Performance Study of Targeted Sequencing Technology for VAP

Not yet recruiting

• Conditions: VAP - Ventilator Associated Pneumonia
• Interventions: Device: tNGS

• Registration Number: NCT06035796
• Lead Sponsor: The First Hospital of Jilin University

Brief 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.

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-08-25
• Study First Submitted QC: 2023-09-06
• Last Update Submitted: 2023-09-06
• Study First Posted: 2023-09-13
• Last Update Posted: 2023-09-13
• Study Start: 2023-10-01
• Primary Completion: 2025-10-01
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• (1)VAP patients (2) Patients can collect the required test information

Exclusion Criteria

• (1) Clearly diagnosed as non-infectious patients

  (2) Insufficient samples or patients unwilling to participate

  (3) Life expectancy is less than 24 hours

  (4) Patients' clinical information cannot be obtained

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
tNGS(targeted second generation sequencing)	tNGS	tNGS detection of lower respiratory tract samples (BALF) from VAP patients.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.

Primary Outcome Measures

Name	Time	Method
tNGS for pathogen detection rate and drug resistance rate in VAP	2years	Evaluating the feasibility of tNGS for pathogen detection rate and drug resistance rate in VAP patients

Secondary Outcome Measures

Name	Time	Method
Consistency rate of pathogen detection of tNGS with clinical practice	2 years	1. To compare the consistency rate of TNGs-based pathogen detection with clinical; culture, multiple clinical detection methods (PCR/ serology, etc.) and comprehensive diagnosis results in the whole and different types of microorganisms (bacteria/viruses/fungi); 2. To compare the consistency rate of drug resistance results of TNGs-based drug resistance gene test and clinical drug susceptibility test; 3. To compare the consistency rate of the responsible pathogen based on tNGS semi-quantitative judgment with the clinical comprehensive diagnosis results.