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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-500389-84 | EudraCT Number |
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| Name | Class |
|---|---|
| University Hospital, Ghent | OTHER |
| Universitair Ziekenhuis Brussel | OTHER |
| University Hospital, Antwerp | OTHER |
| AZ Sint-Jan AV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short treatment group | Experimental | Empirical broad-spectrum antibiotics (EBAT) as per local protocol:
Short treatment group: EBAT will be discontinued:
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| Extended treatment group | Active Comparator | Empirical broad-spectrum antibiotics (EBAT) as per local protocol:
Extended treatment arm: EBAT will be continued:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparison short vs extended EBAT treatment group | Other | 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). |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of bacteraemia within 42 days after randomisation | 42 days | |
| Clinically documented infections | 42 days | |
| Number of documented bacterial infections |
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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:
Expected longstanding (≥ 7 days) neutropenia (ANC < 0.5x10^9/L);
Expected length of hospital stay of at least 10 days.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robina Aerts, MD | Contact | +32 16 34 48 77 | robina.aerts@kuleuven.be | |
| Johan Maertens, MD, PhD | Contact | +32 16 34 66 70 | johan.maertens@uzleuven.be |
| Name | Affiliation | Role |
|---|---|---|
| Johan Maertens, MD, PhD | Universitaire Ziekenhuizen KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Leuven | Recruiting | Leuven | Vlaams-Brabant | 3000 | Belgium |
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| ID | Term |
|---|---|
| D064147 | Febrile Neutropenia |
| D009503 | Neutropenia |
| D007938 | Leukemia |
| D007239 | Infections |
| ID | Term |
|---|---|
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
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| OTHER |
| Centre Hospitalier Universitaire de Liege | OTHER |
| Cliniques universitaires Saint-Luc- Université Catholique de Louvain | OTHER |
Comparison of two treatment strategies
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| 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 |
| Incidence of candidemia | 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 |
| Number of patients in the short treatment arm with ongoing fever at time of EBAT stop | 42 days |
| Incidence of acute GVHD (grade II or higher) in the transplanted study population | 42 days |
| D006425 |
| Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |