Prediction of Infectious Agents in the Biofire® FilmArray bioMérieux Meningitis/Encephalitis Panel Based on Clinical Syndrome and Cerebrospinal Fluid Parameters: a Diagnostic Stewardship Proposal.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 182
- 试验地点
- 2
- 主要终点
- Rate of BioFire® FilmArray® Meningitis/Encephalitis Panel Positivity
研究概览
简要总结
Background: Infections of the central nervous system (CNS) are associated with high morbidity, mortality, and high resource consumption. The BioFire FilmArray is a molecular diagnostic panel capable of identifying 14 pathogens in approximately one hour, including bacteria, viruses, and fungi. However, it is not yet widely available in the Brazilian public health system.
Objective: The primary objective of this study is to evaluate the pre-test probability of positivity of the Biofire FilmArray bioMérieux Meningitis/Encephalitis panel in patients with clinical syndrome of meningitis and/or encephalitis and pleocytosis (CSF ≥ 5 cells).
As secondary objectives, the study aims to:
Determine the clinical impact of using the panel through variables such as total hospital stay and length of stay in the intensive care unit.
Compare the duration of antibiotic use in non-bacterial cases between groups. Compare the time to reduction of acyclovir use in etiologies without proven benefit.
Compare the time for identification of the causative pathogen and mortality rates between the study groups.
Perform a cost-effectiveness analysis of the test. Compare the request for imaging exams, such as brain MRI and CT scan, between the groups.
Methods: This is a prospective, transversal, and multicenter study conducted at Santa Casa de Porto Alegre and Hospital Dom João Becker. Patients will be compared with a retrospective cohort used as a control group.
详细描述
This will be a prospective study, conducted at Santa Casa de Porto Alegre, a philanthropic tertiary university hospital with 1,400 beds and at Hospital Dom João Becker, which has 173 inpatient beds and 20 ICU beds. Adult patients with clinical symptoms compatible with CNS infection that began less than 30 days prior, for whom cerebrospinal fluid collection has been indicated by the attending physician, will be included. Participation in the study will be subject to the signing of an informed consent form (ICF) by the patient or their legal representative. The patient will then be included in the study. Samples will be processed with qualitative and quantitative cytology, protein, glucose, and lactate analysis, as well as specific tests as requested by the attending physician. Patients will be compared with a retrospective cohort used as a control group (patients with clinical CNS infection who underwent cerebrospinal fluid collection but were not tested with the FilmArray panel) over the past 4 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Patients aged 18 years or older, of any gender.
- •Presence of at least two of the following symptoms: fever, lethargy, altered level of consciousness, seizures, acute focal deficit, signs of meningeal irritation, or headache.
- •Symptoms must have started within the last 30 days.
- •Obligatory presence of pleocytosis (CSF white blood cell count ≥ 5 cells/mm³).
- •Provision of written Informed Consent (TCLE) by the patient or their legal representative.
排除标准
- •Failure to sign the Informed Consent Form.
- •Clinical manifestations lasting more than 30 days.
- •Patients under 18 years of age.
- •Patients who have undergone neurosurgery within 30 days prior to the onset of symptoms (applies to both prospective and control groups).
研究组 & 干预措施
Biofire FilmArray group
Patients with clinical suspicion of CNS infection and pleocytosis (CSF ≥ 5 cells/mm³) who will be prospectively tested using the BioFire FilmArray Meningitis/Encephalitis panel
干预措施: Biofire FilmArray Meningitis/Encephalitis Panel (Diagnostic Test)
Retrospective Control Group
A retrospective cohort of patients from the last four years who presented with similar clinical syndromes and CSF pleocytosis (≥ 5 cells/mm³) but were managed with standard care without molecular panel testing.
结局指标
主要结局
Rate of BioFire® FilmArray® Meningitis/Encephalitis Panel Positivity
时间窗: At the time of BioFire® FilmArray® result availability, assessed up to 24 months
Proportion of positive BioFire® FilmArray® Meningitis/Encephalitis panel results among participants presenting with a clinical syndrome of meningitis and/or encephalitis and cerebrospinal fluid pleocytosis (≥ 5 cells/mm³).
次要结局
- Total hospital length of stay in days(From hospital admission until hospital discharge or death, whichever occurs first, assessed up to 24 months.)
- Intensive care unit length of stay in days(From intensive care unit admission until intensive care unit discharge or death, whichever occurs first, assessed up to 24 months.)
- Duration of antibiotic therapy in participants without confirmed bacterial infection(From antibiotic initiation until discontinuation, hospital discharge, or death, whichever occurs first, assessed up to 24 months.)
- Duration of acyclovir therapy in participants without confirmed indication(From acyclovir initiation until discontinuation, hospital discharge, or death, whichever occurs first, assessed up to 24 months.)
- Time to pathogen identification(From cerebrospinal fluid collection until pathogen identification, when available, assessed up to 24 months.)
- In-hospital mortality(From hospital admission until death or hospital discharge, whichever occurs first, assessed up to 24 months.)
- Need for hemodialysis(From hospital admission until hospital discharge or death, whichever occurs first, assessed up to 24 months.)
- Direct medical costs(From hospital admission until hospital discharge or death, whichever occurs first, assessed up to 24 months.)
- Use of neuroimaging(From hospital admission until hospital discharge or death, whichever occurs first, assessed up to 24 months.)
研究者
Alessandro Pasqualotto
Head of the infectious diseases department and the molecular biology laboratory
Federal University of Health Science of Porto Alegre