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Gentamicin once-daily versus thrice-daily in children
K Elhanan1, L Siplovich, R Raz
1Department of Pediatrics A, Central Emek Hospital, Afula, Israel.
Insights
Gentamicin administered once daily showed similar clinical outcomes to thrice-daily dosing in children with Gram-negative infections. This once-daily regimen achieved higher peak concentrations and comparable cure rates with minimal toxicity.
Area of Science:
- Pediatric Infectious Diseases
- Pharmacokinetics and Pharmacodynamics
- Antimicrobial Therapy
Background:
- Gram-negative bacterial infections pose a significant threat to pediatric populations.
- Optimizing antibiotic dosing regimens is crucial for efficacy and safety in children.
- Gentamicin is a commonly used aminoglycoside antibiotic for severe bacterial infections.
Purpose of the Study:
- To compare the efficacy and safety of once-daily versus thrice-daily gentamicin administration in children.
- To evaluate the pharmacokinetic profile, including peak and trough concentrations, of different gentamicin dosing frequencies.
- To assess clinical and microbiological cure rates and potential adverse effects like nephrotoxicity and ototoxicity.
Main Methods:
- An open-label, randomized study involving 50 children (3 months to 16 years) with Gram-negative bacterial infections.
- Participants were randomized to receive gentamicin 4.5 mg/kg/day either once daily (od) or in three divided doses (tds).
- Serum gentamicin concentrations (peak and trough), clinical cure, microbiological cure, and toxicity were assessed.
Main Results:
- Once-daily gentamicin resulted in significantly higher peak concentrations and lower trough concentrations compared to thrice-daily dosing.
- Clinical cure rates were high and similar in both groups: 88.8% for once-daily and 91% for thrice-daily.
- Microbiological cure rates were also comparable (100% vs. 92%), with no observed nephrotoxicity and two cases of ototoxicity in each group.
Conclusions:
- Once-daily administration of gentamicin at 4.5 mg/kg/day is a viable and effective option for treating Gram-negative bacterial infections in children.
- The dosing regimen impacts gentamicin pharmacokinetics, but both once-daily and thrice-daily schedules achieve similar clinical and microbiological outcomes.
- Further studies with larger cohorts are warranted, but current findings suggest comparable safety and efficacy for once-daily gentamicin in pediatric patients.
Abstract:
Fifty children aged 3 months--16 y with Gram-negative bacterial infections, were evaluated in this open randomized study; 26 received gentamicin 4.5 mg/kg/day, once daily, and 24 received the same daily dosage, in three divided doses. The groups had similar demographic and clinical characteristics. Serum trough gentamicin concentrations were significantly lower in the od group than in the tds group, while peak concentration were significantly higher in the od group. Clinical cure was obtained in 23 of the 26 (88.8%) children who received gentamicin once daily, and in 22/24 (91%) children treated thrice daily. Microbiological cure was obtained in 10/10 (100%) and 12/13 (92%) of the evaluated cases. Nephrotoxicity was not observed but ototoxicity occurred in two children in each group. These results, although obtained from a small number of patients, showed a similar outcome in children receiving gentamicin 4.5 mg/kg/day whether administered once or thrice daily.