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Stopping Antibiotics After 3 Days for the Treatment of FEbrile Neutropenia in Haematology Patients (SAFE Study): a Randomized Open-label Non-inferiority Trial
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.
Details
| Lead sponsor | Universitaire Ziekenhuizen KU Leuven |
|---|---|
| Phase | Phase 4 |
| Status | RECRUITING |
| Enrolment | 410 |
| Start date | 2024-02-26 |
| Completion | 2026-07 |
Conditions
- Neutropenia, Febrile
Interventions
- Comparison short vs extended EBAT treatment group
Primary outcomes
- Absence of a serious medical complication (SMC) following 42 days after randomisation. SMC is defined as: Death; and/or ICU admission; and/or Septic shock requiring vasopressive therapy. — 42 days
Countries
Belgium