NCT02906254

Early Antibiotic Discontinuation in FUO

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 123 (actual)
• Sponsor: University Hospital, Brest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Febrile Neutropenia
• Hematological Malignancy

Interventions

Type	Name	Description
OTHER	ECIL-4 guidelines group	Antibiotics were stopped when patients had been afebrile for more than 48 hours
OTHER	Short-course antibiotic therapy	Antibiotics were stopped on day 5 in febrile or afebrile patients

Timeline

• Start date: 2014-02-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2016-09-20
• Last updated: 2016-09-20

Locations

1 site across 1 country: France