Meropenem versus ceftazidime in the treatment of cancer patients with febrile neutropenia: A randomized, double-blind trial

Purpose: To compare meropenem, ct carbapenem antibiotic, with ceftazidime f or the empirical treatment of patients with febrile neutropenia. Patients and Methods: A prospective, double-blind, randomized clinical tria l was conducted at medical centers in North America and the Netherlands. A total of 411 cancer patients (196 treated with meropenem and 215 treated wi th ceftazidime), who had 471 episodes of fever, participated in the trial. For each neutropenic episode, patients were allocated at random to receive intravenous administration of meropenem (1 g every 8 hours) or ceftazidime (2 g every 8 hours). Treatment could be modified at any time. Key end point s were clinical and bacteriologic outcomes, eradication of infecting organi sm, and adverse events. Results: The rate of successful clinical response at the end of therapy was significantly higher for patients treated with meropenem than for those on ceftazidime for all episodes (54% v 44%, respectively) and for episodes of fever of unknown origin (62% v46%, respectively), but differences between groups were not statistically significant for clinically defined or microbi ologically defined infections. Meropenem was significantly more effective t han ceftazidime in severely neutropenic (less than or equal to 100 cells/mu l) patients (55% v 43%, respectively), bone marrow transplant patients (73% v 27%, respectively), and patients given antibiotic prophylaxis before stu dy entry (71% v 52%, respectively). Common adverse effects of meropenem and ceftazidime therapy were rash, diarrhea, and nausea and vomiting. Conclusion: Monotherapy with meropenem represents a suitable choice for ini tial empirical antibiotic therapy for febrile episodes in neutropenic cance r patients. (C) 2000 by American Society of Clinical Oncology.