Short-term antibiotics for 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

This study tests if a short course of antibiotics is just as safe and effective as the usual longer treatment for adults with febrile neutropenia.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 410 (estimated)
• Ages: 16 Years and up
• Sex: All
• Sponsor: Universitaire Ziekenhuizen KU Leuven (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Leuven, Vlaams-Brabant)
• Trial ID: NCT05926063 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the safety and effectiveness of a short course of antibiotics against the standard long-term antibiotic treatment in adult patients experiencing febrile neutropenia. Participants will be randomly assigned to receive either short-term or long-term antibiotic therapy after developing neutropenic fever, with additional samples collected for analysis. The goal is to determine if the shorter treatment duration is equally safe for patients who do not have a bacterial infection.

Who should consider this trial

Good fit: Ideal candidates are adults over 16 years old undergoing intensive therapy for specific hematological conditions and expected to have prolonged neutropenia.

Not a fit: Patients with clinically or microbiologically documented infections or those already receiving broad-spectrum antibiotics may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could reduce unnecessary antibiotic use and associated side effects in patients with febrile neutropenia.

How similar studies have performed: Other studies have explored short-term antibiotic treatments, but this specific approach is novel in the context of febrile neutropenia management.

Eligibility criteria

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.

Where this trial is running

Leuven, Vlaams-Brabant

• University Hospitals Leuven — Leuven, Vlaams-Brabant, Belgium (Recruiting)

Study contacts

• Principal investigator: Johan Maertens, MD, PhD — Universitaire Ziekenhuizen KU Leuven
• Study coordinator: Robina Aerts, MD

Conditions Neutropenia, Febrile; Neutropenia; Leukemia; Stem Cell Transplant Complications; Infections