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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- Sensitivity and specificity of BioFire FilmArray BCID2 panel compared to conventional blood cultures.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Sensitivity and specificity of BioFire FilmArray BCID2 panel compared to conventional blood cultures.
时间窗: 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.
次要结局
- 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)
研究者
Carlota Gudiol
Professor, MD, PhD
Hospital Universitari de Bellvitge