Performance of Non-targeted and/or Non-invasive Respiratory Samples for the Rapid Diagnosis of Pneumocystis Pneumonia Using the BDMAX TM Molecular Biology Platform (Becton Dickinson)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Estimation of the positive predictive value
研究概览
简要总结
Incidence and morbi-mortality of Pneumocystis pneumonia (PCP) are increasing. Early and fast diagnosis and treatment improve PCP prognosis. Biological diagnosis is based on the detection of Pneumocystis jirovecii, mainly by PCR, in broncho-alveolar lavage (BAL) obtained from bronchial fibroscopy. However this invasive exam is not always possible in emergency in suspected patient and others non invasive (sputa) and/or non-targeted (bronchial aspiration) are sent to the laboratory (25% of cases, data from the Grenoble University Hospital). Diagnosis performances of these non invasive/non-targeted samples are not clearly established.
In this study, the investigators aimed to establish the diagnosis value of non-invasive and/or non-targeted respiratory samples (oral fluids, sputa and bronchial aspiration) for the PCP diagnosis, compared to the gold-standard (Pneumocystis PCR on BAL, beta-D-glucans testing on serum and radio-clinical records).
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
- •Immunocompromised patient with (i) clinical and/or radiological suspicion of PCP, and (ii) bronchial fibroscopy with contributive BAL
- •No immediate life-threatening conditions (estimated life expectancy >12h)
- •No PCP treatment or PCP treatment < 48h
- •Patient hospitalized in the Grenoble Alpes University Hospital with medical insurance
- •Informed and written consent of the patient or its related
排除标准
- •Pregnancy, breastfeeding
- •Exclusion period of another clinical trial
- •Deprivation of liberty
结局指标
主要结局
Estimation of the positive predictive value
时间窗: 30 months
Estimation of the predictive values of Pneumocystis PCR on non-invasive and/or non-targeted respiratory samples compared to the gold-standard
Sensitivity
时间窗: 30 months
Sensitivity of Pneumocystis PCR on non-invasive and/or non-targeted respiratory samples compared to the gold-standard
Area Under the Curve (AUC)
时间窗: 30 months
AUCs of Pneumocystis PCR on non-invasive and/or non-targeted respiratory samples compared to the gold-standard
Specificity
时间窗: 30 months
Specificity of Pneumocystis PCR on non-invasive and/or non-targeted respiratory samples compared to the gold-standard
Estimation of the negative predictive value
时间窗: 30 months
Estimation of the negative predictive values of Pneumocystis PCR on non-invasive and/or non-targeted respiratory samples compared to the gold-standard
次要结局
- Optimal cut-off values for interpretation of Pneumocystis fungal load on non-invasive and/or non-targeted respiratory samples(30 months)
- Estimation of the number of patients who would have received an earlier appropriate anti-PCP treatment based on a PCP diagnosis on non-invasive and/or non-targeted respiratory samples(30 months)
- Time-saving (in hours) of PCP diagnosis on non-invasive and/or non-targeted respiratory samples compared to the PCP diagnosis on BAL, taking into account the time needed for bronchial fibroscopy(30 months)
- Duration of anti-PCP treatment (days)(30 months)
- Estimation of the number of days of presumptive anti-PCP treatment that would have been avoided based on a PCP diagnosis on non-invasive and/or non-targeted respiratory samples(30 months)