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

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
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.

Study Design

• 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

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 Name: Automated microscopy

Outcome Measures

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Peru

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

Lima, Peru

Vietnam

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

More Information

Additional Information:

TBDx Proof of concept 

TBDx performance South Africa 

• Responsible Party: Foundation for Innovative New Diagnostics, Switzerland
• ClinicalTrials.gov Identifier: NCT02912832
• Other Study ID Numbers: 7012-05-3/1
• First Posted: September 23, 2016
• 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:

Diagnosis

Additional relevant MeSH terms:

Tuberculosis; Tuberculosis, Pulmonary; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Lung Diseases; Respiratory Tract Diseases; Respiratory Tract Infections