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New treatment option for Neutropenia, Febrile
Official title Stopping Antibiotics After 3 Days for the Treatment of High-risk FEbrile Neutropenia
ClinicalTrials.gov ID: NCT05926063
What this study is testing
- What it's testing
- 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'.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 and older
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
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 (ANC \< 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.
Where it's taking place
- Leuven, Vlaams-Brabant, Belgium
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, 16 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leuven, Vlaams-Brabant, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.