Tuberculosis
Conditions
Interventions
Investigational diagnostic tests for TB
Sponsors
CHPR
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Aged =15 years People with presumptive TB, including: an abnormal chest X-ray OR cough >2 weeks OR any of W4SS (cough, fever, night sweats, weight loss) OR TB risk factor(s) including history of TB treatment, living with HIV, at risk of undernutrition, at risk of alcohol use disorders or use of tobacco Willing to provide the specimens needed for testing For those aged 15-20 years: a parent or guardian present at the time of enrolment to provide signed informed consent
Exclusion criteria
Exclusion criteria: Unwilling to provide informed consent (people aged 20 years and above) or unwilling to provide informed assent (15-20 years of age) Are currently on anti-TB treatment or who have taken anti-TB treatment within 60 days of enrollment Have taken tuberculosis preventive treatment (TPT) within 6 months of enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Point estimates, with 95% confidence interval, of the sensitivity and specificity of the new assays as compared to the defined reference standards | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference between point estimates, with 95% confidence interval, of the sensitivity and specificity of the new molecular assays relative to sputum Ultra as comparator, using the microbiological reference standard ;Operational and implementation characteristics of assays;Perspectives and preferences of stakeholders;Cost-effectiveness using incremental cost-effectiveness ratio in natural units of cost per additional case detected | — |
Countries
Cameroon
Contacts
Public ContactCyrille Mbuli
CHPR
Outcome results
None listed