H. Bassaris et al., ONCE-DAILY HIGH-DOSE NETILMICIN - A NEW SHORT-TERM TREATMENT REGIMEN FOR PATIENTS WITH MODERATE TO SEVERE GRAM-NEGATIVE INFECTIONS, Clinical drug investigation, 15(3), 1998, pp. 205-216
The primary objective of this study was to compare the efficacy and to
lerability of a once-daily dose of netilmicin for 3 to 5 days (OD grou
p) 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 evalu
able 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 TI
D group, 34 (92%) were cured, 2 (5%) improved and there was (3%) failu
re. 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 pea
k levels on the response rate and the rime 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 st
atistical differences between groups were found. In conclusion, our re
sults suggest that once-daily administration of netilmicin is at least
equally effective as three times daily administration.