Early Antibiotic Discontinuation in FUO (ANTIBIOSTOP)

Regional University Hospital Center (CHRU)

Status: Completed

Conditions: Febrile Neutropenia; Hematological Malignancy

Treatments: Other: Short-course antibiotic therapy; Other: ECIL-4 guidelines group

Study type: Observational

Funder types: Other

Identifiers

NCT02906254

ANTIBIOSTOP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 123 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

123 participants in 2 patient groups

ECIL-4 guidelines group

Description:

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

Treatment:

Other: ECIL-4 guidelines group

short-course antibiotic therapy

Description:

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).

Treatment:

Other: ECIL-4 guidelines group

Other: Short-course antibiotic therapy