Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neutropenia, Febrile | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Comparison short vs extended EBAT treatment group | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Short treatment group
- description
- Empirical broad-spectrum antibiotics (EBAT) as per local protocol: * Meropenem 3 x 1(/2) g IV; OR * Piperacilline-Tazobactam 4 x 4 g IV; OR * Cefepime 3 x 2 g IV; OR * Ceftazidim 3 x 2 g IV Short treatment group: EBAT will be discontinued: * After 3x24 hours; * Irrespective of presence of fever; AND * If no clinical of microbiological infection is documented.
- interventionNames
- Other: Comparison short vs extended EBAT treatment group
- type
- ACTIVE_COMPARATOR
- label
- Extended treatment group
- description
- Empirical broad-spectrum antibiotics (EBAT) as per local protocol: * Meropenem 3 x 1(/2) g IV; OR * Piperacilline-Tazobactam 4 x 4 g IV; OR * Cefepime 3 x 2 g IV; OR * Ceftazidim 3 x 2 g IV Extended treatment arm: EBAT will be continued: * At least 5x24 hours; * Until afebrile (TMT\<38.0°C) for at least 5 consecutive days; OR * Until resolution of neutropenia (ANC \>0,5 x109/L); OR * Until they have been treated 10 days, whatever comes first.
- interventionNames
- Other: Comparison short vs extended EBAT treatment group
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: * Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures; * Age older than 16 years; * Intensive therapy is started within three days before randomization for one of the following haematological conditions: * Remission induction chemotherapy for newly diagnosed acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS); OR * Re-induction chemotherapy for relapsed after haematological remission lasting for a minimum duration of 6 months; OR * Conditioning regimen to prepare for an allogeneic HCT; OR * Conditioning regimen to prepare for an autologous HCT. * Expected longstanding (≥ 7 days) neutropenia (ANC \< 0.5x10\^9/L); * Expected length of hospital stay of at least 10 days. Exclusion Criteria: 1. Clinically or microbiologically documented infection; 2. Patient already receives broad spectrum antibiotic therapy; 3. Any critical illness for which Intensive Care Unit treatment is required; 4. SOFA score ≥ 11; 5. Longstanding neutropenia (\>21 days) prior inclusion; 6. Previous enrolment in this study; 7. Not able to provide written informed consent; 8. Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol; 9. Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial.
References
Publications (0)
Data not yet available