Performance Study of Targeted Sequencing Technology for VAP

Jilin University

Status: Not yet enrolling

Conditions: VAP - Ventilator Associated Pneumonia

Treatments: Device: tNGS

Study type: Observational

Funder types: Other

Identifiers

NCT06035796

Yuting Li111

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

150 participants in 2 patient groups

tNGS(targeted second generation sequencing)

Description:

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.

Treatment:

Device: tNGS

non-tNGS(non-targeted second generation sequencing)

Description:

Perform routine clinical 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.