Blood Stream Infection, Febrile Neutropenia, Haematological Malignancy
Conditions
Keywords
Blood Stream Infection, Bacteraemia, Febrile Neutropenia, BioFire FilmArray (BCID2), Haematologic Malignancy, Neutropenic Cancer Patients
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.
Interventions
None listed
Sponsors
Hospital Universitari de Bellvitge
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Countries
Spain
Outcome results
None listed