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[Clinical, bacteriological and pharmacokinetic study of Sisomicin in the newborn infant]
Insights
Sisomicin demonstrated effectiveness and good tolerance in treating severe pediatric bacterial infections, especially when combined with beta-lactam antibiotics. Dosing recommendations were established for newborns and infants.
Area of Science:
- Pediatric Infectious Diseases
- Pharmacology
- Bacteriology
Context:
- Severe bacterial infections in children require effective and safe therapeutic options.
- Aminoglycoside antibiotics, like sisomicin, are crucial for treating serious Gram-negative bacterial infections.
- Understanding drug pharmacokinetics and tolerance is vital for optimizing pediatric treatment regimens.
Purpose:
- To evaluate the clinical efficacy and safety of sisomicin in pediatric patients with severe bacterial infections.
- To determine the pharmacokinetic profile, including half-life and potential accumulation, of intramuscularly administered sisomicin in neonates and infants.
- To assess the in vitro susceptibility of various bacterial strains to sisomicin.
Summary:
- Sisomicin showed significant efficiency in treating severe bacterial infections in 19 children, particularly when administered concurrently with beta-lactam antibiotics.
- The study found good local and systemic tolerance to sisomicin.
- Intramuscular sisomicin exhibited half-lives of 4.0 ± 1.8 hours in neonates (<10 days) and 2.0 ± 0.3 hours in older infants (creatininemia <10 mg/L), with no observed accumulation.
- Recommended daily intramuscular doses are 3-6 mg/kg, divided every 8 hours for infants and every 12 hours for newborns.
Impact:
- Provides evidence supporting the use of sisomicin as a safe and effective treatment for severe pediatric bacterial infections.
- Establishes pharmacokinetic data and dosing guidelines for sisomicin in pediatric populations, aiding clinicians in safe and effective drug administration.
- Contributes to the understanding of bacterial susceptibility patterns relevant to aminoglycoside therapy.
Abstract:
A study of the efficiency and tolerance of sisomicin in 19 children with severe bacterial infections led to the following conclusions: -sisomicin was efficient, particularly in association with beta-lactamin; -the local and systemic tolerance was good. The susceptibility of various bacterial strains was studied. The half-life of sisomicin given intramuscularly was : 4,0 +/- 1,8 hours in the new-borns under 10 days and 2,0 +/- 0,3 hours in older infants, when creatininemia was below 10 mg/l. No accumulation was found. The recommended daily dose of sisomicin by intramuscular route is 3 to 6 mg/kg, i.e. 1 to 2 mg every 8 hours in infants an 1,5 to 3 mg every 12 hours in new-borns.