BridgeMD
SAFE study: Stopping Antibiotics after 3 days for the treatment of FEbrile Neutropenia in Haematology patients, a randomized open-label non-inferiority trial
EU CTIS ID: 2022-500389-84-00
What this study is testing
To assess if a strategy of short antibiotic treatment (72h) with a broad-spectrum antibiotic is as safe as extended treatment of high-risk febrile neutropenia in hematology patients.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 (absolute neutrophil count < 0.5x10^9/L)
- Expected length of hospital stay of at least 10 days
You likely can't join if
- Clinically or microbiologically documented infection
- Patient already receives broad spectrum antibiotic therapy
- Any critical illness for which Intensive Care Unit treatment is required
- SOFA score ≥ 11
- Longstanding neutropenia (>21 days) prior inclusion
- Previous enrolment in this study
See the full eligibility 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 (absolute neutrophil count < 0.5x10^9/L)
- Expected length of hospital stay of at least 10 days
- Clinically or microbiologically documented infection
- Patient already receives broad spectrum antibiotic therapy
- Any critical illness for which Intensive Care Unit treatment is required
- SOFA score ≥ 11
- Longstanding neutropenia (>21 days) prior inclusion
- Previous enrolment in this study
- Not able to provide written informed consent
- Any disorder, which in the Investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol
- Any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.