NCT05926063|CompletedPhase 4
Stopping Antibiotics After 3 Days for the Treatment of High-risk FEbrile Neutropenia
SAFE
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SAFE
Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
interventional
450
1 country
1
Study Start
February 26, 2024
Actual (reported)Primary Completion
March 8, 2026
Actual (reported)Study Completion
May 14, 2026
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 14, 2026
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 21, 2023
Actual (reported)July 3, 2023
Actual (reported)February 26, 2024
Actual (reported)March 8, 2026
Actual (reported)May 14, 2026
Actual (reported)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
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
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.
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 48h; OR * Until resolution of neutropenia (ANC \>0,5 x109/L); OR * Until they have been treated 10 days, whatever comes first.
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).
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
IMIPENEM
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INFUSION
View registry recordFormulated product
MEROPENEM
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
POWDER FOR SOLUTION FOR INJECTION/INFUSION
View registry recordFormulated product
CEFTAZIDIME
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry recordFormulated product
PIPERACILLIN
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
POWDER FOR SOLUTION FOR INJECTION OR INFUSION
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
IMIPENEM
Named ingredient: Imipenem
View registry recordMEROPENEM
Named ingredient: Meropenem
View registry recordCEFTAZIDIME
Named ingredient: Ceftazidime
View registry recordPIPERACILLIN
Named ingredient: Piperacillin
View registry recordUniversity Hospitals Leuven
Leuven, Vlaams-Brabant, 3000, Belgium
Johan Maertens, MD, PhD
Universitaire Ziekenhuizen KU Leuven
Yuri Charles Vanbiervliet, MD
Universitaire Ziekenhuizen KU Leuven
450 participants (actual enrollment reported by the registry).
First Submitted
June 21, 2023
First Posted
July 3, 2023
Study Start
February 26, 2024
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
March 8, 2026
Actual (reported)Study Completion
May 14, 2026
Actual (reported)Last Updated
October 23, 2026
Record last verified: 2026-05
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