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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05627505
Enrollment
80
Registered
2022-11-25
Start date
2022-11-20
Completion date
2023-12-30
Last updated
2022-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumonia

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.

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

Interventions

Collection of bronchoalveolar lavage fluid

Sponsors

Qingyuan Zhan
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of lung infectionWithin 48 hours after surgeryPositive etiology, respiratory symptoms, new infiltrative shadow on chest imaging

Contacts

Primary ContactYuhan Wu, Dr
why20220509@163.com18845145580

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026