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Prospective Assessment of TBDx Feasibility

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02912832
Recruitment Status : Completed
First Posted : September 23, 2016
Last Update Posted : September 23, 2016
Information provided by (Responsible Party):
Foundation for Innovative New Diagnostics, Switzerland

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
Pulmonary Tuberculosis Device: TBDx Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : October 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : August 2015

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 Name: Automated microscopy

Primary Outcome Measures :
  1. Performance of TBDx compared to culture [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 6 months ]
  3. Performance of TBDx in combination with Xpert MTB/RIF through analysis of two different algorithms [ Time Frame: 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 [ Time Frame: 6 months ]
  5. Identify potential difficulties for implementation through observation and user appraisal [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02912832

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Instituto de Medicina Tropical Alexander von Humboldt - Universidad Peruana Cayetano Heredia
Lima, Peru
Pham Ngoc Thach Hospital
Ho Chi Minh City, Vietnam
Sponsors and Collaborators
Foundation for Innovative New Diagnostics, Switzerland
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Study Director: Claudia M Denkinger, MD Find
Additional Information:
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Responsible Party: Foundation for Innovative New Diagnostics, Switzerland Identifier: NCT02912832    
Other Study ID Numbers: 7012-05-3/1
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: September 23, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified patient and results dataset will be made available upon publication of study findings
Keywords provided by Foundation for Innovative New Diagnostics, Switzerland:
Additional relevant MeSH terms:
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Tuberculosis, Pulmonary
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections