Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Wenzhou Central Hospital | OTHER |
| Red Cross Hospital, Hangzhou, China | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulmonary Tuberculosis Suspects | Individuals with suspected TB infection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRISPR-based Test | Diagnostic Test | CRISPR-based Test performed on sputum or BALF in TB suspects. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Suspected pulmonary TB patients in Huashan Hospital, Wenzhou Central Hospital and Hangzhou Red Cross Hospital.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenhong Zhang | Contact | (+86) 21 5288 7970 | zhangwenhong@fudan.edu.cn | |
| Jingwen Ai | Contact | (+86) 21 5288 7970 | jingwenai1990@126.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital | Recruiting | Shanghai | Shanghai Municipality | 200040 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33616229 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014397 | Tuberculosis, Pulmonary |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |