Early Antibiotic Discontinuation in FUO

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Febrile Neutropenia, Hematological Malignancy

Intervention / Treatment
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* Other: ECIL-4 guidelines group
* Other: Short-course antibiotic therapy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ECIL-4 guidelines group<br>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<br>* Antibiotics were stopped when patients had been afebrile for more than 48 hours<br>|
| short-course antibiotic therapy<br>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<br>* Antibiotics were stopped when patients had been afebrile for more than 48 hours<br>Other: Short-course antibiotic therapy<br>* Antibiotics were stopped on day 5 in febrile or afebrile patients<br>|

What is the study measuring?
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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 |