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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Consistency rate of pathogen detection of tNGS with clinical practice |
|
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Inclusion Criteria:
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
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VAP patients in the ICU
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuting Li | Contact | 13943179756 | liyuting@jlu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Dong Zhang | The First Hospital of Jilin University | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35622934 | Result | 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. |
| Label | URL |
|---|---|
| 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 | View source |
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| ID | Term |
|---|---|
| D053717 | Pneumonia, Ventilator-Associated |
| ID | Term |
|---|---|
| D000077299 | Healthcare-Associated Pneumonia |
| D003428 | Cross Infection |
| D007239 | Infections |
| D011014 | Pneumonia |
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BALF or sputum
|
| 2 years |
| D012141 |
| Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |