Application of GeneXpert on Bronchoscopic Samples for Patients Suspicious of TB

Observation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02838641
• Other study ID #: 2014.556
• Status: Completed
• Start date: November 2015
• Est. completion date: April 30, 2017

Study information

• Verified date: April 2019
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 219
• Est. completion date: April 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.

Related Conditions & MeSH terms

• Observation

Intervention

Device:
• GeneXpert
Real time integrated and automated nucleic acid amplification test for detection of TB

Locations

Country	Name	City	State
Hong Kong	Department of Medicine and Therapeutics, Prince of Wales Hospital, CUHK	Shatin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sensitivity, specificity, positive and negative predictive values		18 months