- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05627505
Diagnostic and Prognostic Value of Lung Microbiota in Early Lung Infection After Lung Transplantation
November 23, 2022 updated by: Qingyuan Zhan
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yuhan Wu, Dr
- Phone Number: 18845145580
- Email: why20220509@163.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients admitted to ICU after lung transplantation in China-Japan Friendship Hospital
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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.
|
Collection of bronchoalveolar lavage fluid
Other Names:
|
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.
|
Collection of bronchoalveolar lavage fluid
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of lung infection
Time Frame: Within 48 hours after surgery
|
Positive etiology, respiratory symptoms, new infiltrative shadow on chest imaging
|
Within 48 hours after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
November 20, 2022
Primary Completion (Anticipated)
November 30, 2023
Study Completion (Anticipated)
December 30, 2023
Study Registration Dates
First Submitted
November 17, 2022
First Submitted That Met QC Criteria
November 23, 2022
First Posted (Actual)
November 25, 2022
Study Record Updates
Last Update Posted (Actual)
November 25, 2022
Last Update Submitted That Met QC Criteria
November 23, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-HX-53
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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