Omni/Ultra trial
Not Applicable
- Conditions
- Tuberculosis
- Registration Number
- PACTR201704002117402
- Lead Sponsor
- Ifakara Health Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 1600
Inclusion Criteria
Adult 18 years old and above presumptive TB patients
Ability to produce sputum
Exclusion Criteria
Presumptive TB patients with symptoms only attributable to extra-pulmonary TB
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of participants who have bacteriologically confirmed TB and have TB therapy initiated within 60 days of enrolment;Additionally notified TB cases during intervention compared to the standard of care (direct yield)
- Secondary Outcome Measures
Name Time Method Proportion of participants completing testing with microbiological tests;Proportion diagnosed with microbiologically confirmed TB;Time to treatment initiation based on microbiologically confirmed TB diagnosis;Proportion diagnosed with TB (either microbiologically or clinically);Time to TB treatment initiation based on either microbiologically or clinically diagnosed TB;Death or pre-treatment LTFU;Death or overall LTF