Efficacy and safety of cefepime in late-onset ventilator-associated pneumonia in infants: a pilot randomized and controlled study.

Multidrug-resistant organisms cause late-onset ventilator-associated pneumonia (VAP). In a pilot, randomized and controlled study, the efficacy and safety of cefepime, in late-onset VAP in infants, have now been evaluated in Malaysia. Thirty children aged <1 year with late-onset VAP (i.e. VAP occurring 5 or more days after intubation) were randomized to receive cefepime or, as a control, ceftazidime. The clinical responses and the microbiological clearance of tracheal aspirates were evaluated in each arm. Adverse events, if any, were monitored clinically and by blood tests. Ten of the 15 children given cefepime and five of the 15 given ceftazidime showed a satisfactory clinical response (P<0.1). Cefepime appeared significantly better at clearing polymicrobial infections from tracheal aspirates. There were no fatalities in the cefepime arm but three in ceftazidime (P<0.1). The mean (S.E.) durations of antibiotic use were 9.4 (1.5) days for cefepime and 7.6 (1.0) days for ceftazidime (P>0.05). No serious adverse effects were observed in either arm. In conclusion, in late-onset VAP in infants, cefepime monotherapy appears to be at least as effective and safe as ceftazidime monotherapy, with better microbiological clearance.

RCT Entities:   Population Interventions Outcomes