NCT02838641

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
219

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 20, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2017

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

1.5 years

First QC Date

July 18, 2016

Last Update Submit

April 16, 2019

Conditions

Observation

Outcome Measures

Primary Outcomes (1)

  • sensitivity, specificity, positive and negative predictive values

    18 months

Interventions

GeneXpertDEVICE

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients suspected of TB but both smear microscopy and TB PCR of sputum are negative or sputum cannot be produced

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Shatin, Hong Kong

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Honorary Clinical Assistant Professor

Study Record Dates

First Submitted

July 18, 2016

First Posted

July 20, 2016

Study Start

November 1, 2015

Primary Completion

April 30, 2017

Study Completion

April 30, 2017

Last Updated

April 17, 2019

Record last verified: 2019-04

Locations

HK(1)