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Journal of Antimicrobial Chemotherapy (1994) 33, 823-835
© 1994 The British Society for Antimicrobial Chemotherapy

other

Once-daily gentamicin versus once-daily netilmicin in patients with serious infections—a randomized clinical trial

Jan M. Prinsa, Harry R. Büllera, Ed J. Kuijperb, Rinze A. Tangec and Peter Speelmana

aDepartment of Internal Medicine, Unit for Infectious Diseases and Tropical Medicine Room F4-222, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands bMedical Microbiology, Academic Medical Center Room F4-222, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands cOto-Rhino-Laryngology, Academic Medical Center Room F4-222, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands

Received 27 September 1993; accepted 20 December 1993

Consecutive patients with serious infections were randomized between gentamicin 4 mg/kg once daily iv or netilmicin 5•5 mg/kg once daily iv (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 ≥45 µmol/L) developed in 5/72 (6•9%) gentamicin patients treated ≥ 48 hours and in 10/69 (14/5%) netilmicin patients (difference 7•5%, 95% CI –39% 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.


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