Clinical trial NCT06787326: Effect of the BioFire FilmArray (BCID2) for the Rapid Detection of Bloodstream Infection in Haematologic Patients With Febrile Neutropenia
Official 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Haematological Malignancy
Febrile Neutropenia
Blood Stream Infection
Keywords: Blood Stream Infection
Bacteraemia
Febrile Neutropenia
BioFire FilmArray (BCID2)
Haematologic Malignancy
Neutropenic Cancer Patients
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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 outcomes:
measure: Sensitivity and specificity of BioFire FilmArray BCID2 panel compared to conventional blood cultures.
timeFrame: 14 days
Secondary outcomes:
measure: 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.
timeFrame: 14 days
Other outcomes:
Locations:
city: L'Hospitalet de Llobregat
country: Spain
facility: Bellvitge University Hospital
state: Barcelona
Study officials:
affiliation: Bellvitge University Hospital
name: Carlota Gudiol, Professor, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: