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[Evaluation of imipenem/cilastatin sodium in neonatal infections]
K E Okura1, T Haruta, T Kanamoto
1Department of Pediatrics, Kobe Central Municipal Hospital.
Insights
Imipenem/cilastatin sodium effectively treated infections in neonates and infants, showing excellent or good clinical responses and eradicating all bacterial isolates. Side effects were mild and transient.
Area of Science:
- Pharmacology and Therapeutics
- Pediatric Infectious Diseases
- Antimicrobial Agents
Context:
- Infections in neonates and infants pose significant clinical challenges.
- Limited data exists on the efficacy and safety of specific antimicrobial regimens in this population.
- Imipenem/cilastatin sodium is a broad-spectrum antibiotic combination.
Purpose:
- To evaluate the clinical efficacy and safety of imipenem/cilastatin sodium in pediatric patients with various infections.
- To determine plasma and cerebrospinal fluid concentrations of imipenem/cilastatin sodium.
- To assess the microbiological eradication rates of causative pathogens.
Summary:
- Ten pediatric patients (8 neonates, 2 infants) received intravenous imipenem/cilastatin sodium (IPM/CS) b.i.d. or t.i.d.
- Clinical efficacy was assessed in 9 patients with pneumonia, UTI, omphalitis, suspected meningitis, periproctal abscess, and suspected septicemia, with 4 excellent and 5 good responses.
- All 6 bacterial isolates, including Staphylococcus aureus, Escherichia coli, Enterococcus faecalis, Streptococcus agalactiae, and Bacteroides fragilis, were eradicated. Mild side effects like rash and transient laboratory abnormalities were noted.
Impact:
- Imipenem/cilastatin sodium demonstrates significant clinical effectiveness and microbiological eradication in pediatric infections.
- The study provides valuable pharmacokinetic and safety data for imipenem/cilastatin sodium use in neonates and infants.
- Findings support the use of imipenem/cilastatin sodium as a therapeutic option for severe pediatric bacterial infections.
Abstract:
Ten patients with infections (8 neonates and 2 infants) were treated with 10.2 mg/10.2 mg/kg-37.7 mg/37.7 mg/kg of imipenem/cilastatin sodium (IPM/CS) b.i.d. or t.i.d. by a 1-hour intravenous drip infusion. The plasma concentrations of IPM/CS were determined in 5 of the 10 patients and in the cerebrospinal fluid of 1 patient of the 5. 1. The patients studied included 5 with pneumonia and 1 each with urinary tract infection, omphalitis, suspected meningitis, periproctal abscess and suspected septicemia. Clinical efficacy was evaluated in 9 patients: the patient with suspected meningitis was excluded from the clinical evaluation because the infection was doubtfully due to bacteria. Responses were excellent in 4 and good in 5 patients. No patient with a poor response was observed. All of the 6 etiological isolates obtained from 5 patients (2 strains of Staphylococcus aureus and 1 each of Escherichia coli, Enterococcus faecalis, Streptococcus agalactiae and Bacteroides fragilis) were eradicated. 2. As for side effects, rash was observed in 1 patient and petechiae accompanied by decreases in platelets and reticulocytes and increases in GOT and GPT were observed in another. Other abnormal laboratory test values in addition to the above abnormalities consisted of an increase in GPT in 1 patient and increases in GOT and GPT in another. These side effects and abnormalities in laboratory test values were mild and normalized after discontinuation or completion of IPM/CS administration.(ABSTRACT TRUNCATED AT 250 WORDS)