Application of GeneXpert on Bronchoscopic Samples in the Clinical Management of Patients Suspicious of TB

Completed

• Conditions: Tuberculosis
• Interventions: Procedure: bronchoscopy

• Registration Number: NCT02619240
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-11-23
• Study First Submitted QC: 2015-11-30
• Study First Posted: 2015-12-02
• Primary Completion: 2017-04-30
• Study Completion: 2017-08-30
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-16
• Last Update Posted: 2019-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

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Exclusion Criteria

1. Bronchoscopy is not planned as a necessary procedure for investigation.
2. Diagnosis of active TB has been made by other means.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients suspected of TB	bronchoscopy	patients suspected of TB requiring to undergo bronchoscopy as part of the investigation

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Medicine and Therapeutics, Prince of Wales Hospital, CUHK; 🇭🇰 Shatin, Hong Kong