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

• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04345939
• Collaborator: (none)
• Enrollment: 400
• Location: 1
• Anticipated Duration (Months): 38.1
• Patients Per Site Per Month: 10.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Mycobacterium Pulmonary Infection	Diagnostic Test: Detection method

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)

Study Design

• Study Type: Observational
• Anticipated Enrollment: 400 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Rapid and Accurate Detection of Major Mycobacterium Species in Pulmonary
• Actual Study Start Date: Jun 28, 2021
• Anticipated Primary Completion Date: Aug 30, 2024
• Anticipated Study Completion Date: Aug 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
GenSeizer Sputum and lavage fluids are tested for pathogens using GenSeizer	Diagnostic Test: Detection method; Different methods for pathogen diagnosis
PCR reverse hybridization Sputum and lavage fluids are tested for pathogens using PCR reverse hybridization	Diagnostic Test: Detection method; Different methods for pathogen diagnosis
Target sequencing after incubation Sputum and lavage fluids are tested for pathogens using Target sequencing after incubation	Diagnostic Test: Detection method; Different methods for pathogen diagnosis

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Suspected cases of mycobacterial lung infection

Exclusion Criteria:

• No sputum

• Refused or unable to tolerate bronchoscopy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Haiqing Chu	Shanghai		China

Sponsors and Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Haiqng Chu, Director, Shanghai Pulmonary Hospital, Shanghai, China
• ClinicalTrials.gov Identifier: NCT04345939
• Other Study ID Numbers: L20-203Y
• First Posted: Apr 15, 2020
• Last Update Posted: Oct 6, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infections; Mycobacterium Infections

Study Results

No Results Posted as of Oct 6, 2021