Prospective Assessment of TBDx Feasibility

Pulmonary Tuberculosis Clinical Trial

Official title:

TBDx Feasibility Study: Prospective Study to Determine the Feasibility of Automated Smear Microscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02912832
• Other study ID #: 7012-05-3/1
• Status: Completed
• Phase: N/A
• First received: September 9, 2016
• Last updated: September 21, 2016
• Start date: October 2014
• Est. completion date: August 2015

Study information

• Verified date: September 2016
• Source: Foundation for Innovative New Diagnostics, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Peru: Ethics CommitteeVietnam: Ho Chi Minh City Health Service
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 572
• Est. completion date: August 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Pulmonary Tuberculosis
• Tuberculosis
• Tuberculosis, Pulmonary

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Foundation for Innovative New Diagnostics, Switzerland

Countries where clinical trial is conducted

Peru,  Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Training needs through questionnaire assessment	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.	6 months	No
Secondary	Comparison of performance of TBDx on direct vs concentrated smear		6 months	No
Secondary	Performance of TBDx in combination with Xpert MTB/RIF through analysis of two different algorithms	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	6 months	No
Secondary	User appraisal regarding ease of use, hands-on-time and perceived benefit through appraisal questionnaire		6 months	No
Secondary	Identify potential difficulties for implementation through observation and user appraisal	Potential barriers for implementation were assessed through observation and appraisal questionnaires following study completion, taking into account total time, complexity, number of steps, etc.	6 months	No

External Links

•   TBDx performance South Africa
•   TBDx Proof of concept