Early Antibiotic Discontinuation in FUO

Febrile Neutropenia Clinical Trial

— ANTIBIOSTOP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02906254
• Other study ID #: ANTIBIOSTOP
• Status: Completed
• Phase: N/A
• First received: September 2, 2016
• Last updated: September 14, 2016
• Start date: February 2014
• Est. completion date: September 2015

Study information

• Verified date: September 2016
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertés
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Febrile Neutropenia
• Fever
• Hematological Malignancy
• Neutropenia

Intervention

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

Locations

Country	Name	City	State
France	CHRU de Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of a short-term antibiotic treatment in afebrile or febrile patients exhibiting FUO, irrespective of their neutrophil count.	mortality, intensive care admissions, infection	Month 1	Yes
Primary	tolerability of a short-term antibiotic treatment in afebrile or febrile	Duration of antibiotic therapy (days), duration of fever (days)	Month 1	Yes
Secondary	Epidemiology of febrile neutropenia	Clinical and biological data	Month 1	No