Early Antibiotic Discontinuation in FUO
- Conditions
- Febrile NeutropeniaHematological Malignancy
- Interventions
- Other: ECIL-4 guidelines groupOther: Short-course antibiotic therapy
- Registration Number
- NCT02906254
- Lead Sponsor
- University Hospital, Brest
- Brief Summary
Febrile neutropenia requires prompt initiation of broad-spectrum antibiotics, which can be responsible for side-effects and selection of resistance. This study demonstrates the safety of an early discontinuation of empirical treatments, in carefully selected patients presenting with fever of unknown origin.
- Detailed Description
Infections are responsible for significant morbidity and mortality in haematological patients, in particular during chemotherapy-induced neutropenia. Guidelines recommend immediate initiation of antibiotic therapy, whose optimal duration is unclear. The primary objective of this study is to evaluate early discontinuation of antibiotic treatment for Fever of Unknown Origin (FUO) in afebrile or febrile neutropenic patients. The secondary objective is to describe the epidemiology of febrile neutropenia (FN) in investigator centre.
Every episode of FN was prospectively identified. In the first phase of the study, empirical antibiotic therapy of FUO patients was stopped after 48 hours of apyrexia, in accordance with ECIL-4 (European Conference on Infections in Leukaemia) recommendations. In the second phase of the study, antibiotics were stopped on day 5 for all FUO patients, regardless of their temperature or their leukocyte count.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 123
- age ≥ 18 years;
- presence of a malignant haematological disease combined with chemotherapy-induced neutropenia (polymorphonuclear neutrophil (PMN) count ≤ 500/mm3)
- fever defined by tympanic temperature of ≥38°C for ≥1 hour or a single temperature of ≥38.3°C
- Patients without curative care
- chronic neutropenia (PMN≤ 500/mm3 for 3 months or more)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description ECIL-4 guidelines group ECIL-4 guidelines group For the FUO group, antibiotics were stopped based on two procedures, irrespective of the neutrophil count or expected duration of neutropenia: - From 1st February 2014 to 30th November 2014, antibiotics were stopped when patients had been afebrile for more than 48 hours, as recommended by the ECIL-4 guidelines short-course antibiotic therapy Short-course antibiotic therapy For the FUO group, antibiotics were stopped based on two procedures, irrespective of the neutrophil count or expected duration of neutropenia: - From 1st December 2014 to 30th September 2015, antibiotics were stopped on day 5 in febrile or afebrile patients (short-course antibiotic therapy). short-course antibiotic therapy ECIL-4 guidelines group For the FUO group, antibiotics were stopped based on two procedures, irrespective of the neutrophil count or expected duration of neutropenia: - From 1st December 2014 to 30th September 2015, antibiotics were stopped on day 5 in febrile or afebrile patients (short-course antibiotic therapy).
- Primary Outcome Measures
Name Time Method tolerability of a short-term antibiotic treatment in afebrile or febrile Month 1 Duration of antibiotic therapy (days), duration of fever (days)
Safety of a short-term antibiotic treatment in afebrile or febrile patients exhibiting FUO, irrespective of their neutrophil count. Month 1 mortality, intensive care admissions, infection
- Secondary Outcome Measures
Name Time Method Epidemiology of febrile neutropenia Month 1 Clinical and biological data
Trial Locations
- Locations (1)
CHRU de Brest
🇫🇷Brest, France