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Short Versus Extended Antibiotic Treatment With a Carbapenem for High-risk Febrile Neutropenia in Hematology Patients With FUO

NCT02149329 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 276

Last updated 2019-09-25

No results posted yet for this study

Summary

A multicenter open-label non-inferiority randomized clinical trial comparing the safety (non-inferiority) of short antibiotic treatment (72 hours) with an anti-pseudomonal carbapenem with regard to treatment failure in comparison with extended treatment (at least 9 days) of high-risk febrile neutropenia in hematology patients receiving standard antimicrobial prophylaxis.

Conditions

Interventions

DRUG

Discontinuation of imipenem-cilastatin or meropenem

Discontinuation of imipenem-cilastatin or meropenem after 3x24 hours irrespective of presence of fever.

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • FondsNutsOhra

    collaborator UNKNOWN

  • Amsterdam UMC, location VUmc

    lead OTHER

Principal Investigators

  • Jeroen JWM Janssen, MD, PhD · Amsterdam UMC, location VUmc

  • Michiel A van Agtmael, MD, PhD · Amsterdam UMC, location VUmc

  • Mark MH Kramer, Prof., MD · Amsterdam UMC, location VUmc

  • Sonja Zweegman, Prof.,MD · Amsterdam UMC, location VUmc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2019-08-05
Completion
2019-08-05

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

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 NCT02149329 on ClinicalTrials.gov