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

Study acronym: SAFE
StatusCompleted
PhasePhase 4
Started

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Record History

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  1. Primary endpoints: details revised at 1 of 1 entry Show 8 more changesShow less
    • Trial status changed: Unknown → Completed
    • Primary completion date changed from estimate of Jul 2026 to Mar 8, 2026
    • Enrollment target: estimated 410 to confirmed 450
    • Study completion date changed from estimate of Jul 2026 to May 14, 2026
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 1 of 15 entries
    • Site details revised
    • Collaborators: 6 to 8
  2. Changed Registry marked status Unknown; last known: Recruiting
  3. Trial status: Not Yet Recruiting to Unknown
    • Study sites: 0 to 1
    • Start date changed from estimate of Jan 2024 to Feb 26, 2024
    v3
  4. Start date: Jul 2023 to Jan 2024v2
  5. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05926063
Lead Sponsor Universitaire Ziekenhuizen KU Leuven
Collaborators: University Hospital, Ghent, Universitair Ziekenhuis Brussel, University Hospital, Antwerp, AZ Sint-Jan AV, Centre Hospitalier Universitaire de Liege, Cliniques universitaires Saint-Luc- Université Catholique de Louvain, Jules Bordet Institute, Grand Hôpital de Charleroi
Conditions
(from sponsor)		 Neutropenia, Febrile
Related terms Febrile Neutropenia, Infections, Leukemia, Neutropenia
Enrollment 450 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov