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

NCT07191080 | Enrolling By Invitation

• 1 other identifier: MSZ2023197
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Infection

Keywords

mNGS; tNGS; Severe lung infection

Outcome Measures

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

  The time from the enrollment test to the result ,usually within 48 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bin Zhang: lead

Study Sites (1)

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226006, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: September 24, 2025
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)