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Performance Study of Targeted Sequencing Technology for Identification of Respiratory Pathogens and Drug Resistance Factor Analysis in VAP Patients
Main purpose: To evaluate the feasibility of tNGS for pathogen detection and drug resistance analysis in VAP patients. Research site and research population: This study is planned to be conducted in hospitals, targeting VAP patients. Perform clinical routine testing and tNGS testing on lower respiratory tract samples (BALF) from VAP patients, and collect patient clinical information. Clinical routine testing includes culture (necessary), microscopy, serology, PCR, etc., and drug sensitivity tests are conducted on positive culture samples as needed. Finally, compare the consistency of tNGS detection results with clinical culture, comprehensive diagnosis, and drug sensitivity results. Further validation was conducted on consistent negative or inconsistent samples through PCR and mNGS.
The investigators plan to include 150 VAP patients in the ICU. Lower respiratory tract samples (BALF) from VAP patients were routinely tested and tNGS tested, and clinical information was collected. Routine clinical tests include culture (necessary), microscopic examination, serology, PCR, etc., and drug sensitivity tests are performed on positive culture samples as required. Finally, the consistency of tNGS test results with clinical culture, comprehensive diagnosis and drug sensitivity results was compared. The uniformly negative or inconsistent samples were further verified by PCR and mNGS.
Age
All ages
Sex
ALL
Healthy Volunteers
No
Start Date
October 1, 2023
Primary Completion Date
October 1, 2025
Completion Date
October 30, 2025
Last Updated
September 13, 2023
150
ESTIMATED participants
tNGS
DEVICE
Lead Sponsor
The First Hospital of Jilin University
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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View ClinicalTrials.gov Terms and ConditionsNCT05230472