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Prospective Assessment of TBDx Feasibility

Sponsor
Foundation for Innovative New Diagnostics, Switzerland (Other)
Overall Status
Completed
CT.gov ID
NCT02912832
Collaborator
(none)
572
Enrollment
2
Locations
1
Arm
10
Duration (Months)
286
Patients Per Site
28.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: TBDx
 N/A

Detailed Description

This will be a blinded, prospective study to determine the performance of the TBDx system for detection of pulmonary TB in comparison to LED microscopy and culture as a gold standard. The study will involve recruitment of 300 TB suspects per site with a high workload and experienced technicians. Participants will be recruited under the FIND TB Reference Materials project and leftover sputum samples used for the assessment of the TBDx.

Study Design

Study Type:
Interventional
Actual Enrollment :
572 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Diagnostic
Official Title:
TBDx Feasibility Study: Prospective Study to Determine the Feasibility of Automated Smear Microscopy
Study Start Date :
Oct 1, 2014
Actual Primary Completion Date :
Mar 1, 2015
Actual Study Completion Date :
Aug 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: TBDx

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
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.
Other Names:
  • Automated microscopy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Performance of TBDx compared to culture [6 months]

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

    Secondary Outcome Measures

    1. Training needs through questionnaire assessment [6 months]

      Two days of hands-on, onsite TBDx training was provided to laboratory technicians with prior experience using smear microscopy, followed by 1-day observation. Each operator performed 3-4 runs under supervision and a proficiency assessment was conducted prior to study initiation. Following study completion all technicians were given a survey to assess perception of training needs and ease of use.

    2. Comparison of performance of TBDx on direct vs concentrated smear [6 months]

    3. Performance of TBDx in combination with Xpert MTB/RIF through analysis of two different algorithms [6 months]

      The performance of an algorithm combining direct TBDx as a triage test, followed by Xpert for confirmation of positive TBDx cases for the different cut-off points was assessed

    4. User appraisal regarding ease of use, hands-on-time and perceived benefit through appraisal questionnaire [6 months]

    5. Identify potential difficulties for implementation through observation and user appraisal [6 months]

      Potential barriers for implementation were assessed through observation and appraisal questionnaires following study completion, taking into account total time, complexity, number of steps, etc.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    Exclusion Criteria:

    • Patients receiving any anti-TB medication, in the 60 days prior to testing.

    • Patients with only extra-pulmonary disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Instituto de Medicina Tropical Alexander von Humboldt - Universidad Peruana Cayetano Heredia Lima Peru
    2 Pham Ngoc Thach Hospital Ho Chi Minh City Vietnam

    Sponsors and Collaborators

    • Foundation for Innovative New Diagnostics, Switzerland

    Investigators

    • Study Director: Claudia M Denkinger, MD, Find

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Foundation for Innovative New Diagnostics, Switzerland
    ClinicalTrials.gov Identifier:
    NCT02912832
    Other Study ID Numbers:
    • 7012-05-3/1
    First Posted:
    Sep 23, 2016
    Last Update Posted:
    Sep 23, 2016
    Last Verified:
    Sep 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Foundation for Innovative New Diagnostics, Switzerland
    Diagnosis
    Additional relevant MeSH terms:
    Tuberculosis
    Tuberculosis, Pulmonary

    Study Results

    No Results Posted as of Sep 23, 2016