Haematological MalignancyONFIRENCT06787326
Effect of the BioFire FilmArray (BCID2) for the Rapid Detection of Bloodstream Infection in Haematologic Patients With Febrile Neutropenia
An observational study of Haematological Malignancy and Febrile Neutropenia, run by Hospital Universitari de Bellvitge at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Haematological Malignancy, Febrile Neutropenia, Blood Stream Infection
- How many people
- 228 participants
- Where
- 1 siteSpain
- Study dates
- 27 Oct 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Bellvitge University Hospital
L'Hospitalet de Llobregat, Barcelona, 08907
About this study
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
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.
- Keywords
- Blood Stream Infection, Bacteraemia, Febrile Neutropenia, BioFire FilmArray (BCID2), Haematologic Malignancy, Neutropenic Cancer Patients
- Medical subject headings
- Hematologic Neoplasms, Febrile Neutropenia, Toxemia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
- 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.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start27 Oct 2023
- Primary completion27 Nov 2023
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Haematological MalignancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlota Gudiol, Hospital Universitari de Bellvitge
- Investigators
- Carlota Gudiol, Professor, MD, PhD, Principal investigator, Hospital Universitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06787326
- Sponsor's protocol ID
- ICPS029/22
- Other IDs
- PI21/01280
- Acronym
- ONFIRE
- Status last verified
- Dec 2024
- First submitted
- 16 Jan 2025
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Patient´s age and sex, underlying disease and immunosuppressive therapies, clinical presentation, vital signs, duration of neutropenia, date of the initial blood cultures collection, cultures from other sites of infection collected within a time window of 10 days, blood count and chemistry, (including inflammatory biomarkers), and antimicrobial prescription (previous, current and posterior to the febrile neutropenia onset during study observation and 30 days before). Data regarding the microbiological results of the collected samples for each episode of febrile neutropenia will be collected. Date and time of febrile neutropenia episode, of blood cultures drawing and of blood cultures reception at Microbiology Laboratory will be registered. For both strategies microorganism identification, time to species identification, resistance mechanisms and time to resistance mechanism detection will be registered.
Publications
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.
PubMed 40499967
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06787326
- Acronym / sponsor ID
- ONFIRE / ICPS029/22
- Keywords
- Blood Stream Infection, Bacteraemia, Febrile Neutropenia, BioFire FilmArray (BCID2), Haematologic Malignancy, Neutropenic Cancer Patients
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Study start
- 27 Oct 2023 (actual)
- Primary completion
- 27 Nov 2023 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Derived from this study: PubMed 40499967Bergas 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.
- BioFire FilmArray BCID2 panel manufacturer's instructionsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient´s age and sex, underlying disease and immunosuppressive therapies, clinical presentation, vital signs, duration of neutropenia, date of the initial blood cultures collection, cultures from other sites of infection collected within a time window of 10 days, blood count and chemistry, (including inflammatory biomarkers), and antimicrobial prescription (previous, current and posterior to the febrile neutropenia onset during study observation and 30 days before). Data regarding the microbiological results of the collected samples for each episode of febrile neutropenia will be collected. Date and time of febrile neutropenia episode, of blood cultures drawing and of blood cultures reception at Microbiology Laboratory will be registered. For both strategies microorganism identification, time to species identification, resistance mechanisms and time to resistance mechanism detection will be registered.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlota Gudiol, Professor, MD, PhD principal investigator
Hospital Universitari de Bellvitge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Haematological Malignancy and Febrile Neutropenia, run by Hospital Universitari de Bellvitge at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of BioFire FilmArray BCID2 panel compared to conventional blood cultures. (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06787326, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.