drugset / Trial / NCT02463747

Short vs Prolonged Antibiotic Treatment for Hospitalized Hemato-oncology Patients With Febrile Neutropenia

NCT02463747 ↗

Phase 4 Unknown 110 enrolled Tel-Aviv Sourasky Medical Center
RandomizedParallel-groupOpen-labelTreatment

Summary

Neutropenic fever is a life threatening condition that is not rare in patients suffering from hematologic disorders, and of paramount importance to early and effective treatment. In this trial we concentrate on hospitalized patients with hematologic malignancies who develop neutropenic fever. In recent years, several studies were conducted to examine possible changes in the conventional empirical treatment, assuming that administration of the antibiotics in a prolonged infusion would allow for a greater fT \> MIC that will lead to a better efficacy. These studies were carried out in different populations and there is only limited information about the importance of continuous infusion therapy in patients with hematologic diseases with neutropenic fever. Research goals: The main goal is to compare between two groups of hematologic patients with neutropenic fever, The first group will receive antibiotic therapy in extended infusion, and the second (control) group will receive the treatment in a fixed time.

Timeline

Start
2015-06
Primary completion
2017-06
Completion
2017-07

Outcome

Met primary endpoint

paper Overall response occurred in 35 (74.4%) patients treated with extended infusion and 32 (55.1%) patients treated with bolus infusion (P = .044). PMID 29608680 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Ceftazidim Unknown 2 g Intravenous
Subject Meropenem Small molecule 1 g Intravenous
Subject Piperacillin/tazobactam Unknown 4.5 g Intravenous
Background Vancomycin Other / unclassified — —

Indications