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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Febrile Neutropenia; Haematological Malignancy; Blood Stream Infection

• Study Type: Observational
• Enrollment (Estimated): 228

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Bellvitge University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

This study will include adult patients (age ≥18 years) hospitalised for the treatment of leukaemia, lymphoproliferative syndrome, myelodysplastic syndrome, multiple myeloma, medullary aplasia, or patients undergoing an autologous or allogeneic hematopoietic stem cell transplant or receiving CAR-T cell therapy, who develop febrile neutropenia (defined as axillary temperature ≥ 38.0°C and <500 neutrophils/mm3 or <1000 with an expected rapid decrease in 24-48 hours), and who have diagnostic blood cultures ordered as standard care for the microbiological diagnosis of the febrile neutropenia episode.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and specificity of BioFire FilmArray BCID2 panel compared to conventional blood cultures.	For the analysis of the primary endpoint: The sensitivity (proportion of positive results) of the BioFire FilmArray BCID2 panel will be compared with the sensitivity of the companion blood cultures. The results of the BioFire FilmArray samples that meet the definitions of "Proven bloodstream infection", "Probable bloodstream infection" and "Possible bloodstream infection" will be considered as positive results. The results will be assessed at Day 14 from the sample collection. The positive predictive value of both techniques will be calculated and compared.; The specificity (proportion of negative results) of the FilmArray BCID2 panel will be compared with the specificity of the companion blood cultures. The results will be assessed at Day 14 from the sample collection. The negative predictive value of both techniques will be calculated and compared.	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and specificity of BioFire FilmArray BCID2 Panel compared to conventional blood cultures in the subgroup of patients under antibiotic treatment or whom received antibiotic 48h before the febrile neutropenia onset.	The sensitivity of the Biofire FilmArray BCID2 panel will be compared with the sensitivity of the companion blood cultures in the subgroup of patients with recent (<48 h) or concomitant use of systemic antibiotics. The results of the Biofire FilmArray samples that meet the definitions of "Proven BSI", "Probable BSI" and "Possible BSI" will be considered as positive results. The results will be assessed at Day 14 from the blood sample collection. The positive predictive value of both techniques will be calculated and compared.; The specificity of the Biofire FilmArray BCID2 panel will be compared with the specificity of the companion blood cultures in the subgroup of patients with recent (<48 h) or concomitant use of systemic antibiotics. The results will be assessed at Day 14 from the sample collection. The negative predictive value of both techniques will be calculated and compared.	14 days

Collaborators and Investigators

• Sponsor: Hospital Universitari de Bellvitge
• Investigators: Principal Investigator: Carlota Gudiol, Professor, MD, PhD, Bellvitge University Hospital

Publications and helpful links

Helpful Links

• BioFire FilmArray BCID2 panel manufacturer's instructions

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2023
• Primary Completion (Actual): November 27, 2023
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 16, 2025
• First Submitted That Met QC Criteria: January 21, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 21, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Blood Stream Infection; Febrile Neutropenia; Bacteraemia; BioFire FilmArray (BCID2); Haematologic Malignancy; Neutropenic Cancer Patients
• Additional Relevant MeSH Terms: Cytopenia; Wounds and Injuries; Pathologic Processes; Neoplasms by Site; Disease Attributes; Systemic Inflammatory Response Syndrome; Inflammation; Leukocyte Disorders; Hematologic Diseases; Leukopenia; Body Temperature Changes; Agranulocytosis; Heat Stress Disorders; Hyperthermia; Neoplasms; Hematologic Neoplasms; Sepsis; Infections; Communicable Diseases; Neutropenia; Febrile Neutropenia; Fever
• Other Study ID Numbers: ICPS029/22; PI21/01280 (Other Grant/Funding Number: Instituto de Salud Carlos III)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient´s age and sex, underlying disease and immunosuppressive therapies, clinical presentation, vital signs, duration of neutropenia, date of the initial blood cultures collection, cultures from other sites of infection collected within a time window of 10 days, blood count and chemistry, (including inflammatory biomarkers), and antimicrobial prescription (previous, current and posterior to the febrile neutropenia onset during study observation and 30 days before). Data regarding the microbiological results of the collected samples for each episode of febrile neutropenia will be collected. Date and time of febrile neutropenia episode, of blood cultures drawing and of blood cultures reception at Microbiology Laboratory will be registered. For both strategies microorganism identification, time to species identification, resistance mechanisms and time to resistance mechanism detection will be registered.
• IPD Sharing Time Frame: The study protocol is being written, and is planned to be published during the first six months of 2025
• IPD Sharing Access Criteria: The study protocol will be published in an Open access journal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No