Performance Study of Targeted Sequencing Technology for VAP

NCT06035796 | Unknown DMC

• 1 other identifier: Yuting Li111
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

VAP - Ventilator Associated Pneumonia

Outcome Measures

Primary Outcomes (1)

• tNGS for pathogen detection rate and drug resistance rate in VAP

  Evaluating the feasibility of tNGS for pathogen detection rate and drug resistance rate in VAP patients

  2years

Secondary Outcomes (1)

• Consistency rate of pathogen detection of tNGS with clinical practice

  2 years

Study Arms (2)

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

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.

Interventions

tNGS DEVICE

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.

tNGS(targeted second generation sequencing)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

VAP patients in the ICU

You may qualify if:

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

You may not qualify if:

• (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

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Related Publications (1)

• Li N, Ma X, Zhou J, Deng J, Gu C, Fei C, Cao L, Zhang Q, Tao F. 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. J Clin Lab Anal. 2022 Jul;36(7):e24498. doi: 10.1002/jcla.24498. Epub 2022 May 27.

  PMID: 35622934 RESULT

Related Links

• 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

Biospecimen

Retention: SAMPLES WITH DNA

BALF or sputum

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dong Zhang

  The First Hospital of Jilin University

  STUDY DIRECTOR

Central Study Contacts

Yuting Li

CONTACT

13943179756; liyuting@jlu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: September 13, 2023
• Study Start: October 1, 2023
• Primary Completion: October 1, 2025
• Study Completion: October 30, 2025
• Last Updated: September 13, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share