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[Pharmacokinetic and clinical studies on sulbactam/ampicillin in children]
K Hattori1, H Higashino, T Kobayashi
1Department of Pediatrics, Kansai Medical University.
Insights
Sulbactam/ampicillin (SBT/ABPC) demonstrates superior antibacterial activity against resistant organisms in children. This combination antibiotic showed high clinical efficacy in treating various pediatric infections with minimal adverse effects.
Area of Science:
- Pediatric Infectious Diseases
- Pharmacology
- Microbiology
Context:
- Antibiotic resistance is a growing concern in pediatric infections.
- Beta-lactamase producing bacteria pose a significant challenge to traditional antibiotic therapies.
- Sulbactam/ampicillin (SBT/ABPC) is a combination antibiotic used to combat bacterial infections.
Purpose:
- To evaluate the antibacterial efficacy of sulbactam/ampicillin (SBT/ABPC) in pediatric patients.
- To assess the pharmacokinetic properties of SBT/ABPC, including absorption and urinary excretion.
- To determine the clinical effectiveness and safety profile of SBT/ABPC in treating various pediatric infections.
Summary:
- SBT/ABPC exhibited enhanced Minimum Inhibitory Concentrations (MICs) against beta-lactamase producing and ampicillin-resistant organisms compared to ampicillin alone.
- Pharmacokinetic studies showed favorable serum levels and urinary excretion rates for both sulbactam and ampicillin.
- Clinical trials in 24 children demonstrated an overall efficacy rate of 86.4% for SBT/ABPC in treating pneumonia, respiratory tract infections, and urinary tract infections, with a low incidence of mild adverse effects.
Impact:
- SBT/ABPC offers a valuable therapeutic option for treating resistant bacterial infections in children.
- The study supports the use of SBT/ABPC in pediatric settings, contributing to antimicrobial stewardship.
- Findings provide evidence for the effectiveness and safety of SBT/ABPC, guiding clinical practice in pediatric infectious disease management.
Abstract:
Laboratory and clinical studies of sulbactam/ampicillin (SBT/ABPC) in children have been carried out, and the following results were obtained. 1. Antibacterial effect MICs of SBT/ABPC were only one-tube less than or similar to those of ABPC against susceptible organisms. Against ABPC-resistant organisms at the inoculum size of 10(8) cells/ml however, SBT/ABPC was superior to ABPC when evaluated in terms of their MIC values. When MICs of SBT/ABPC were compared to those of ABPC against organisms with high beta-lactamase producing activities, it was found that many of ABPC-resistant organisms were much susceptible to SBT/ABPC. 2. Absorption and urinary excretion In 2 cases to which 50 mg/kg and 20 mg/kg SBT/ABPC were respectively given over 30 minutes by drip infusion, peak serum levels were obtained at the end of the drip infusion with peak levels of SBT of 45.5 micrograms/ml, 12.5 micrograms/ml, respectively and those of ABPC of 83.0 micrograms/ml, 22.9 micrograms/ml, respectively. The half-lives of SBT and ABPC were 0.94 hour and 0.98 hour, respectively. The mean urinary excretion rates in the first 6 hours after the end of administration were 84.4% for SBT and 63.1% for ABPC. 3. Clinical results Clinical efficacies were evaluated in 24 cases including 9 cases of pneumonia, 2 cases of upper respiratory infection, 7 cases of urinary tract infection and 1 case each of bronchopneumonia, pyothorax, tonsillitis, streptococcal infection, ++ phlegmon and staphylococcal scalded skin syndrome. Clinical efficacies were excellent or good in 19 cases with an overall efficacy rate of 86.4%. Adverse effect was found in 1 case with nausea and vomiting, and abnormal laboratory test values observed were 2 cases each of eosinophilia, slight elevation of GOT and GPT and elevation of LDH, but they were not serious.