Evaluation of CRISPR-based Test for the Rapid Identification of TB in Pulmonary Tuberculosis Suspects
1 other identifier
observational
800
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2019
CompletedFirst Submitted
Initial submission to the registry
August 28, 2019
CompletedFirst Posted
Study publicly available on registry
August 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2019
CompletedAugust 30, 2019
August 1, 2019
6 months
August 28, 2019
August 28, 2019
Conditions
Outcome Measures
Primary Outcomes (3)
Proportion of clinically diagnosed TB participants with CRISPR-based test MTB positive in sputum/BALF who are Xpert MTB/RIF Assay positive and/or MGIT culture positive for M.tuberculosis.
week 0
Proportion of clinically diagnosed TB participants with CRISPR-based test MTB positive in sputum/BALF who are Xpert MTB/RIF Assay negative and/or MGIT culture negative for M.tuberculosis.
week 0
Proportion of clinically diagnosed non-TB participants with CRISPR-based test MTB positive in sputum/BALF.
week 0
Study Arms (1)
Pulmonary Tuberculosis Suspects
Individuals with suspected TB infection
Interventions
CRISPR-based Test performed on sputum or BALF in TB suspects.
Eligibility Criteria
Suspected pulmonary TB patients in Huashan Hospital, Wenzhou Central Hospital and Hangzhou Red Cross Hospital.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Huashan Hospitallead
- Wenzhou Central Hospitalcollaborator
- Red Cross Hospital, Hangzhou, Chinacollaborator
Study Sites (1)
Huashan Hospital
Shanghai, Shanghai Municipality, 200040, China
Related Publications (1)
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.
PMID: 33616229DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Division of Infectious Diseases
Study Record Dates
First Submitted
August 28, 2019
First Posted
August 30, 2019
Study Start
May 1, 2019
Primary Completion
October 30, 2019
Study Completion
October 30, 2019
Last Updated
August 30, 2019
Record last verified: 2019-08