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

NCT02463747 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2015-06-04

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Piperacillin/tazobactam

Initial treatment will be with Piperacillin + Tazobactam

DRUG

Ceftazidim

Patient with sensitivity to penicillin will receive Ceftazidim

DRUG

Meropenem

In cases of hypotension that do not respond to fluids resuscitation , and in consultation with the infectious diseases unit - we will start empirical treatment with Meropenem

DRUG

Vancomycin

Supplementation of Vancomycin will be at the discretion of the treating physician

Sponsors & Collaborators

  • Tel-Aviv Sourasky Medical Center

    lead OTHER_GOV

Principal Investigators

  • Dr. Ron Ram, MD · Head of BMt Unit / hematology division

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2017-06-30
Completion
2017-07-31

Countries

  • Israel

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02463747 on ClinicalTrials.gov