Multiplex Polymerase Chain Reaction in Postoperative Pneumonia After Thoracic Surgery

NCT03752320 | Unknown

• 2 other identifiers: APHP1800102018-A01908-47
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Pneumonia; Bacterial Pneumonia

Keywords

Postoperative pneumonia; Thoracic surgery; Multiplex PCR; Bacterial and pulmonary colonization; Diagnosis; Mortality

Outcome Measures

Primary Outcomes (1)

• Number of patients in whom the preoperative microorganism (colonization) is the same than that identified in POP.

  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

  Defined by the patient's hospitalization, from surgery to hospital discharge, until 28 days of follow up

Secondary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

POP+ and POP-

POP+: patients with postoperative pneumonia POP-: patients without postoperative pneumonia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All the consecutive adult patients hospitalized for lung surgical resection (except surgical resection indicated for infectious disease) for one year at Tenon hospital, a University teaching in Paris, Assistance publique - Hôpitaux de Paris, France. About 200-250 patients undergo a thoracic surgery per year and are supported in the thoracic surgery department of Tenon hospital. If we consider a 25% incidence rate of post operative pneumonia, we expect 50-60 patients to be included during the study period.

You may qualify if:

• Adult patients hospitalized for lung surgical resection
• Consenting to research

You may not qualify if:

• surgical resection indicated for infectious disease

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service de Réanimation et USC médico-chirurgicale Hôpital Tenon, AP-HP

Paris, Île-de-France Region, 75020, France

RECRUITING

MeSH Terms

Conditions

Pneumonia; Pneumonia, Bacterial; Disease

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Muriel Martoukh, MD PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muriel Fartoukh, MD PhD

CONTACT

0033 (0) 1 56 01 65 72; muriel.fartoukh@aphp.fr

Matthieu Turpin, MD

CONTACT

0033 (0) 7 72 77 72 20; matthieu.turpin@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2018
• First Posted: November 26, 2018
• Study Start: February 7, 2019
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: July 25, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)