Rapid and Accurate Detection of Major Mycobacterium Species in Pulmonary Infection Based on GenSeizer Platform

Mycobacterium Pulmonary Infection Clinical Trial

Official title:

Rapid and Accurate Detection of Major Mycobacterium Species in Pulmonary

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04345939
• Other study ID #: L20-203Y
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Infections
• Mycobacterium Infections
• Mycobacterium Pulmonary Infection

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