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Clinical Trials in Spain / NCT06787326
Active, not recruiting Observational

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

NCT06787326 · tracked via the Priya Life Science Spain tracker
Sponsor
Hospital Universitari de Bellvitge
Phase
Observational
Started
2023-10-27
Last updated
2025-01-22

Condition(s) studied

Haematological MalignancyFebrile NeutropeniaBlood Stream Infection

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

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

Trial sites (1)

FacilityCityRegionStatus
Bellvitge University Hospital L'Hospitalet de Llobregat Barcelona

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Other trials for the same condition

Evaluation of Diagnostic Accuracy and Clinical Performance of the UllCORE Bloodstream Infection (BSI) Test Recruiting
Plasma Host-Microbe Proteomics to Predict Complications in High-risk Febrile Neutropenia Recruiting
Study to Evaluate CCS1477 (Inobrodib) in Haematological Malignancies Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06787326 on ClinicalTrials.gov ↗ ← All trials in Spain