prospective randomized clinical trial of ceftazidime versus ceftazidime plus gentamicin versus meropenem versus piperacillin/ tazobactam plus gentamicin in the treatment of febrile neutropenia [FN] in Oman

ABSTRACT

A prospective randomised clinical trial was designed to evaluate the efficacy and safety of 4 frontline intravenous [IV] antibiotic regimens in treatment of FN in adults receiving chemotherapy. During a 3 year enrolment period 120 episodes of FN in 96 patients were randomly allocated to receive one of die 4 IV antibiotic arms [ceftazidime [F] Vs [F] plus gentamicin [FG] Vs meropenum [M] Vs piperacilin/tazobactam plus gentamicin [TG]]. Main end points were clinical outcome, number of days to become afebrile and cost of treatment. 117 episodes in 96 patients [52 males and 44 females - median age of 44.9 years, 42% lymphomas and 58% solid tumours] were evaluable for response. F= 30, FG=29, M=28 and TG= 30 episodes. Bacteraemia was reported in 19% [12% gram-negative and 7% gram-positive], clinically confirmed infection in 36%, and fever of unknown reason in 45% of studied cases. No statistical significance was found between the 4 arms in terms of response rate [RR] [80%, 83%, 85% and 87% respectively]. The mean time to fever defervescence was significantly shorter in the TG arm [F=3.3, FG=3.1, M=2.8 and TG=2.1 days P=0.014]. Overall episode treatment cost was significantly lower for TG arm [p=0.005]. The 4 arms showed equal RR. However, time to clinical response, and total cost was in favour of TG combination