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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04345939
Other study ID # L20-203Y
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 28, 2021
Est. completion date August 30, 2024

Study information

Verified date September 2021
Source Shanghai Pulmonary Hospital, Shanghai, China
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Comparison of rapid detection methods of mycobacterial pathogens, GenSeizer v.s. PCR reverse hybridization.


Description:

The investigators developed a new platform called GenSeizer, which combines bioinformatics analysis of a large dataset with multiplex PCR-based targeted gene sequencing, to identify eleven major Mycobacterium species implicated in human disease. Simultaneous detection of certain antibiotic resistance genotypes, i.e., erm(41) and rrl in M. abscessus, is also feasible. This platform detected both reference strains and clinical isolates with a high degree of specificity and sensitivity. In this study, the investigators plan to verify the detection efficiency of GenSeizer in clinical samples (sputum, alveolar lavage fluid) and compare it with existing methods on the market (PCR reverse hybridization) and gold standard method (target sequencing after incubation)


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date August 30, 2024
Est. primary completion date August 30, 2024
Accepts healthy volunteers No
Gender All
Age group 16 Years to 70 Years
Eligibility Inclusion Criteria: - Suspected cases of mycobacterial lung infection Exclusion Criteria: - No sputum - Refused or unable to tolerate bronchoscopy

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Detection method
Different methods for pathogen diagnosis

Locations

Country Name City State
China Haiqing Chu Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Pulmonary Hospital, Shanghai, China

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Detection accuracy through study completion, an average of 3 years