Amira Bisher, Hoda M.A. Hassab, Ibrahim A. Ahmed, Ahmed A.H. Ali, Ahmad Salahuddin, M. E. Abdelrahim, E.E. Eldenshary
Background: Febrile-neutropenia places acute-leukemic children at high morbidity and mortality risks. Recently, monotherapy-regimen has been instituted instead of combination-regimens as an early empirical-treatment. Since there have been few or no trials conducted to compare monotherapy to combination-therapy in terms of efficacy and tolerability, the present prospective study aimed to compare safety and efficacy of these regimens in febrile-neutropenic children with acute-leukemia and to come across the association between various patient baseline qualities and the success outcome. Method: Seventy-eight children were assigned to receive meropenem, cefepime/amikacin or ceftazidime/amikacin intravenously in three divided doses. All responses were evaluated as failures-or-success in fulfillment of pre-defined criteria. Time-to-defervescence, duration-of-therapy, duration-of-neutropenia, modification, success-rate, adverse-effects and infection-documentation were compared between the three groups. Survival-analysis and Log-rank test were used to quantitatively relate baseline co-variables to the success-rate. Results: A total of 78 (36 females) acute-leukemic children were assessed in Intention-To-Treat analysis for comparing safety and response of three different antibacterial empirical therapies. The Success-rate in meropenem-monotherapy, ceftazidime/amikacin and cefepime/amikacin was reported to be 9/15 (60%) vs. 19/31 (59.4%) vs. 24/31 (77.4%), respectively with no significant difference shown between groups (X2 = 3.801; p = 0.434). Moreover, no significant difference was found with any other primary effectiveness endpoints. On one hand, the three regimens were equally well tolerated. Only platelets count among all variables has shown significant effect on the success outcome occurrence (HR = 1.003; 95% CI: 1.001-1.006, X2 = 6.417, p = 0.011). Conclusions: Meropenem-monotherapy is equally safe and effective to chosen combination-therapy as an initial treatment in acute-leukemic children admitted with febrile-neutropenia
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