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

NCT ID: NCT04345939

Last Updated: 2021-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-28

Study Completion Date

2024-08-30

Brief Summary

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

Detailed Description

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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)

Conditions

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Mycobacterium Pulmonary Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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GenSeizer

Sputum and lavage fluids are tested for pathogens using GenSeizer

Detection method

Intervention Type DIAGNOSTIC_TEST

Different methods for pathogen diagnosis

PCR reverse hybridization

Sputum and lavage fluids are tested for pathogens using PCR reverse hybridization

Detection method

Intervention Type DIAGNOSTIC_TEST

Different methods for pathogen diagnosis

Target sequencing after incubation

Sputum and lavage fluids are tested for pathogens using Target sequencing after incubation

Detection method

Intervention Type DIAGNOSTIC_TEST

Different methods for pathogen diagnosis

Interventions

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Detection method

Different methods for pathogen diagnosis

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Suspected cases of mycobacterial lung infection

Exclusion Criteria

* No sputum
* Refused or unable to tolerate bronchoscopy
Minimum Eligible Age

16 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Pulmonary Hospital, Shanghai, China

OTHER

Sponsor Role lead

Responsible Party

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Haiqng Chu

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Haiqing Chu

Shanghai, , China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Haiqing Chu

Role: primary

+86 021 65115006-2109

Other Identifiers

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L20-203Y

Identifier Type: -

Identifier Source: org_study_id

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