VAP - Ventilator Associated PneumoniaNCT06035796
Performance Study of Targeted Sequencing Technology for VAP
An observational study of VAP - Ventilator Associated Pneumonia, run by The First Hospital of Jilin University.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- VAP - Ventilator Associated Pneumonia
- What is being tested?
- tNGS
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 30 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: VAP patients in the ICU
Who may be able to join
- (1)VAP patients (2) Patients can collect the required test information
Who cannot join
- (1) Clearly diagnosed as non-infectious patients
- Insufficient samples or patients unwilling to participate
- Life expectancy is less than 24 hours
- Patients' clinical information cannot be obtained
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Performance Study of Targeted Sequencing Technology for Identification of Respiratory Pathogens and Drug Resistance Factor Analysis in VAP Patients
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.
Read the 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.
- Conditions
- VAP - Ventilator Associated Pneumonia
- Being tested
- tNGS
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tNGSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2years
Secondary outcomes (1)
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start1 Oct 2023 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for VAP - Ventilator Associated PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dong Zhang, Study director, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06035796
- Sponsor's protocol ID
- Yuting Li111
- Status last verified
- Jul 2023
- First submitted
- 25 Aug 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35622934
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Study of Targeted Sequencing Technology for Identification of Respiratory Pathogens and Drug Resistance Factor Analysis in VAP Patients
- ClinicalTrials.gov ID
- NCT06035796
- Acronym / sponsor ID
- Yuting Li111
- Conditions
- VAP - Ventilator Associated Pneumonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tNGS(targeted second generation sequencing) | – | Device: tNGStNGS 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- VAP patients in the ICU
Key inclusion criteria (1 listed)
- (1)VAP patients (2) Patients can collect the required test information
Key exclusion criteria (4 listed)
- (1) Clearly diagnosed as non-infectious patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tNGSBy 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(targeted second generation sequencing) |
Primary outcome
tNGS for pathogen detection rate and drug resistance rate in VAP
Time frame: 2years
Evaluating the feasibility of tNGS for pathogen detection rate and drug resistance rate in VAP patients
1 secondary outcome
Consistency rate of pathogen detection of tNGS with clinical practice
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Results publication: PubMed 35622934Li 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.
- Clinical application of metagenomic next-generation sequencing technology in the diagnosis and treatment of pulmonary infection pathogens: A prospective single-center study of 138 patientsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dong Zhang study director
The First Hospital of Jilin University
Questions about this trial
What is this clinical trial studying?
An observational study of VAP - Ventilator Associated Pneumonia, run by The First Hospital of Jilin University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuting Li (13943179756, liyuting@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tNGS for pathogen detection rate and drug resistance rate in VAP (time frame: 2years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06035796, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.