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Effect of the BioFire FilmArray (BCID2) for the Rapid Detection of Bloodstream Infection in Haematologic Patients With Febrile Neutropenia | Clinical Trials | Clareo Health

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Effect of the BioFire FilmArray (BCID2) for the Rapid Detection of Bloodstream Infection in Haematologic Patients With Febrile Neutropenia

Effect of the BioFire FilmArray (BCID2) for the Rapid Detection of Bloodstream Infection in Haematologic Patients With Febrile Neutropenia (ONFIRE Study): Study Protocol of a Prospective, Multicentre Observational Study

NCT06787326•Hospital Universitari de Bellvitge

View on ClinicalTrials.gov

Summary

The goal of this observational study is to assess if the molecular diagnostic tool BioFire FilmArray BCID2 is more useful for the microbiological diagnosis of bloodstream infections in hematological patients with febrile neutropenia, compared to the conventional microbiologic studies. The study compares the sensibility and specificity of these two techniques.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≥18 years
•Patients hospitalised for the treatment of haematological malignancy or undergoing an autologous or allogeneic hematopoietic stem cell transplant or receiving CAR-T cell therapy
•Patients presenting with febrile neutropenia (defined as axillary temperature ≥ 38.0°C and \<500 neutrophils/mm3 or \<1000 with an expected rapid decrease in 24-48 hours),
•Patient to whom blood cultures are ordered as standard care for the microbiological diagnosis of the febrile neutropenia episode.

Exclusion Criteria

•Axillary temperature \<37.5ºC.
•High clinical suspicion of a non-infectious cause of fever at the moment when blood cultures are drawn (high suspicion of drug related fever, infusion reaction).
•Previously enrolled patients in whom the time between inclusion and the current episode is less than four weeks.
•Patients with febrile neutropenia in whom no blood cultures are drawn.

Locations (1)

Bellvitge University Hospital

L'Hospitalet de Llobregat, Barcelona, Spain

Key Dates

Start Date

October 27, 2023

Primary Completion Date

November 27, 2023

Completion Date

December 31, 2026

Last Updated

January 22, 2025

Enrollment

228

ESTIMATED participants

Conditions

Haematological MalignancyFebrile NeutropeniaBlood Stream Infection

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Effect of the BioFire FilmArray (BCID2) for the Rapid Detection of Bloodstream Infection in Haematologic Patients With Febrile Neutropenia

Inclusion Criteria

Exclusion Criteria

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