Performance Study of Targeted Sequencing Technology for VAP

Sponsor

The First Hospital of Jilin University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06035796

Collaborator

(none)

150

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
VAP - Ventilator Associated Pneumonia	Device: tNGS

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 Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2025

Anticipated Study Completion Date :

Oct 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
tNGS(targeted second generation sequencing) 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.	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.
non-tNGS(non-targeted second generation sequencing) 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.

Arm

Intervention/Treatment

tNGS(targeted second generation sequencing)

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.

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.

non-tNGS(non-targeted second generation sequencing)

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.

Outcome Measures

Primary Outcome Measures

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

Consistency rate of pathogen detection of tNGS with clinical practice [2 years]
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); To compare the consistency rate of drug resistance results of TNGs-based drug resistance gene test and clinical drug susceptibility test; To compare the consistency rate of the responsible pathogen based on tNGS semi-quantitative judgment with the clinical comprehensive diagnosis results.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

The First Hospital of Jilin University

Investigators

Study Director: Dong Zhang, The First Hospital of Jilin University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Clinical application of metagenomic next-generation sequencing technology in the diagnosis and treatment of pulmonary infection pathogens: A prospective single-center study of 138 patients

Publications

None provided.

Responsible Party:

The First Hospital of Jilin University

ClinicalTrials.gov Identifier:

NCT06035796

Other Study ID Numbers:

Yuting Li111

First Posted:

Sep 13, 2023

Last Update Posted:

Sep 13, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pneumonia, Ventilator-Associated

Study Results

No Results Posted as of Sep 13, 2023