Clinical trial NCT02906254: Early Antibiotic Discontinuation in FUO
Official title: Early Discontinuation of Empirical Antibacterial Therapy in Febrile Neutropenia: Prospective Observational Study (ANTIBIOSTOP)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Febrile Neutropenia
Hematological Malignancy
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2016-09-20
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Safety of a short-term antibiotic treatment in afebrile or febrile patients exhibiting FUO, irrespective of their neutrophil count.
timeFrame: Month 1
measure: tolerability of a short-term antibiotic treatment in afebrile or febrile
timeFrame: Month 1
Secondary outcomes:
measure: Epidemiology of febrile neutropenia
timeFrame: Month 1
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
affiliation: Department of Hematology, Brest Teaching Hospital, Hospital Morvan, Avenue Foch, 29200 Brest, France
name: Gaelle Guillerm, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Internal Medicine, Infectious Diseases and Hematology, Cornouaille Hospital Quimper, Avenue Yves Thépot, 29000 Quimper, France
name: Jean-Philippe Talarmin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Hematology, Brest Teaching Hospital, Hospital Morvan, Avenue Foch, 29200 Brest, France
name: Lenaïg Le Clech, MD
role: PRINCIPAL_INVESTIGATOR
References: