RecruitingPhase 4NCT05926063

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

Stopping Antibiotics After 3 Days for the Treatment of FEbrile Neutropenia in Haematology Patients (SAFE Study): a Randomized Open-label Non-inferiority Trial

Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrollment

410 participants

Start Date

Feb 26, 2024

Study Type

INTERVENTIONAL

Conditions

Neutropenia, Febrile

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.

Eligibility

Min Age: 16 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether stopping antibiotics after just 3 days (rather than continuing longer) is safe for people with blood cancer who develop a fever when their immune system is very weak due to chemotherapy. **You may be eligible if...** - You are older than 16 years - You are receiving intensive chemotherapy for a blood cancer such as acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or you are preparing for a bone marrow transplant - Your white blood cell count is expected to be very low for at least 7 days - You are expected to stay in hospital for at least 10 days **You may NOT be eligible if...** - You already have a confirmed infection - You are already on broad-spectrum antibiotics - You need intensive care unit treatment - You had very low white blood cell counts for more than 21 days before joining the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERComparison 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).

Locations(1)

University Hospitals Leuven

Leuven, Vlaams-Brabant, Belgium

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NCT05926063