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

NCT06787326 | Active Not Recruiting

• 2 other identifiers: ICPS029/22PI21/01280
• Study Type: observational
• Target: 228
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Haematological Malignancy; Febrile Neutropenia; Blood Stream Infection

Keywords

Blood Stream Infection; Bacteraemia; Febrile Neutropenia; BioFire FilmArray (BCID2); Haematologic Malignancy; Neutropenic Cancer Patients

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

  14 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).
• Patients with febrile neutropenia in whom no blood cultures are drawn.

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead

Study Sites (1)

Bellvitge University Hospital

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Related Publications (1)

• Bergas A, Lopez de Egea G, Albasanz-Puig A, Machado M, Vinado B, Estevez-Prieto A, Maluquer C, Carro I, Perez-Gonzalez A, Regalado-Artamendi I, Gomez-Centurion IA, Laporte-Amargos J, Sastre-Escola E, Badia-Tejero AM, Garcia P, Larrosa N, Munoz P, Berbel D, Ardanuy C, Carratala J, Gudiol C. Effectiveness of the BioFire FilmArray for the rapid detection of bloodstream infection in haematological patients with febrile neutropenia (the ONFIRE study): study protocol of a prospective, multicentre observational study at three reference university hospitals in Spain. BMJ Open. 2025 Jun 10;15(6):e101040. doi: 10.1136/bmjopen-2025-101040.

  PMID: 40499967 DERIVED

Related Links

• BioFire FilmArray BCID2 panel manufacturer's instructions

MeSH Terms

Conditions

Hematologic Neoplasms; Febrile Neutropenia; Toxemia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Neutropenia; Agranulocytosis; Leukopenia; Cytopenia; Leukocyte Disorders; Infections

Study Officials

• Carlota Gudiol, Professor, MD, PhD

  Bellvitge University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 22, 2025
• Study Start: October 27, 2023
• Primary Completion: November 27, 2023
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 22, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The study protocol is being written, and is planned to be published during the first six months of 2025
• Access Criteria: The study protocol will be published in an Open access journal.

Locations

ES (1)