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Once-daily gentamicin versus once-daily netilmicin in patients with serious infections--a randomized clinical trial
J M Prins1, H R Büller, E J Kuijper
1Department of Internal Medicine, Academic Medical Center, Amsterdam, The Netherlands.
Abstract:
Consecutive patients with serious infections were randomized between gentamicin 4 mg/kg once daily i.v. or netilmicin 5.5 mg/kg once daily i.v. (with dosage reduction in case of renal dysfunction). Exclusion criteria were neutropenia or severe renal failure. Median first serum trough and peak concentrations were 0.4/9.5 mg/L and 0.4/12.2 mg/L, for gentamicin and netilmicin respectively. A good clinical response was observed in 50/54 (92.6%) evaluable patients treated with gentamicin and in 48/52 (92.3%) netilmicin-treated patients. Nephrotoxicity (a rise of serum creatinine > or = 45 mumol/L) developed in 5/72 (6.9%) gentamicin patients treated > or = 48 hours and in 10/69 (14.5%) netilmicin patients (difference 7.5%, 95% CI -3.9% to +16.2%). High-tone audiometry was performed when possible; no significant differences were found between the regimens with regard to hearing loss or prodromal signs of ototoxicity. We conclude that with once-daily dosing no benefit of netilmicin over gentamicin regarding nephro- or ototoxicity could be demonstrated.
Insights
This study found that once-daily gentamicin and netilmicin showed similar clinical effectiveness and safety for serious infections. No significant differences in nephrotoxicity or ototoxicity were observed between the two aminoglycoside antibiotics.
Area of Science:
- Pharmacology
- Infectious Diseases
- Nephrology
Background:
- Aminoglycoside antibiotics like gentamicin and netilmicin are crucial for treating serious bacterial infections.
- Optimizing dosing strategies, such as once-daily administration, is essential to maximize efficacy and minimize toxicity.
- Comparing the safety and efficacy profiles of different aminoglycosides is important for clinical decision-making.
Purpose of the Study:
- To compare the clinical efficacy and safety of once-daily intravenous gentamicin versus netilmicin in patients with serious infections.
- To evaluate the incidence of nephrotoxicity and ototoxicity associated with each antibiotic regimen.
- To determine if netilmicin offers any advantage over gentamicin in terms of reduced toxicity when administered once daily.
Main Methods:
- A randomized trial comparing intravenous gentamicin (4 mg/kg once daily) with netilmicin (5.5 mg/kg once daily) in patients with serious infections.
- Exclusion criteria included neutropenia and severe renal failure; dosage adjustments were made for renal dysfunction.
- Clinical response, serum drug concentrations, and incidences of nephrotoxicity (rise in serum creatinine) and ototoxicity (hearing assessments) were monitored.
Main Results:
- Both gentamicin and netilmicin demonstrated high clinical response rates (92.6% and 92.3%, respectively).
- Nephrotoxicity occurred in 6.9% of gentamicin recipients and 14.5% of netilmicin recipients (difference 7.5%, 95% CI -3.9% to +16.2%).
- No significant differences were found between the groups regarding hearing loss or signs of ototoxicity.
Conclusions:
- Once-daily intravenous administration of gentamicin and netilmicin yields comparable clinical efficacy in treating serious infections.
- There was no demonstrable benefit of netilmicin over gentamicin in terms of reduced nephrotoxicity or ototoxicity with this dosing strategy.
- These findings suggest that gentamicin remains a viable and effective option for once-daily therapy in serious infections, with similar safety margins to netilmicin.