Tuberculosis Clinical Trial
Official title:
Application of GeneXpert on Bronchoscopic Samples in the Clinical Management of Patients Suspicious of TB
NCT number | NCT02619240 |
Other study ID # | CREC 2014.556 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 2015 |
Est. completion date | August 30, 2017 |
Verified date | April 2019 |
Source | Chinese University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This is a case control observational study using Bronchial-alveolar lavage (BAL) as specimen for GeneXpert, a real time polymerase chain reaction (PCR) test for detection of tuberculosis (TB). Patients suspicious of TB, who require bronchoscopy as part of the investigation procedures, will be recruited for this study over a period of 18 months. Clinical likelihood of TB will be systematically scored according to various clinical parameters. This will determine the pre-test probability. Clinician will decide if anti-TB treatment is to be started and patients will be followed up for a minimal of 18 months. Sensitivity, specificity, positive, negative predictive values and the respective likelihood ratio will be calculated accordingly.
Status | Completed |
Enrollment | 200 |
Est. completion date | August 30, 2017 |
Est. primary completion date | April 30, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: 1. Patients > 18 years old suspected of TB clinically. 2. Patients suspected of TB but both smear microscopy and TB PCR of sputum are negative or sputum cannot be produced. 3. BAL samples obtained following standard investigation procedure 4. CXR or CT imaging available. Exclusion Criteria: 1. Bronchoscopy is not planned as a necessary procedure for investigation. 2. Diagnosis of active TB has been made by other means. |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Department of Medicine and Therapeutics, Prince of Wales Hospital, CUHK | Shatin |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The number of true positive BAL PCR using GeneXpert on BAL for rapid diagnosis of TB in few hours compare to the conventional TB PCR which usually take up few days to perform | 1 year |
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