Actively Recruiting
Stopping Antibiotics After 3 Days for the Treatment of High-risk FEbrile Neutropenia
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-03-08
410
Participants Needed
1
Research Sites
122 weeks
Total Duration
On this page
Sponsors
U
Universitaire Ziekenhuizen KU Leuven
Lead Sponsor
U
University Hospital, Ghent
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Stopping Antibiotics After 3 Days for the Treatment of High-risk FEbrile Neutropenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary written informed consent obtained prior to screening
- Age older than 16 years
- Intensive therapy started within 3 days before randomization for acute myeloid leukemia, myelodysplastic syndrome, or preparation for autologous or allogeneic hematopoietic stem cell transplantation
- Expected neutropenia lasting 7 days or more with absolute neutrophil count below 0.5 x 10^9/L
- Expected hospital stay of at least 10 days
You will not qualify if you...
- Clinically or microbiologically documented infection
- Already receiving broad spectrum antibiotic therapy
- Critical illness requiring Intensive Care Unit treatment
- SOFA score 11 or higher
- Neutropenia lasting longer than 21 days before inclusion
- Previous enrollment in this study
- Unable to provide written informed consent
- Any disorder that might risk participant's safety or protocol compliance
- Prior or concurrent treatments that could affect safety or trial integrity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Hospitals Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
Research Team
R
Robina Aerts, MD
CONTACT
J
Johan Maertens, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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