NCT06035796

Performance Study of Targeted Sequencing Technology for VAP

Performance Study of Targeted Sequencing Technology for Identification of Respiratory Pathogens and Drug Resistance Factor Analysis in VAP Patients

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: The First Hospital of Jilin University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• VAP - Ventilator Associated Pneumonia

Interventions

Type	Name	Description
DEVICE	tNGS	By means of super-multiple PCR amplification or probe hybridization capture, tNGS can enrich dozens to hundreds of known pathogenic microorganisms and their virulence and drug resistance genes in the samples to be tested, and then conduct high-throughput sequencing.

Timeline

• Start date: 2023-10-01
• Primary completion: 2025-10-01
• Completion: 2025-10-30
• First posted: 2023-09-13
• Last updated: 2023-09-13