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

NCT04345939 — Unknown, 400 participants, Shanghai Pulmonary Hospital, Shanghai, China

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Rapid and Accurate Detection of Major Mycobacterium Species in Pulmonary

Registry	NCT04345939
Status	Unknown
Study type	Observational
Enrollment	400 (Estimated)
Sponsor	Shanghai Pulmonary Hospital, Shanghai, China (Other)
Conditions	Mycobacterium Pulmonary Infection
Interventions	Detection method (Diagnostic test)
Dates	start 2021-06-28, primary completion 2024-08-30 (estimated), completion 2024-08-30 (estimated), first posted 2020-04-15, last updated 2021-10-06
Locations	1 site in China

-Summary

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

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+Detailed 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)

+Arms and interventions

Arm	Interventions	Description
GenSeizer	Diagnostic Test: Detection method	Sputum and lavage fluids are tested for pathogens using GenSeizer
PCR reverse hybridization	Diagnostic Test: Detection method	Sputum and lavage fluids are tested for pathogens using PCR reverse hybridization
Target sequencing after incubation	Diagnostic Test: Detection method	Sputum and lavage fluids are tested for pathogens using Target sequencing after incubation

Detection method (Diagnostic test): Different methods for pathogen diagnosis

+Outcome measures

Primary outcomes

Detection accuracy [through study completion, an average of 3 years]

+Eligibility

Sex: All, ages: 16 Years to 70 Years

Inclusion Criteria:

* Suspected cases of mycobacterial lung infection

Exclusion Criteria:

* No sputum
* Refused or unable to tolerate bronchoscopy

+Locations (1)

Facility	City	Country	Status
Haiqing Chu	Shanghai	China	Recruiting