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

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ClinicalTrials.gov Identifier: NCT04074369
Recruitment Status : Unknown
Verified August 2019 by Wen-hong Zhang, Huashan Hospital.
Recruitment status was:  Recruiting
First Posted : August 30, 2019
Last Update Posted : August 30, 2019
Sponsor:
Collaborators:
Wenzhou Central Hospital
Hangzhou Red Cross Hospital
Information provided by (Responsible Party):
Wen-hong Zhang, Huashan Hospital

Tracking Information
First Submitted Date August 28, 2019
First Posted Date August 30, 2019
Last Update Posted Date August 30, 2019
Actual Study Start Date May 1, 2019
Estimated Primary Completion Date October 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 28, 2019)
  • 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. [ Time Frame: 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. [ Time Frame: week 0 ]
  • Proportion of clinically diagnosed non-TB participants with CRISPR-based test MTB positive in sputum/BALF. [ Time Frame: week 0 ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of CRISPR-based Test for the Rapid Identification of TB in Pulmonary Tuberculosis Suspects
Official Title Evaluation of CRISPR-based Test for the Rapid Identification of Mycobacterium Tuberculosis Complex in Pulmonary Tuberculosis Suspects
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.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 2 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Suspected pulmonary TB patients in Huashan Hospital, Wenzhou Central Hospital and Hangzhou Red Cross Hospital.
Condition Tuberculosis, Pulmonary
Intervention Diagnostic Test: CRISPR-based Test
CRISPR-based Test performed on sputum or BALF in TB suspects.
Study Groups/Cohorts Pulmonary Tuberculosis Suspects
Individuals with suspected TB infection
Intervention: Diagnostic Test: CRISPR-based Test
Publications * 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:CD009593. doi: 10.1002/14651858.CD009593.pub5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: August 28, 2019)
800
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 30, 2019
Estimated Primary Completion Date October 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT04074369
Other Study ID Numbers 20190601
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Wen-hong Zhang, Huashan Hospital
Study Sponsor Huashan Hospital
Collaborators
  • Wenzhou Central Hospital
  • Hangzhou Red Cross Hospital
Investigators Not Provided
PRS Account Huashan Hospital
Verification Date August 2019