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

Rapid and Accurate Detection of Major Mycobacterium Species in Pulmonary

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

Study Overview

• Status: Recruiting
• Conditions: Mycobacterium Pulmonary Infection
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Haiqing Chu
    • Contact: Haiqing Chu; Phone Number: +86 021 65115006-2109; Email: chu_haiqing@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Suspected cases of mycobacterial lung infection

Description

Inclusion Criteria:

• Suspected cases of mycobacterial lung infection

Exclusion Criteria:

• No sputum
• Refused or unable to tolerate bronchoscopy

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Detection accuracy	through study completion, an average of 3 years

Collaborators and Investigators

• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2021
• Primary Completion (Anticipated): August 30, 2024
• Study Completion (Anticipated): August 30, 2024

Study Registration Dates

• First Submitted: April 10, 2020
• First Submitted That Met QC Criteria: April 13, 2020
• First Posted (Actual): April 15, 2020

Study Record Updates

• Last Update Posted (Actual): October 6, 2021
• Last Update Submitted That Met QC Criteria: September 29, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Infections; Mycobacterium Infections
• Other Study ID Numbers: L20-203Y

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No