[Clinical studies on sultamicillin fine granule in pediatric field]
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J Ishikawa1, K Kida, H Matsuda
1Department of Pediatrics, School of Medicine, Ehime University.
Insights
Sultamicillin (SBTPC) fine granule demonstrated 100% clinical and bacteriological efficacy in children with bacterial infections. This safe antibiotic is a top choice for pediatric infections.
Area of Science:
- Pediatric infectious diseases
- Antibiotic pharmacokinetics and efficacy
- Bacteriology
Context:
- Bacterial infections are common in children, necessitating effective and safe antibiotic treatments.
- Evaluating new formulations of existing antibiotics is crucial for improving pediatric care.
- Sultamicillin, a combination antibiotic, offers a broad spectrum of activity.
Purpose:
- To assess the pharmacokinetics, safety, and efficacy of sultamicillin (SBTPC) fine granule in pediatric patients.
- To determine the clinical and bacteriological outcomes of SBTPC treatment for various childhood infections.
- To compare the in vitro activity of SBTPC with other common antibiotics.
Summary:
- Pharmacokinetic analysis showed ampicillin half-life of 1.38 hours and sulbactam half-life of 0.93 hours in children.
- A 100% clinical efficacy rate was observed in 14 children treated for tonsillitis, pharyngitis, bronchitis, cystitis, scarlet fever, and cellulitis.
- Bacteriological eradication was 100% in 5 children, with SBTPC showing superior activity against resistant strains compared to ampicillin and comparable or better activity than cephalexin/cefaclor.
- The only adverse event was eosinophilia in 2 children; no significant side effects were reported.
Impact:
- Sultamicillin (SBTPC) fine granule is a safe and effective antibiotic option for treating pediatric bacterial infections.
- The study supports the use of SBTPC fine granule as a first-choice antibiotic in pediatric infectious disease management.
- Findings contribute to evidence-based guidelines for antibiotic selection in children.
Abstract:
Pharmacokinetics, safety and effects on bacterial infection of sultamicillin (SBTPC) fine granule were evaluated in 17 children. The results obtained are summarized as follows. 1. Pharmacokinetics in 3 children receiving a single dose of 10 mg per kg body weight were evaluated. The half-life of ampicillin (ABPC) was 1.38 +/- 0.14 hours and that of sulbactam was 0.93 +/- 0.26 hour. 2. Fourteen cases, including 7 tonsillitis, 2 pharyngitis, 2 bronchitis, and 1 each of cystitis, scarlet fever and cellulitis were treated with SBTPC fine granule. The clinical efficacy rate was 100%. 3. Bacteriological efficacies classified by causative organisms were evaluated in 5 children. Staphylococcus aureus was responsible in 3 cases, Streptococcus pyogenes in 1 case, Escherichia coli and Proteus mirabilis in 1 case. Eradication rate was 100%. SBTPC was more active than ABPC against ABPC-resistant strains and almost equal to or more active than cephalexin or cefaclor. 4. The only abnormal laboratory test value observed was eosinophilia in 2 children. No side effects were recorded. From the above results it is concluded that SBTPC fine granule is one of first choices of effective, useful and safe antibiotics for the treatment of infections in pediatric field.