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Early Antibiotic Discontinuation in FUO (ANTIBIOSTOP)

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ClinicalTrials.gov Identifier: NCT02906254
Recruitment Status : Completed
First Posted : September 20, 2016
Last Update Posted : September 20, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

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
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.


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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 : February 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Fever

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




Primary Outcome Measures :
  1. Safety of a short-term antibiotic treatment in afebrile or febrile patients exhibiting FUO, irrespective of their neutrophil count. [ Time Frame: Month 1 ]
    mortality, intensive care admissions, infection

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


Secondary Outcome Measures :
  1. Epidemiology of febrile neutropenia [ Time Frame: Month 1 ]
    Clinical and biological data



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02906254


Locations
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France
CHRU de Brest
Brest, France, 29609
Sponsors and Collaborators
University Hospital, Brest
Investigators
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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

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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT02906254     History of Changes
Other Study ID Numbers: ANTIBIOSTOP
First Posted: September 20, 2016    Key Record Dates
Last Update Posted: September 20, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Neutropenia
Febrile Neutropenia
Fever
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Body Temperature Changes
Signs and Symptoms