Clinical Trials Directory

Trials / Unknown

UnknownNCT05627505

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

Status
Unknown
Phase
Study type
Observational
Enrollment
80 (estimated)
Sponsor
Qingyuan Zhan · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

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

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTmetagenomic next-generation sequencingCollection of bronchoalveolar lavage fluid

Timeline

Start date
2022-11-20
Primary completion
2023-11-30
Completion
2023-12-30
First posted
2022-11-25
Last updated
2022-11-25

Source: ClinicalTrials.gov record NCT05627505. Inclusion in this directory is not an endorsement.