University Hospitals Leuven
Leuven, Vlaams-Brabant, 3000, Belgium
Location status: Recruiting
Recruiting
NCT Number: NCT05926063
Stopping Antibiotics After 3 Days for the Treatment of High-risk FEbrile Neutropenia
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
16 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion 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.
Exclusion criteria
- 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.
Treatment and study plan
Comparison short vs extended EBAT treatment group
OtherThis 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).
Primary outcomes
-
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.
Time frame: 42 days
Secondary outcomes
-
Incidence of bacteraemia within 42 days after randomisation
Time frame: 42 days
-
Clinically documented infections
Time frame: 42 days
-
Number of documented bacterial infections
Time frame: 42 days
-
Total days of non-prophylactic antibiotics given to the patient at engraftment
Time frame: 42 days
-
Total numbers of antibiotic switches before neutrophil recovery
Time frame: 42 days
-
Incidence of Clostridium difficile infection
Time frame: 42 days
-
Incidence, severity and duration of diarrhea
Time frame: 42 days
-
Incidence of candidemia
Time frame: 42 days
-
Length of hospital stay in the first 42 days after randomization
Time frame: 42 days
-
Number of patients admitted to the ICU within 42 days after randomisation
Time frame: 42 days
-
Number of readmissions within 42 days
Time frame: 42 days
-
Number of patients with a culture (surveillance or diagnostic culture) positive for resistant bacteria: VRE; ESBL; MRSA; and/or CPE
Time frame: 42 days
-
Duration of hospitalization
Time frame: 42 days
-
Number of patients in the short treatment arm with ongoing fever at time of EBAT stop
Time frame: 42 days
-
Incidence of acute GVHD (grade II or higher) in the transplanted study population
Time frame: 42 days
Study contacts
Contact information is provided by the study sponsor or research team.
Johan Maertens, MD, PhD
CONTACT
Robina Aerts, MD
CONTACT
Sponsors and collaborators
Lead sponsor
Universitaire Ziekenhuizen KU Leuven
Other
Collaborators
- AZ Sint-Jan AV
- Centre Hospitalier Universitaire de Liege
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Universitair Ziekenhuis Brussel
- University Hospital, Antwerp
- University Hospital, Ghent
Registry information
Official study title
Stopping Antibiotics After 3 Days for the Treatment of FEbrile Neutropenia in Haematology Patients (SAFE Study): a Randomized Open-label Non-inferiority Trial
Acronym: SAFE
Important dates
- Study start
- 2024
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Jul 3, 2023
- Registry last updated
- Mar 8, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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