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Stopping Antibiotics After 3 Days for the Treatment of High-risk FEbrile Neutropenia

NCT05926063 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 410

Last updated 2024-03-08

No results posted yet for this study

Summary

The goal of this clinical trial is to compare a short course of antibiotics in patients in whom no bacterial infection is found with the current "golden standard": long-term antibiotic treatment in adult hematology patients who develop neutropenic fever.

The main question it aims to answer is: whether the short-term treatment is equally safe for patients, hence the name 'SAFE study'.

Participants will be randomly assigned (randomized) to one of two treatment options once they develop neutropenic fever: short-term or long-term antibiotic treatment. An additional blood sample, urine sample and stool sample will be collected.

Researchers will compare the short-term and the long-term antibiotic treatment groups to see if the short treatment is equally safe as the long-term treatment group.

Conditions

  • Neutropenia, Febrile

Interventions

OTHER

Comparison short vs extended EBAT treatment group

This study compares two management strategies of patients undergoing treatment with chemotherapy or a stem cell transplantation. One strategy is to treat these patients at the time of febrile neutropenia with a fixed 72 hours course of EBAT. The other, more commonly followed strategy is a longer minimum EBAT duration of 5 days as well as other variables like neutrophil recovery and defervescence. In both arms, definitive treatment is given when an infectious cause of the fever is found according to local guidelines (e.g. pneumonia or mucosits with bacteremia).

Sponsors & Collaborators

  • University Hospital, Ghent

    collaborator OTHER

  • Universitair Ziekenhuis Brussel

    collaborator OTHER

  • University Hospital, Antwerp

    collaborator OTHER

  • AZ Sint-Jan AV

    collaborator OTHER

  • Centre Hospitalier Universitaire de Liege

    collaborator OTHER

  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    collaborator OTHER

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • Johan Maertens, MD, PhD · Universitaire Ziekenhuizen KU Leuven

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-26
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • Belgium

Study Locations

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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 NCT05926063 on ClinicalTrials.gov