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Multiplex Polymerase Chain Reaction in Postoperative Pneumonia After Thoracic Surgery

NCT03752320 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2019-07-25

No results posted yet for this study

Summary

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.

Conditions

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Muriel Martoukh, MD PhD · Assistance Publique - Hôpitaux de Paris

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-07
Primary Completion
2020-02-29
Completion
2020-02-29

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03752320 on ClinicalTrials.gov