Evaluation of CRISPR-based Test for the Rapid Identification of TB in Pulmonary Tuberculosis Suspects

NCT ID: NCT04074369

Last Updated: 2019-08-30

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

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-01

Study Completion Date

2019-10-30

Brief Summary

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This observational Mycobacterium tuberculosis (MTB) diagnostics evaluation study is a prospective study of pulmonary TB suspects who are undergoing sputum or bronchoalveolar lavage fluid (BALF) evaluation for pulmonary TB. The sensitivity and specificity of the CRISPR-based assay will be compared to clinical diagnosis, conventional culture methods and Xpert MTB/RIF assay on same batch specimens.

Detailed Description

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Conditions

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Tuberculosis, Pulmonary

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pulmonary Tuberculosis Suspects

Individuals with suspected TB infection

CRISPR-based Test

Intervention Type DIAGNOSTIC_TEST

CRISPR-based Test performed on sputum or BALF in TB suspects.

Interventions

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CRISPR-based Test

CRISPR-based Test performed on sputum or BALF in TB suspects.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Suspected pulmonary TB.
* Ability and willingness of candidate or legal guardian/representative to provide informed consent.
* Men and women age equal to or greater than 18 years.

Exclusion Criteria

* Either receipt of ≥48 cumulative hours OR three or more doses of anti-TB treatment within 180 days prior to completion of second sputum collection for Xpert testing
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wenzhou Central Hospital

OTHER

Sponsor Role collaborator

Red Cross Hospital, Hangzhou, China

OTHER

Sponsor Role collaborator

Huashan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wen-hong Zhang

Director of Division of Infectious Diseases

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Huashan Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wenhong Zhang

Role: CONTACT

Phone: (+86) 21 5288 7970

Email: [email protected]

Jingwen Ai

Role: CONTACT

Phone: (+86) 21 5288 7970

Email: [email protected]

Facility Contacts

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Jing-wen Ai

Role: primary

Xian Zhou

Role: backup

References

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Zifodya JS, Kreniske JS, Schiller I, Kohli M, Dendukuri N, Schumacher SG, Ochodo EA, Haraka F, Zwerling AA, Pai M, Steingart KR, Horne DJ. Xpert Ultra versus Xpert MTB/RIF for pulmonary tuberculosis and rifampicin resistance in adults with presumptive pulmonary tuberculosis. Cochrane Database Syst Rev. 2021 Feb 22;2(2):CD009593. doi: 10.1002/14651858.CD009593.pub5.

Reference Type DERIVED
PMID: 33616229 (View on PubMed)

Other Identifiers

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20190601

Identifier Type: -

Identifier Source: org_study_id