Neutropenia, Febrile
Conditions
Keywords
Neutropenia, Leukemia, Stem Cell Transplant Complications, Infections
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.
Interventions
OTHERComparison short vs extended EBAT treatment group
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).
Sponsors
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
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Comparison of two treatment strategies
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
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's safety or compliance with the protocol; 9. Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Incidence of Clostridium difficile infection | 42 days |
| Incidence, severity and duration of diarrhea | 42 days |
| Number of patients in the short treatment arm with ongoing fever at time of EBAT stop | 42 days |
| Length of hospital stay in the first 42 days after randomization | 42 days |
| Number of patients admitted to the ICU within 42 days after randomisation | 42 days |
| Number of readmissions within 42 days | 42 days |
| Number of patients with a culture (surveillance or diagnostic culture) positive for resistant bacteria: VRE; ESBL; MRSA; and/or CPE | 42 days |
| Duration of hospitalization | 42 days |
| Incidence of acute GVHD (grade II or higher) in the transplanted study population | 42 days |
| Incidence of candidemia | 42 days |
Countries
Belgium
Contacts
Primary ContactRobina Aerts, MD
Backup ContactJohan Maertens, MD, PhD
Outcome results
None listed