MEROPENEM VERSUS CEFTAZIDIME PLUS AMIKACIN IN THE TREATMENT OF FEBRILE EPISODES IN NEUTROPENIC PATIENTS - A RANDOMIZED STUDY

Background and Objective. Meropenem is the first of a new class of car bapenems which may be administered without cilastatin. This study was performed to assess the clinical efficacy and tolerability of meropene m monotherapy (1 g/8 h) compared with the standard combination of ceft azidime (2 g/8 h) plus amikacin (15 mg/kg/day) for the empirical treat ment of infective febrile episodes in neutropenic cancer patients. Met hods. This was a three-center, randomized, non-blind parallel group tr ial. The primary objective was to compare the clinical efficacy of mer openem monotherapy with that of ceftazidime plus amikacin in the empir ical treatment of febrile infective episodes in neutropenic patients. This was evaluated by the number of patients surviving on unmodified t herapy at 72 h (primary end point) and by the clinical response at the end of therapy (secondary end point). Results. A total of 93 febrile episodes (46 meropenem, 47 ceftazidime/amikacin) were evaluable. Bone marrow transplant patients accounted for 49.5% of all cases. There was a high incidence of Gram-positive infections but no pseudomonal infec tions. Microbiologically documented infections, clinically documented infections and unexplained fever accounted for 45%, 10% and 45% of epi sodes, respectively. There was a similar proportion of patients in the meropenem and ceftazidime/amikacin groups on unmodified empiric thera py at 72 h (80.4% vs 76.6%, p=0.65,) and cured at the end of therapy ( 37% vs 36.2%, p=0.9). No significant difference in tolerability was ob served between the groups. Meropenem was well tolerated; of note, ther e were no cases of nausea/vomiting or seizure related to its use. Inte rpretation and conclusions. Meropenem monotherapy was well tolerated a nd produced response rates similar to those obtained with ceftazidime/ amikacin. The low overall success rates with both treatments concur wi th those of other recent studies and are probably due to a combination of several factors, including the adoption of strict assessment crite ria. (C) 1997, Ferrata Storti Foundation.