Lung InfectionNCT07191080
Next-generation Sequencing Technology in the Clinical Application of Respiratory Specimens
An observational study of Lung Infection, run by Bin Zhang at 1 site in China.
Trial summary
Obtain the performance parameters and clinical consistency of mNGS and tNGS technologies in the pathogen diagnosis of lower respiratory tract specimens from patients with severe pulmonary infections, to provide a reference basis for the application value and true performance of these technologies in the pathogen… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Infection
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with severe pulmonary infections from the Affiliated Hospital of Nantong University.
Who may be able to join
- Voluntary signing of the informed consent form.
- Common respiratory infections: traditional methods cannot clearly identify and the patient's condition is prolonged without improvement; Patients with a high suspicion of viral pneumonia: such as acute onset during a season of high viral incidence, normal or low blood leukocyte counts, rapid disease progression, negative results for respiratory viral multiplex PCR testing and cultures; Immunocompromised patients: experiencing respiratory infections or severe illness.
- Sufficient samples can be obtained.
- Patients with complete clinical data.
Who cannot join
- Refusal to sign informed consent.
- Testing has clearly excluded infection.
- Received antibiotic treatment within three days prior to testing without stopping the medication for more than 12 hours.
- Sample quality is not up to standard.
- Unable to obtain sufficient sample.
- No complete drug usage history.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Application of Respiratory Specimens mNGS and tNGS in Aetiological Diagnosis
Obtain the performance parameters and clinical consistency of mNGS and tNGS technologies in the pathogen diagnosis of lower respiratory tract specimens from patients with severe pulmonary infections, to provide a reference basis for the application value and true performance of these technologies in the pathogen diagnosis of patients with severe pulmonary infections.
Read the detailed description
Compared with pathogenic mNGS detection of lower respiratory tract airway secretion specimens, pathogenic tNGS detection can further shorten the detection time.It can more accurately analyze the pathogen composition of the patient's lower respiratory tract infectious diseases and identify the diagnostic results of the pathogen of lower respiratory tract infections.It also has a very high accuracy in identifying atypical special pathogens such as fastidious bacteria, fungi and viruses.
This study plans to enroll patients with severe pulmonary infection admitted to the Affiliated Hospital of Nantong University, and collect samples of alveolar lavage fluid or sputum specimens collected by the airway specification from the patients will be sent for testing of mNGS and tNGS, the results obtained from different methodological tests will be compared and analyzed, and the clinical data of patients (including basic information of patients (including gender, age, height, weight, past medical history, etc.), traditional pathogen testing, G/GM experiments, blood routine, PCT, CRP, CD4 lymphocytes, IFN, IL-6, IL-2 and serum antigen detection, clinical antimicrobial drug use, imaging examination, etc.) will be collected through the electronic medical record system. The test results will be analyzed and compared with the clinical condition of the patients, and finally the detection performance of mNGS and tNGS will be obtained.
- Conditions
- Lung Infection
- Keywords
- mNGS, tNGS, Severe lung infection
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison the results of the microbial detection rates of mNGS and tNGS、the number of strains detected and the type number of species detected
Measured: The time from the enrollment test to the result ,usually within 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start1 Oct 2024
- Primary completion1 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung InfectionStudies 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bin Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bin Zhang, Affiliated Hospital of Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07191080
- Sponsor's protocol ID
- MSZ2023197
- Status last verified
- Sep 2025
- First submitted
- 21 Jul 2025
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Respiratory Specimens mNGS and tNGS in Aetiological Diagnosis
- ClinicalTrials.gov ID
- NCT07191080
- Acronym / sponsor ID
- MSZ2023197
- Conditions
- Lung Infection
- Keywords
- mNGS, tNGS, Severe lung infection
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Bin ZhangUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 Sep 2025 (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.
Obtain the performance parameters and clinical consistency of mNGS and tNGS technologies in the pathogen diagnosis of lower respiratory tract specimens from patients with severe pulmonary infections, to provide a reference basis for the application value and true performance of these technologies in the pathogen diagnosis of patients with severe pulmonary infections.
Detailed description
Compared with pathogenic mNGS detection of lower respiratory tract airway secretion specimens, pathogenic tNGS detection can further shorten the detection time.It can more accurately analyze the pathogen composition of the patient's lower respiratory tract infectious diseases and identify the diagnostic results of the pathogen of lower respiratory tract infections.It also has a very high accuracy in identifying atypical special pathogens such as fastidious bacteria, fungi and viruses.
This study plans to enroll patients with severe pulmonary infection admitted to the Affiliated Hospital of Nantong University, and collect samples of alveolar lavage fluid or sputum specimens collected by the airway specification from the patients will be sent for testing of mNGS and tNGS, the results obtained from different methodological tests will be compared and analyzed, and the clinical data of patients (including basic information of patients (including gender, age, height, weight, past medical history, etc.), traditional pathogen testing, G/GM experiments, blood routine, PCT, CRP, CD4 lymphocytes, IFN, IL-6, IL-2 and serum antigen detection, clinical antimicrobial drug use, imaging examination, etc.) will be collected through the electronic medical record system. The test results will be analyzed and compared with the clinical condition of the patients, and finally the detection performance of mNGS and tNGS will be obtained.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe pulmonary infections from the Affiliated Hospital of Nantong University.
Key inclusion criteria (4 listed)
- Voluntary signing of the informed consent form.
- Common respiratory infections: traditional methods cannot clearly identify and the patient's condition is prolonged without improvement; Patients with a high suspicion of viral pneumonia: such as acute onset during a season of high viral incidence, normal or low blood leukocyte counts, rapid disease progression, negative results for respiratory viral multiplex PCR testing and cultures; Immunocompromised patients: experiencing respiratory infections or severe illness.
- Sufficient samples can be obtained.
- Patients with complete clinical data.
Key exclusion criteria (6 listed)
- Refusal to sign informed consent.
- Testing has clearly excluded infection.
- Received antibiotic treatment within three days prior to testing without stopping the medication for more than 12 hours.
- Sample quality is not up to standard.
- Unable to obtain sufficient sample.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison the results of the microbial detection rates of mNGS and tNGS、the number of strains detected and the type number of species detected
Time frame: The time from the enrollment test to the result ,usually within 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Infection, run by Bin Zhang at 1 site in China.
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 4 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison the results of the microbial detection rates of mNGS and tNGS、the number of strains detected and the type number of species detected (time frame: The time from the enrollment test to the result ,usually within 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Sep 2025.