[Basic and clinical studies on imipenem/cilastatin sodium in the pediatric field]
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Imipenem/cilastatin sodium (MK-0787/MK-0791) demonstrates potent antibacterial activity against pediatric S. aureus and E. coli. This antibiotic proved safe and 100% effective in treating pediatric bacterial infections with minimal side effects.
Area of Science:
- Pediatric Infectious Diseases
- Clinical Pharmacology
- Antimicrobial Agents
Background:
- Imipenem/cilastatin sodium (MK-0787/MK-0791) is a carbapenem antibiotic.
- Pediatric infections require effective and safe therapeutic options.
Purpose of the Study:
- To evaluate the antibacterial activity and pharmacokinetics of imipenem/cilastatin sodium in pediatric patients.
- To assess the clinical efficacy and safety of imipenem/cilastatin sodium for treating pediatric bacterial infections.
Main Methods:
- In vitro susceptibility testing against clinical isolates of Staphylococcus aureus and Escherichia coli.
- Pharmacokinetic analysis of imipenem/cilastatin sodium at two dosage levels (10 mg/10 mg/kg and 20 mg/20 mg/kg).
- Clinical trial involving 13 pediatric patients with bacterial infections.
Main Results:
- Imipenem/cilastatin sodium exhibited low minimum inhibitory concentrations (MICs) against S. aureus (≤0.10 µg/mL) and E. coli (≤0.39 µg/mL).
- Achieved peak serum levels of 38.6 µg/mL and 36.2 µg/mL, with serum half-lives of 0.8-0.9 hours.
- Demonstrated 100% clinical efficacy with good or excellent outcomes in all 13 pediatric patients, with diarrhea as the most common side effect.
Conclusions:
- Imipenem/cilastatin sodium is a safe and highly effective antimicrobial agent for pediatric bacterial infections.
- The pharmacokinetic profile supports its use in pediatric populations.
- Further investigation into potential adverse events is warranted.
Abstract:
Basic and clinical studies have been performed on imipenem/cilastatin sodium (MK-0787/MK-0791) in the pediatric field. Antibacterial activities of MK-0787 against 14 clinical isolates of S. aureus and 67 isolates of E. coli were determined. The MIC of MK-0787 was 0.10 microgram/ml or less against all 14 strains of S. aureus. The MIC of MK-0787 was 0.39 microgram/ml or less against all 67 strains of E. coli. The pharmacokinetics of MK-0787/MK-0791 was studied at dose levels of 10 mg/10 mg/kg and 20 mg/20 mg/kg. The peak serum levels of MK-0787 achieved approximately 1 hour after the administration of 10 mg/10 mg/kg and 20 mg/20 mg/kg doses were 38.6 micrograms/ml and 36.2 micrograms/ml, respectively. The serum half-lives were 0.8 hour and 0.9 hour, respectively. The total 6-hour urinary excretions were 82.1% and 66.7%, respectively. The MK-0787/MK-0791 was administered to 13 children with bacterial infections. The clinical results were excellent or good in all cases. The overall efficacy rate was 100%. As a side effect, diarrhea was observed in 1 patient. Abnormalities in laboratory findings observed were elevation of direct bilirubin in 1 patient, thrombocytosis in 2, and a prolonged prothrombin time in 1 patient. Based on the above results, it can be concluded that MK-0787/MK-0791 is a safe and effective drug to use for the treatment of pediatric infections.