Pacheco-Rosas DO, Peregrino-Bejarano L, López-Aguilar JE, Juan-Shum L, Miranda-Novales MG

Language: Spanish
References: 25
Page: 65-73
PDF size: 269.82 Kb.

ABSTRACT

Background: Pediatric patients with febrile neutropenia usually receive a combination of broad spectrum antimicrobials. Treatment without aminoglycoside seems to have advantages.
Objective: To compare the efficacy of piperacillin/tazobactam plus amikacin versus piperacillin/tazobactam.
Methods: Randomized, open label, controlled clinical trial. Sample size for an efficacy of 55%, and delta of 25%; 80 episodes were required for each group. Selection criteria were patients with febrile neutropenia, candidates to receive parenteral antimicrobial treatment; they were randomized to one of two groups, piperacillin/tazobactam plus amikacin (Group A), or piperacillin/tazobactam (Group B). The outcomes were failure, adverse events and death. Mantel-Haenszel chi square test and exact Fisher test were used. Reduction of relative and absolute risk (RRR and ARR), 95% confidence intervals (CI 95%) and number needed to treat (NNT) were calculated.
Results: 88 Episodes were analyzed in group A and 76 in group B. There was no statistical difference in general characteristics of patients or type of infections. There was not significant statistical difference in: failure 31.8% group A, 30.2% group B (RR 1.05, CI 95% 0.66-1.66, p = 0.86), or adverse events (one in each group). The RRR was 1.5%, and ARR 2%, with a NNT of 67.
Conclusion: piperacillin/tazobactam without amikacin was as effective as combination therapy in pediatric patients with febrile neutropenia.

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