Prospective Assessment of TBDx Feasibility

• ClinicalTrials.gov Identifier: NCT02912832
• Recruitment Status: Completed
• First Posted: September 23, 2016
• Last Update Posted: September 23, 2016
• Sponsor: Foundation for Innovative New Diagnostics, Switzerland
• Information provided by (Responsible Party): Foundation for Innovative New Diagnostics, Switzerland

Tracking Information

• First Submitted Date: September 9, 2016
• First Posted Date: September 23, 2016
• Last Update Posted Date: September 23, 2016
• Study Start Date: October 2014
• Actual Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 21, 2016)

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: September 21, 2016)

• 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.
• Comparison of performance of TBDx on direct vs concentrated smear [ Time Frame: 6 months ]
• 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
• User appraisal regarding ease of use, hands-on-time and perceived benefit through appraisal questionnaire [ Time Frame: 6 months ]
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Prospective Assessment of TBDx Feasibility
• Official Title: TBDx Feasibility Study: Prospective Study to Determine the Feasibility of Automated Smear Microscopy
• 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.
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: Double (Investigator, Outcomes Assessor); Primary Purpose: Diagnostic
• Condition: Pulmonary Tuberculosis

Intervention

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

Study Arms

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.

Intervention: Device: TBDx

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 21, 2016): 572
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: August 2015
• Actual Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Peru, Vietnam

Administrative Information

• NCT Number: NCT02912832
• Other Study ID Numbers: 7012-05-3/1
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

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

• Responsible Party: Foundation for Innovative New Diagnostics, Switzerland
• Study Sponsor: Foundation for Innovative New Diagnostics, Switzerland
• Collaborators: Not Provided

Investigators

• Study Director: Claudia M Denkinger, MD; Find

• PRS Account: Foundation for Innovative New Diagnostics, Switzerland
• Verification Date: September 2016