Stopping Antibiotics After 3 Days for the Treatment of High-risk FEbrile Neutropenia

Last updated: March 6, 2024
Sponsor: Universitaire Ziekenhuizen KU Leuven
Overall Status: Active - Recruiting

Phase

4

Condition

Fever

Neutropenia

Treatment

Comparison short vs extended EBAT treatment group

Clinical Study ID

NCT05926063
S66527
2022-500389-84
  • Ages > 16
  • All Genders

Study 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

Inclusion Criteria:

  • Voluntary written informed consent of the participant or their legally authorizedrepresentative 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 thefollowing 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 fora 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

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'ssafety or compliance with the protocol;
  9. Any prior or concomitant treatment(s) that might jeopardise the participant's safetyor that would compromise the integrity of the Trial.

Study Design

Total Participants: 410
Treatment Group(s): 1
Primary Treatment: Comparison short vs extended EBAT treatment group
Phase: 4
Study Start date:
February 26, 2024
Estimated Completion Date:
July 31, 2026

Connect with a study center

  • University Hospitals Leuven

    Leuven, Vlaams-Brabant 3000
    Belgium

    Active - Recruiting

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