Skip to main content
OpenTrials
Completed

NCT Number: NCT02838641

Application of GeneXpert on Bronchoscopic Samples for Patients Suspicious of TB

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Observation

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Shatin, Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

GeneXpert

Device

Real time integrated and automated nucleic acid amplification test for detection of TB

Primary outcomes

  1. sensitivity, specificity, positive and negative predictive values

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 20, 2016
Registry last updated
Apr 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.