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Clinico-pharmacological studies of sisomicin in ill children
Insights
Sisomicin effectively treated serious bacterial infections in pediatric patients, achieving high cure rates. While generally well-tolerated, reversible nephrotoxicity was observed in one case with prolonged use.
Area of Science:
- Pediatric Infectious Diseases
- Pharmacology
- Clinical Therapeutics
Background:
- Serious bacterial infections pose significant risks in hospitalized infants, children, and adolescents.
- Aminoglycoside antibiotics are crucial for treating severe bacterial infections.
- Sisomicin is an aminoglycoside antibiotic with potential therapeutic applications.
Purpose of the Study:
- To evaluate the efficacy and safety of sisomicin in treating serious bacterial infections in pediatric patients.
- To determine the pharmacokinetic profile of sisomicin in children and adolescents.
- To assess the tolerability and identify potential adverse effects of sisomicin therapy.
Main Methods:
- Prospective study involving hospitalized infants, children, and adolescents with serious bacterial infections.
- Sisomicin administered at a dosage of 4.5 mg/kg per day.
- Clinical and bacteriological outcomes were assessed, along with serum concentrations and urinary excretion.
Main Results:
- Ten out of eleven children achieved clinical cures, and nine achieved bacteriological cures.
- Mean sisomicin half-life was 98.3 minutes; peak serum concentrations ranged from 5 to 6 mug/ml.
- One patient developed reversible nephrotoxicity during prolonged therapy (26 days).
Conclusions:
- Sisomicin demonstrates significant efficacy in treating serious bacterial infections in pediatric populations.
- The drug is generally well-tolerated, with reversible nephrotoxicity being a potential concern with extended treatment durations.
- Further investigation into optimal dosing and monitoring for pediatric patients is warranted.
Abstract:
Sisomicin, at 4.5 mg/kg per day, was prescribed for the therapy of serious bacterial infections of hospitalized infants, children, and adolescents. Eleven children received full treatment courses, with 10 clinical and 9 bacteriological cures. Three patients with underlying disease (two cystic fibrosis and one aplastic anemia) accounted for the failures. Mean half-life was 98.3 min (range, 26.1 to 159.3), and peak serum concentrations 10 min after intravenous infusion were similar (5 to 6 mug/ml) on days 1, 3, and 5 of therapy. Mean urinary concentrations were 54.3 mug/ml; 31 to 47% of the drug was excreted within the 8-h dosage interval. The drug was tolerated well by all patients; however, one patient, receiving the longest duration of therapy (26 days), developed reversible nephrotoxicity.