Once-Daily High-Dose Netilmicin

Abstract

The primary objective of this study was to compare the efficacy and tolerability of a once-daily dose of netilmicin for 3 to 5 days (OD group) vs three times daily for 7 to 14 days (TID group). 93 patients (47 in the OD group and 46 in the TID group), with moderate to severe Gram-negative infections, were enrolled. Of the 41 patients who were evaluable for efficacy analysis in the OD group, 35 (85%) were cured, 5 (12%) improved and there was 1 (2%) failure. Of the 37 patients in the TID group, 34 (92%) were cured, 2 (5%) improved and there was 1 (3%) failure. There was no statistically significant difference in the response rates between the OD and TID groups (p = 0.715). The influence of the type of infection, the actual dose administered and the netilmicin peak levels on the response rate and the time to response were analysed. The only factor that significantly influenced the time to response and the response rate was the type of infection. Nine patients (3 in the OD group and 6 in the TID group) reported 12 adverse events, but no statistical differences between groups were found. In conclusion, our results suggest that once-daily administration of netilmicin is at least equally effective as three times daily administration.