NCT05926063

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
410

participants targeted

Target at P75+ for phase_4

Timeline
2mo left

Started Feb 2024

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Feb 2024Jul 2026

First Submitted

Initial submission to the registry

June 21, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 3, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

February 26, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

March 8, 2024

Status Verified

June 1, 2023

Enrollment Period

2.3 years

First QC Date

June 21, 2023

Last Update Submit

March 6, 2024

Conditions

Neutropenia, Febrile

Keywords

NeutropeniaLeukemiaStem Cell Transplant ComplicationsInfections

Outcome Measures

Primary Outcomes (1)

  • Absence of a serious medical complication (SMC) following 42 days after randomisation. SMC is defined as: Death; and/or ICU admission; and/or Septic shock requiring vasopressive therapy.

    42 days

Secondary Outcomes (15)

  • Incidence of bacteraemia within 42 days after randomisation

    42 days

  • Clinically documented infections

    42 days

  • Number of documented bacterial infections

    42 days

  • Total days of non-prophylactic antibiotics given to the patient at engraftment

    42 days

  • Total numbers of antibiotic switches before neutrophil recovery

    42 days

  • +10 more secondary outcomes

Study Arms (2)

Short treatment group

EXPERIMENTAL

Empirical broad-spectrum antibiotics (EBAT) as per local protocol: * Meropenem 3 x 1(/2) g IV; OR * Piperacilline-Tazobactam 4 x 4 g IV; OR * Cefepime 3 x 2 g IV; OR * Ceftazidim 3 x 2 g IV Short treatment group: EBAT will be discontinued: * After 3x24 hours; * Irrespective of presence of fever; AND * If no clinical of microbiological infection is documented.

Other: Comparison short vs extended EBAT treatment group

Extended treatment group

ACTIVE COMPARATOR

Empirical broad-spectrum antibiotics (EBAT) as per local protocol: * Meropenem 3 x 1(/2) g IV; OR * Piperacilline-Tazobactam 4 x 4 g IV; OR * Cefepime 3 x 2 g IV; OR * Ceftazidim 3 x 2 g IV Extended treatment arm: EBAT will be continued: * At least 5x24 hours; * Until afebrile (TMT\<38.0°C) for at least 5 consecutive days; OR * Until resolution of neutropenia (ANC \>0,5 x109/L); OR * Until they have been treated 10 days, whatever comes first.

Other: Comparison short vs extended EBAT treatment group

Interventions

Comparison short vs extended EBAT treatment groupOTHER

This study compares two management strategies of patients undergoing treatment with chemotherapy or a stem cell transplantation. One strategy is to treat these patients at the time of febrile neutropenia with a fixed 72 hours course of EBAT. The other, more commonly followed strategy is a longer minimum EBAT duration of 5 days as well as other variables like neutrophil recovery and defervescence. In both arms, definitive treatment is given when an infectious cause of the fever is found according to local guidelines (e.g. pneumonia or mucosits with bacteremia).

Extended treatment groupShort treatment group

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify 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 (ANC \< 0.5x10\^9/L);
  • Expected length of hospital stay of at least 10 days.

You may not qualify 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;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Febrile NeutropeniaNeutropeniaLeukemiaInfections

Condition Hierarchy (Ancestors)

AgranulocytosisLeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte DisordersNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Johan Maertens, MD, PhD

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Robina Aerts, MD

CONTACT

+32 16 34 48 77robina.aerts@kuleuven.be

Johan Maertens, MD, PhD

CONTACT

+32 16 34 66 70johan.maertens@uzleuven.be

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Comparison of two treatment strategies
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2023

First Posted

July 3, 2023

Study Start

February 26, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

March 8, 2024

Record last verified: 2023-06

Locations

BE(1)