Early Antibiotic Discontinuation in FUO

University Hospital, Brest123 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

123

Conditions

Febrile Neutropenia Hematological Malignancy

Interventions

ECIL-4 guidelines groupOTHER

Antibiotics were stopped when patients had been afebrile for more than 48 hours

Short-course antibiotic therapyOTHER

Antibiotics were stopped on day 5 in febrile or afebrile patients

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

CHRU de Brest

Brest, France

Outcomes

Primary Outcomes

Safety of a short-term antibiotic treatment in afebrile or febrile patients exhibiting FUO, irrespective of their neutrophil count.

mortality, intensive care admissions, infection

Time frame: Month 1

tolerability of a short-term antibiotic treatment in afebrile or febrile

Duration of antibiotic therapy (days), duration of fever (days)

Time frame: Month 1

Secondary Outcomes

Epidemiology of febrile neutropenia

Clinical and biological data

Time frame: Month 1

Data from ClinicalTrials.gov

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