Performance Study of Targeted Sequencing Technology for VAP

VAP - Ventilator Associated Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06035796
• Other study ID #: Yuting Li111
• Status: Not yet recruiting
• Start date: October 1, 2023
• Est. completion date: October 30, 2025

Study information

• Verified date: July 2023
• Source: The First Hospital of Jilin University
• Contact: Yuting Li
• Phone: 13943179756
• Email: liyuting[@]jlu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: October 30, 2025
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia, Ventilator-Associated
• VAP - Ventilator Associated Pneumonia

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The First Hospital of Jilin University

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Consistency rate of pathogen detection of tNGS with clinical practice	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.	2 years

External 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