Early Antibiotic Discontinuation in FUO

Completed

• Conditions: Febrile Neutropenia; Hematological Malignancy

• 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.

Study Timeline

• Study Start: 2014-02
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2016-09
• Study First Submitted: 2016-09-02
• Study First Submitted QC: 2016-09-14
• Last Update Submitted: 2016-09-14
• Study First Posted: 2016-09-20
• Last Update Posted: 2016-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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