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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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3 October 2016 |
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Main ID: |
NCT02912832 |
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Date of registration:
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09/09/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Prospective Assessment of TBDx Feasibility
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Scientific title:
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TBDx Feasibility Study: Prospective Study to Determine the Feasibility of Automated Smear Microscopy |
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Date of first enrolment:
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October 2014 |
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Target sample size:
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572 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02912832 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
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Phase:
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N/A
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Countries of recruitment
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Peru
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Vietnam
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Contacts
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Name:
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Claudia M Denkinger, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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FIND |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pulmonary Tuberculosis
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Intervention(s)
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Device: TBDx
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Primary Outcome(s)
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Performance of TBDx compared to culture
[Time Frame: 6 months]
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Secondary Outcome(s)
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Performance of TBDx in combination with Xpert MTB/RIF through analysis of two different algorithms
[Time Frame: 6 months]
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Training needs through questionnaire assessment
[Time Frame: 6 months]
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User appraisal regarding ease of use, hands-on-time and perceived benefit through appraisal questionnaire
[Time Frame: 6 months]
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Comparison of performance of TBDx on direct vs concentrated smear
[Time Frame: 6 months]
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Identify potential difficulties for implementation through observation and user appraisal
[Time Frame: 6 months]
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Secondary ID(s)
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7012-05-3/1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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