Early Discontinuation of Empirical Antibacterial Therapy in Febrile Neutropenia: Prospective Observational Study (ANTIBIOSTOP)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University Hospital, Brest
- Enrollment
- 123
- Locations
- 1
- Primary Endpoint
- tolerability of a short-term antibiotic treatment in afebrile or febrile
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Patients without curative care
- •chronic neutropenia (PMN≤ 500/mm3 for 3 months or more)
Outcomes
Primary Outcomes
tolerability of a short-term antibiotic treatment in afebrile or febrile
Time Frame: 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.
Time Frame: Month 1
mortality, intensive care admissions, infection
Secondary Outcomes
- Epidemiology of febrile neutropenia(Month 1)