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Clinical Trials/NCT02906254
NCT02906254CompletedNot Applicable

Early Discontinuation of Empirical Antibacterial Therapy in Febrile Neutropenia: Prospective Observational Study (ANTIBIOSTOP)

University Hospital, Brest1 site in 1 country123 target enrollmentStarted: February 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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