Clinical trial NCT06035796: Performance Study of Targeted Sequencing Technology for VAP
Official title: Performance Study of Targeted Sequencing Technology for Identification of Respiratory Pathogens and Drug Resistance Factor Analysis in VAP Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: VAP - Ventilator Associated Pneumonia
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: VAP patients in the ICU

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.

Eligibility criteria: 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

Primary outcomes:
measure: tNGS for pathogen detection rate and drug resistance rate in VAP
timeFrame: 2years
Secondary outcomes:
measure: Consistency rate of pathogen detection of tNGS with clinical practice
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: The First Hospital of Jilin University
name: Dong Zhang
role: STUDY_DIRECTOR
References:
citation: 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.