Early Antibiotic Discontinuation in FUO (ANTIBIOSTOP)

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

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.

Study Overview

• Status: Completed
• Conditions: Febrile Neutropenia; Hematological Malignancy
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 123

Contacts and Locations

Study Locations

• France
  • Brest, France, 29609
    • CHRU de Brest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Any patient admitted to the Department of Clinical Haematology of Brest Teaching Hospital (France) was eligible for this study.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
tolerability of a short-term antibiotic treatment in afebrile or febrile	Duration of antibiotic therapy (days), duration of fever (days)	Month 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epidemiology of febrile neutropenia	Clinical and biological data	Month 1

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: September 2, 2016
• First Submitted That Met QC Criteria: September 14, 2016
• First Posted (Estimate): September 20, 2016

Study Record Updates

• Last Update Posted (Estimate): September 20, 2016
• Last Update Submitted That Met QC Criteria: September 14, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Wounds and Injuries; Hematologic Diseases; Agranulocytosis; Leukopenia; Leukocyte Disorders; Body Temperature Changes; Heat Stress Disorders; Hematologic Neoplasms; Neutropenia; Hyperthermia; Fever; Febrile Neutropenia; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: ANTIBIOSTOP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided