Abstract | OBJECTIVES: This is a prospective, randomized, and open-label clinical trial that examines the efficiency and safety of PIP/TAZO monotherapy in comparison to cefepime (CEF), for the empirical treatment of pediatric cancer patients with neutropenia and fever. METHODS: One hundred thirty-one consecutive febrile episodes in 70 neutropenic pediatric cancer patients received randomized treatment either with piperacillin/tazobactam (PIP/TAZO) 80 mg/kg piperacillin/10 mg/kg tazobactam every 6 hr or CEF 50 mg/kg every 8 hr. Clinical response was determined at completion of therapy. Duration of fever, neutropenia, hospitalization, the need for modification of the therapy, and mortality rates were compared between the two groups. RESULTS: One hundred twenty-seven episodes in 69 patients (35 females, 34 males) with a median age of 4.2 years were assessed for efficiency (65 PIP/TAZO, 62 CEF). The frequency of success without modification of treatment was nearly identical for both PIP/TAZO (60.0%) and CEF (61.3%) (P > 0.05). The overall response rate, with or without modification of assigned treatment, was 96.9% for PIP/TAZO and 98.4% for CEP (P > 0.05). Infection-related mortality at the end of the febrile episode was 2.4%. Duration of fever and hospitalization were not different between the treatment groups. No major side effects were observed in neither of the groups. CONCLUSIONS: PIP/TAZO treatment was as effective and safe as CEF monotherapy as an initial empirical regimen in pediatric cancer patients with fever and neutropenia.
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Authors | Vedat Uygun, Gulsun Tezcan Karasu, Dilara Ogunc, Akif Yesilipek, Volkan Hazar |
Journal | Pediatric blood & cancer
(Pediatr Blood Cancer)
Vol. 53
Issue 4
Pg. 610-4
(Oct 2009)
ISSN: 1545-5017 [Electronic] United States |
PMID | 19484759
(Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anti-Bacterial Agents
- Cephalosporins
- Piperacillin, Tazobactam Drug Combination
- Cefepime
- Penicillanic Acid
- Piperacillin
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Topics |
- Adolescent
- Anti-Bacterial Agents
(therapeutic use)
- Cefepime
- Cephalosporins
(therapeutic use)
- Child
- Child, Preschool
- Female
- Fever
(drug therapy)
- Humans
- Infant
- Male
- Neutropenia
(drug therapy)
- Penicillanic Acid
(analogs & derivatives, therapeutic use)
- Piperacillin
(therapeutic use)
- Piperacillin, Tazobactam Drug Combination
- Prospective Studies
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