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Trial record 3 of 14 for:    CRISPR | China

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 : 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

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.

Condition or disease Intervention/treatment
Tuberculosis, Pulmonary Diagnostic Test: CRISPR-based Test

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Months
Official Title: Evaluation of CRISPR-based Test for the Rapid Identification of Mycobacterium Tuberculosis Complex in Pulmonary Tuberculosis Suspects
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : October 30, 2019
Estimated Study Completion Date : October 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Group/Cohort Intervention/treatment
Pulmonary Tuberculosis Suspects
Individuals with suspected TB infection
Diagnostic Test: CRISPR-based Test
CRISPR-based Test performed on sputum or BALF in TB suspects.




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Proportion of clinically diagnosed non-TB participants with CRISPR-based test MTB positive in sputum/BALF. [ Time Frame: week 0 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Suspected pulmonary TB patients in Huashan Hospital, Wenzhou Central Hospital and Hangzhou Red Cross Hospital.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04074369


Contacts
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Contact: Wenhong Zhang (+86) 21 5288 7970 zhangwenhong@fudan.edu.cn
Contact: Jingwen Ai (+86) 21 5288 7970 jingwenai1990@126.com

Locations
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China, Shanghai
Huashan Hospital Recruiting
Shanghai, Shanghai, China, 200040
Contact: Jing-wen Ai    (+86) 21 5288 7970    jingwenai1990@126.com   
Contact: Xian Zhou    (+86) 21 5288 7970 ext Zhou    zhouxianhz@gmail.com   
Sponsors and Collaborators
Huashan Hospital
Wenzhou Central Hospital
Hangzhou Red Cross Hospital

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Responsible Party: Wen-hong Zhang, Director of Division of Infectious Diseases, Huashan Hospital
ClinicalTrials.gov Identifier: NCT04074369     History of Changes
Other Study ID Numbers: 20190601
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tuberculosis
Tuberculosis, Pulmonary
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections