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Enrolling by invitationNCT07191080Updated Sep 24, 2025

Next-generation Sequencing Technology in the Clinical Application of Respiratory Specimens

An observational study in Lung Infection, sponsored by Bin Zhang. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-24.

Sponsored by Bin Zhang · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Lung Infection

Keywords

  • mNGS
  • tNGS
  • Severe lung infection
03

In context

Lead sponsor

Bin Zhang is the lead sponsor of 4 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with severe pulmonary infections from the Affiliated Hospital of Nantong University.

Inclusion criteria

  1. Voluntary signing of the informed consent form.
  2. 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.
  3. Sufficient samples can be obtained.
  4. Patients with complete clinical data.

Exclusion criteria

Exclusion Criteria:

  1. Refusal to sign informed consent.
  2. Testing has clearly excluded infection.
  3. Received antibiotic treatment within three days prior to testing without stopping the medication for more than 12 hours.
  4. Sample quality is not up to standard.
  5. Unable to obtain sufficient sample.
  6. No complete drug usage history.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 site
  • Affiliated Hospital of Nantong University
    Nantong, Jiangsu 226006, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07191080
Lead sponsor
Bin Zhang
Responsible party
Bin Zhang (Chief physician, Affiliated Hospital of Nantong University) — Sponsor-investigator
First posted
Sep 24, 2025
Start date
Oct 1, 2024
Primary completion
Oct 1, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Sep 24, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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