Clinical trial · Observational
Effect of the BioFire FilmArray (BCID2) for the Rapid Detection of Bloodstream Infection in Haematologic Patients With Febrile Neutropenia
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
NCT06787326CI-TRIAL-00084975ONFIREactive not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Blood Stream Infection | — | UNRESOLVED | — |
| Febrile Neutropenia | — | UNRESOLVED | — |
| Haematological Malignancy | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Sensitivity and specificity of BioFire FilmArray BCID2 panel compared to conventional blood cultures.
- timeFrame
- 14 days
- description
- 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)
- 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
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDBergas 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