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

NCT05627505 | Unknown

• 1 other identifier: 2022-HX-53
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pneumonia

Outcome Measures

Primary Outcomes (1)

• Incidence of lung infection

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

  Within 48 hours after surgery

Study Arms (2)

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

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

Interventions

metagenomic next-generation sequencing DIAGNOSTIC_TEST

Collection of bronchoalveolar lavage fluid

Also known as: next-generation sequencing

Pneumonia group; control group

Eligibility Criteria

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

Study Population

Patients admitted to ICU after lung transplantation in China-Japan Friendship Hospital

You may qualify if:

• Patients admitted to the ICU for lung transplantation; consent for bronchoscopy; informed consent signed by the patient or their representative.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qingyuan Zhan: lead

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Yuhan Wu, Dr

CONTACT

18845145580; why20220509@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Ward 4, Respiratory and Critical Care Medicine

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: November 25, 2022
• Study Start: November 20, 2022
• Primary Completion: November 30, 2023
• Study Completion: December 30, 2023
• Last Updated: November 25, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share