NCT05926063 Stopping Antibiotics After 3 Days for the Treatment of High-risk FEbrile Neutropenia
| NCT ID | NCT05926063 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | Neutropenia, Febrile |
| Study Type | INTERVENTIONAL |
| Enrollment | 410 participants |
| Start Date | 2024-02-26 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 410 participants in total. It began in 2024-02-26 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Johan Maertens, MD, PhD
PRINCIPAL INVESTIGATOR
Universitaire Ziekenhuizen KU Leuven
Frequently Asked Questions
Who can join the NCT05926063 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Neutropenia, Febrile. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05926063 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05926063 currently recruiting?
Yes, NCT05926063 is actively recruiting participants. Contact the research team at robina.aerts@kuleuven.be for enrollment information.
Where is the NCT05926063 trial being conducted?
This trial is being conducted at Leuven, Belgium.
Who is sponsoring the NCT05926063 clinical trial?
NCT05926063 is sponsored by Universitaire Ziekenhuizen KU Leuven. The principal investigator is Johan Maertens, MD, PhD at Universitaire Ziekenhuizen KU Leuven. The trial plans to enroll 410 participants.