Abstract
8550 Background: Febrile neutropenia is a major acute side effect of therapy in pediatric cancer, necessitating prompt initiation of empirical broad-spectrum antibiotics. Methods: Since 1994, monotherapy has been used for empiric initial treatment in our center. Cefepime (C), a fourth generation cephalosporin, was found as effective and safe as ceftazidime in a previous randomized trial in our center (Kebudi R et al, Med Pediatr Oncol 36:434–441,2001). Piperacillin-tazobactam (PT) is an extended spectrum penicillin combined with a beta-lactam inhibitor tazobactam. The aim of this single institution, prospective randomized study is to compare the efficacy of PT and C as empiric monotherapy of febrile neutropenic children with cancer. 40 episodes of fever and neutropenia were randomized to recieve treatment with either PT or C. Patients were analyzed for absolute neutrophil count (ANC) at entry, days with fever, neutropenia, hospitalization and side effects of drugs. Success with or without modifications of the initial antibiotic was defined as survival through neutropenia, failure was death due to infection. Results: In our study group, with a median age of 13 (2–14)years, PT was administered in 20 episodes [16 patients],and C in 20 episodes [15 patients]. There was no statistical difference in the median ANC at entry (28 vs 62/mm3),days with fever (2 vs 2), days with neutropenia (7 vs 6.5), days with antibiotics (7.5 vs 9.5) and days in hospitalization (7.5 vs 9.5) in the PT and C group respectively. An infection was documented microbiologically in 4(%20) vs in 5(%25) episodes and clinically in 9 (%45) vs in 10 (%50) episodes in the PT vs C arm. Episodes with severe neutropenia (% with ANC<100/mm3) was 70 vs 75% ; episodes with ≥7 days of neutropenia were 60 vs 50% in the PT vs C arm. The success rate with initial therapy was 65 vs 60% and the modification was 35 and 40% in the PT vs C arm. Modifications included aminoglicosides in 30 vs 25%, glycopeptides in 15 vs 25%, antifungals in 10 vs 10% in the PT vs C arm. There were no deaths. No major adverse effects were observed in either group. Conclusions: Piperacilin-tazobactam seems to be as effective and safe as cefepime for the empirical treatment of febrile episodes in neutropenic children with cancer. No significant financial relationships to disclose.
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