Once-daily gentamicin versus once-daily netilmicin in patients with serious infections--a randomized clinical trial.
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.
Prins
J M
JM
Department of Internal Medicine, Academic Medical Center, Amsterdam, The Netherlands.
Büller
H R
HR
Kuijper
E J
EJ
Tange
R A
RA
Speelman
P
P
D000368:Aged; D001424:Bacterial Infections / Q000188:drug therapy* / Q000382:microbiology; D003404:Creatinine / Q000097:blood; D005260:Female; D005839:Gentamicins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006311:Hearing Disorders / Q000139:chemically induced; D006801:Humans; D007275:Injections, Intravenous; D007674:Kidney Diseases / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D009428:Netilmicin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D012307:Risk Factors
D005839:Gentamicins; D009428:Netilmicin; D003404:Creatinine