26 patients (6%). Drug discontinuation occurred in 9 patients (2%). Few loboratory abnormalities of potential clinical significance were recorded in any of the treated children. Sultamicillin pediatric suspension, administered orally twice daily at a dose of 25 mg/kg, confirms its efficacy and toleration in the treatment of mild-to-moderate bacterial pediatric infections.