Usefulness of a Multiplex Polymerase Chain Reaction (mPCR) Assay for the Diagnosis of Postoperative Pneumonia After Thoracic Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Number of patients in whom the preoperative microorganism (colonization) is the same than that identified in POP.
研究概览
简要总结
Background: In thoracic surgery, postoperative pneumonia (POP) is the leading cause of postoperative morbidity and mortality. The clinical diagnosis of POP is difficult and conventional microbiological diagnostic tests perform poorly. The contribution of molecular diagnostic tests (multiplex PCR, mPCR) should be evaluated to optimize the diagnostic and therapeutic management of POP.
Objectives: The main objective is to describe the microbiological relationship between the existence of pre- (if available) and intra-operative bronchial and pulmonary bacterial colonization and the occurrence of POP. The secondary objectives are to analyze the contribution of the mPCR for the diagnosis of POP and to validate the predictive factors of POP described in the literature Material and methods: A monocentric prospective non-interventional research with minimal risks and constraints. The study population is represented by all the consecutive adult patients hospitalized for lung surgical resection (except surgical resection indicated for infectious disease) during one year. The preoperative respiratory samples within the 3 preceding months (date and type, pathogen and threshold) are recorded, if available. Intra-operative bronchial aspirate is performed for direct examination and culture (pathogen and threshold) and mPCR (PCR1). A mPCR is optionally performed on the surgical specimen (PCR2). In case of postoperative clinical suspicion of POP, invasive or non invasive samples of respiratory tract secretions are obtained for direct examination and culture (pathogen, threshold) and mPCR (PCR3). A clinical pulmonary infection score (CPIS) is calculated by integrating the results of conventional tests (CPIS1) and mPCR (CPIS2).
The pre / intra operative and postoperative microbiological relationship will be described qualitatively and quantitatively and analyzed using correlation tests. Concordances and discrepancies between conventional tests and mPCR will be studied to analyze the contribution of molecular tests in this context.
详细描述
Background: Post operative pneumonia (POP) is a common and severe complication associated with a high morbidity and mortality, regardless of the type of surgery. In thoracic surgery, the global incidence of POP is estimated at 25%. Pre-operative bronchial and pulmonary bacterial colonization appear as a major risk factor for the occurrence of POP, according to the literature.
The diagnosis of POP is challenging, because the usual diagnostic criteria are poorly relevant and clinical diagnostic scores are not validated, which may explain the scarcity of published data in the literature.
Patients' fragility and comorbid conditions mainly due to smoking limit the opportunity to perform invasive microbiological diagnostic tests, and those latter perform poorly. Altogether, the pathogen(s) involved are identified in 14% to 50%.
The evaluation of the diagnostic contribution of molecular diagnostic tests (mPCR) is important in this context. Molecular diagnostic tests offer better performance (sensitivity and sensibility) than conventional test, and the results are not affected by previous exposure to antibiotics. These tests could be useful to analyze the microbiological relationship between pre or per-operative bronchial and pulmonary colonization and postoperative infection, to optimize the diagnostic and the management of POP after thoracic surgery.
Materials and methods: In this study, The investigators aim to describe the microbiological relationship between the existence of pre- (if available) and intra-operative bronchial and pulmonary bacterial colonization and the occurrence of POP. The investigators also intend to analyze the contribution of mPCR for the diagnosis of POP.
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
- •Adult patients hospitalized for lung surgical resection
- •Consenting to research
排除标准
- •surgical resection indicated for infectious disease
结局指标
主要结局
Number of patients in whom the preoperative microorganism (colonization) is the same than that identified in POP.
时间窗: Defined by the patient's hospitalization, from surgery to hospital discharge, until 28 days of follow up
The diagnosis of POP is based on the CPIS using clinical data and microbiology (CPIS1 and CPIS2). The final diagnosis is: Certain: Clinical evidence of pneumonia, quantitative positive respiratory tract samples (RTS) above the thresholds Probable: Strong clinical suspicion (CPIS\>6), RTS below the thresholds, no ongoing or recently introduced antibiotics (atb); or RTS below the thresholds with ongoing or recently introduced atb, regardless the clinical suspicion Possible: Low clinical suspicion (CPIS≤6), RTS below the thresholds, no ongoing or recently introduced atb; or CPIS≤6, negative RTS and ongoing or recently introduced atb Unlikely: Negative RTS with no ongoing or recently introduced atb; or CPIS≤6, negative RTS and ongoing or recently introduced atb. Comparing CPIS1 and CPIS2, we also asses the diagnostic contribution of molecular tests
次要结局
- The rate of diagnostic concordance between conventional and molecular tests in the context of post operative pneumonia in thoracic surgery.(Defined by the patient's hospitalization, from surgery to hospital discharge, including the period management of post operative pneumonia, until 28 days of follow up)
- The measurement of the association of general characteristics, pneumological and functional respiratory characteristics related to the surgical procedure with the occurrence of POPs in the entire study population.(Defined by the patient's hospitalization, from surgery to hospital discharge, including the period management of post operative pneumonia, until 28 days of follow up)
- Mesure of the theoretical impact of molecular diagnostic test results on the antibiotics use.(Defined by the patients' hospitalization, from surgery to hospital discharge, including the period management of post operative pneumonia, until 28 days of follow up)