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

NCT02619240 | Completed

• 1 other identifier: CREC 2014.556
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

patients suspected of TB

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

Procedure: bronchoscopy

Interventions

bronchoscopy PROCEDURE

performance of bronchoscopy with BAL

patients suspected of TB

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adult patients with abnormal chest imaging suspected of TB as a differential diagnosis

You may qualify if:

• Patients \> 18 years old suspected of TB clinically.
• Patients suspected of TB but both smear microscopy and TB PCR of sputum are negative or sputum cannot be produced.
• BAL samples obtained following standard investigation procedure
• CXR or CT imaging available.

You may not qualify if:

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Medicine and Therapeutics, Prince of Wales Hospital, CUHK

Shatin, Hong Kong

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

bronchoscopic alveolar lavage

MeSH Terms

Conditions

Tuberculosis

Interventions

Bronchoscopy

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Kin Wang To, MBChB

  Honoary clinical assistant professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: November 23, 2015
• First Posted: December 2, 2015
• Study Start: October 1, 2015
• Primary Completion: April 30, 2017
• Study Completion: August 30, 2017
• Last Updated: April 17, 2019

Record last verified: 2019-04

Locations

HK (1)