Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06787326

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Haematological Malignancy Agranulocytosis Blood Stream Infection Cytopenia Febrile Neutropenia Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Infections Leukocyte Disorders Leukopenia Neoplasms Neoplasms by Site Neutropenia Toxemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bellvitge University Hospital

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Sensitivity and specificity of BioFire FilmArray BCID2 panel compared to conventional blood cultures.

    Time frame: 14 days

    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.

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.

    Time frame: 14 days

    • 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.

Sponsors and collaborators

Lead sponsor

Hospital Universitari de Bellvitge

Other

Registry information

Official study title

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

Acronym: ONFIRE

Important dates

Study start
2023
Primary completion
2023
Study completion
2026
First posted
Jan 22, 2025
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.