Trials / Completed
CompletedNCT02838641
Application of GeneXpert on Bronchoscopic Samples for Patients Suspicious of TB
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 219 (estimated)
- Sponsor
- Chinese University of Hong Kong · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
This is an 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | GeneXpert | Real time integrated and automated nucleic acid amplification test for detection of TB |
Timeline
- Start date
- 2015-11-01
- Primary completion
- 2017-04-30
- Completion
- 2017-04-30
- First posted
- 2016-07-20
- Last updated
- 2019-04-17
Locations
1 site across 1 country: Hong Kong
Source: ClinicalTrials.gov record NCT02838641. Inclusion in this directory is not an endorsement.