Diagnostic and Prognostic Value of Lung Microbiota in Early Lung Infection After Lung Transplantation

Sponsor
Qingyuan Zhan (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05627505
Collaborator
(none)
80
13.3

Study Details

Study Description

Brief Summary

The present study is a prospective case-control study. Patients were enrolled post lung transplantation and alveolar lavage fluid was obtained within 48 hours of the patient's surgery, divided into aliquots and subjected to macrogenomic sequencing, routine microbiological testing and cytokine testing. Patients were divided into pulmonary infection and non-pulmonary infection groups based on whether they had a co-infection at the time of sampling. Pulmonary infection was used as the primary study endpoint. To describe and compare the characteristics of the lung microbiota in the two groups and to determine whether variation in the lung microbiota could predict the development of lung infection and prognosis in patients in the early post-transplant period.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: metagenomic next-generation sequencing

Detailed Description

Lung infection is a common and serious problem in the perioperative period of lung transplantation, and early diagnosis of lung infection is important, while traditional culture methods are time-consuming and have low positivity rates. Pathogenic detection by macro-genomic sequencing (mNGS) may be useful for early and rapid diagnosis of post-operative infections, and the simultaneous detection of lower respiratory tract microbiota may also be useful for early diagnosis of infections. However, the use of lung microbiota in the perioperative period of lung transplantation in the setting of pulmonary infections is still at an exploratory stage. The present study is a prospective case-control study. Patients in the MICU after lung transplantation were enrolled, and alveolar lavage fluid was obtained within 48 hours of the patient's surgery, divided into aliquots, and subjected to macrogenomic sequencing, routine microbiological testing and cytokine testing. Patients were divided into pulmonary infection and non-pulmonary infection groups based on whether they had a co-infection at the time of sampling. Pulmonary infection was used as the primary study endpoint. To describe and compare the characteristics of the lung microbiota in the two groups and to determine whether variation in the lung microbiota could predict the development of lung infection and prognosis in patients in the early post-transplant period. To explore the diagnostic thresholds of common lung pathogens by macrogenomic sequencing in patients with co-infections in the early post-transplant period

Study Design

Study Type:
Observational
Anticipated Enrollment :
80 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Diagnostic and Prognostic Value of Lung Microbiota in Early Lung Infection After Lung Transplantation
Anticipated Study Start Date :
Nov 20, 2022
Anticipated Primary Completion Date :
Nov 30, 2023
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Pneumonia group

Patients in the MICU after lung transplantation were enrolled, and alveolar lavage fluid was obtained within 48 hours of the patient's surgery, divided into aliquots, and subjected to macrogenomic sequencing, routine microbiological testing and cytokine testing. Patients will be divided into pneumonia group if they had a co-infection at the time of sampling.

Diagnostic Test: metagenomic next-generation sequencing
Collection of bronchoalveolar lavage fluid
Other Names:
  • next-generation sequencing
  • control group

    Patients in the MICU after lung transplantation were enrolled, and alveolar lavage fluid was obtained within 48 hours of the patient's surgery, divided into aliquots, and subjected to macrogenomic sequencing, routine microbiological testing and cytokine testing. Patients will be divided into non-pulmonary infection (control)group if they had no co-infection at the time of sampling.

    Diagnostic Test: metagenomic next-generation sequencing
    Collection of bronchoalveolar lavage fluid
    Other Names:
  • next-generation sequencing
  • Outcome Measures

    Primary Outcome Measures

    1. Incidence of lung infection [Within 48 hours after surgery]

      Positive etiology, respiratory symptoms, new infiltrative shadow on chest imaging

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients admitted to the ICU for lung transplantation; consent for bronchoscopy; informed consent signed by the patient or their representative.
    Exclusion Criteria:
    • Patients admitted to ICU for other serious illnesses; patients more than 48 hours after lung transplantation; patients predicted to die within 48 hours; participation in other clinical studies; failure to sign an informed consent form.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Qingyuan Zhan

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Qingyuan Zhan, Head of Ward 4, Respiratory and Critical Care Medicine, China-Japan Friendship Hospital
    ClinicalTrials.gov Identifier:
    NCT05627505
    Other Study ID Numbers:
    • 2022-HX-53
    First Posted:
    Nov 25, 2022
    Last Update Posted:
    Nov 25, 2022
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 25, 2022