NCT02912832

Brief Summary

The purpose of this study will be to determine the performance characteristics of TBDx with culture as a gold standard. In addition, the investigators will assess the laboratory technicians' appraisal and technical suitability of the TBDx system.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
572

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Shorter than P25 for not_applicable

Geographic Reach
2 countries

2 active sites

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

October 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 23, 2016

Completed
Last Updated

September 23, 2016

Status Verified

September 1, 2016

Enrollment Period

5 months

First QC Date

September 9, 2016

Last Update Submit

September 21, 2016

Conditions

Pulmonary Tuberculosis

Keywords

Diagnosis

Outcome Measures

Primary Outcomes (1)

  • Performance of TBDx compared to culture

    Sensitivity, specificity and predictive values of TBDx compared to two solid (Löwenstein Jensen) and two liquid (MGIT) cultures

    6 months

Secondary Outcomes (5)

  • Training needs through questionnaire assessment

    6 months

  • Comparison of performance of TBDx on direct vs concentrated smear

    6 months

  • Performance of TBDx in combination with Xpert MTB/RIF through analysis of two different algorithms

    6 months

  • User appraisal regarding ease of use, hands-on-time and perceived benefit through appraisal questionnaire

    6 months

  • Identify potential difficulties for implementation through observation and user appraisal

    6 months

Study Arms (1)

TBDx

EXPERIMENTAL

All samples were tested with TBDx and compared with smear microscopy and Xpert MTB/RIF using solid and liquid culture as gold standard. Operators were blinded to all other results for a sample upon data entry.

Device: TBDx

Interventions

TBDxDEVICE

The TBDx is an automated platform is based on an Olympus BX41 microscope with a 40 x objective lens, fitted with an Olympus XC 10 colour camera and a movable slide stage, with an attached computer that receives high-quality digital images acquired from the camera. The computer then operates detection algorithms that segment, evaluate, and classify objects of interest in these images which can be stored for subsequent review. The platform is able to integrate an optional 200-slide automated slide loader for high volume settings. The application can capture 100, 300 or more digital fields-of-view and can provide results for positive or negative smears in 5 minutes or less.

Also known as: Automated microscopy
TBDx

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Persistent cough (\>2 weeks) and at least one other typical symptom of pulmonary TB (fever, night sweats, malaise, recent weight loss, contact with active case, hemoptysis, chest pain, loss of appetite)
  • Provision of informed consent (FIND TB Reference Materials)
  • Provision of sputum for adequate testing

You may not qualify if:

  • Patients receiving any anti-TB medication, in the 60 days prior to testing.
  • Patients with only extra-pulmonary disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Instituto de Medicina Tropical Alexander von Humboldt - Universidad Peruana Cayetano Heredia

Lima, Peru

Location

Pham Ngoc Thach Hospital

Ho Chi Minh City, Vietnam

Location

Related Links

MeSH Terms

Conditions

Tuberculosis, PulmonaryDisease

Condition Hierarchy (Ancestors)

TuberculosisMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Claudia M Denkinger, MD

    Find

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2016

First Posted

September 23, 2016

Study Start

October 1, 2014

Primary Completion

March 1, 2015

Study Completion

August 1, 2015

Last Updated

September 23, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will share

De-identified patient and results dataset will be made available upon publication of study findings

Locations

VN(1)PE(1)