NCT05926063

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 410 (estimated)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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).

Timeline

• Start date: 2024-02-26
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2023-07-03
• Last updated: 2024-03-08

Locations

1 site across 1 country: Belgium