ANTIBIOSTOP: Early Antibiotic Discontinuation in FUO

Sponsor

University Hospital, Brest (Other)

Overall Status

Completed

CT.gov ID

NCT02906254

Collaborator

(none)

123

Enrollment

Location

Duration (Months)

6.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Febrile Neutropenia Hematological Malignancy	Other: ECIL-4 guidelines group Other: Short-course antibiotic therapy

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 Design

Study Type:

Observational

Actual Enrollment :

123 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Feb 1, 2014

Actual Primary Completion Date :

Sep 1, 2015

Actual Study Completion Date :

Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
ECIL-4 guidelines group 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	Other: ECIL-4 guidelines group Antibiotics were stopped when patients had been afebrile for more than 48 hours
short-course antibiotic therapy 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).	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

Arm

Intervention/Treatment

ECIL-4 guidelines group

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

Other: ECIL-4 guidelines group

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

short-course antibiotic therapy

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).

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

Outcome Measures

Primary Outcome Measures

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
tolerability of a short-term antibiotic treatment in afebrile or febrile [Month 1]
Duration of antibiotic therapy (days), duration of fever (days)

Secondary Outcome Measures

Epidemiology of febrile neutropenia [Month 1]
Clinical and biological data

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHRU de Brest	Brest		France	29609

Sponsors and Collaborators

University Hospital, Brest

Investigators

Principal Investigator: Gaelle Guillerm, MD, Department of Hematology, Brest Teaching Hospital, Hospital Morvan, Avenue Foch, 29200 Brest, France
Principal Investigator: Jean-Philippe Talarmin, MD, Department of Internal Medicine, Infectious Diseases and Hematology, Cornouaille Hospital Quimper, Avenue Yves Thépot, 29000 Quimper, France
Principal Investigator: Lenaïg Le Clech, MD, Department of Hematology, Brest Teaching Hospital, Hospital Morvan, Avenue Foch, 29200 Brest, France