Status:
COMPLETED
Predicting the Future: Incipient Tuberculosis
Lead Sponsor:
Amsterdam Institute for Global Health and Development
Collaborating Sponsors:
University of Stellenbosch
Makerere University
Conditions:
Tuberculosis
Eligibility:
All Genders
12-60 years
Brief Summary
The investigators will study, prospectively, if contacts (household or close contacts) of tuberculosis (TB) patients with high C-reactive protein (CRP), low hemoglobin (Hb) levels, and a positive Xper...
Detailed Description
Although the estimated numbers of people infected with TB in Africa are declining since the rollout of antiretroviral therapy a decade ago, TB is still the highest in the world. Early diagnosis and tr...
Eligibility Criteria
Inclusion
- Index cases
- ≥18 years old
- Willing to provide the contact information of people who meet the definition of contacts, or willing to refer those people (which make require the distribution of study pamphlets) so that may contact study staff
- Willing to comply with study requirements i.e. provision of contact details and written, informed consent prior to enrolment
- Willing to provide sputa (expectorated or induced) for culture; and
- Meeting the definition for active TB.
- Contacts (cohort)
- ≥12 years old
- Meeting contact definition
- Able and willing to return for follow-up visits, with no plans to move soon
- Willing to comply with study requirements i.e. provision of contact details and written, informed consent or assent prior to enrolment
- Willing and able to provide sputum and blood
- Agree to potentially undergo CXR at M12 (women
Exclusion
- Index cases
- No informed consent or assent
- More than six weeks has passed since the index case's first bacteriological result for TB was reported
- Patient was started on treatment based on empirical or clinical grounds (including CXR) alone
- Patient with rifampicin resistance (known from Xpert, Ultra, and/or MTBDRplus results)
- Contacts (cohort)
- No informed consent or assent
- Not diagnosed with active TB
- Unwilling or unable to provide blood
- More than six weeks has passed since reporting of the index case's first positive test result
- Has taken any form of TB treatment within the preceding two months (i.e., is currently on treatment). There are no exclusions based on any TB treatment more than two months prior.
Key Trial Info
Start Date :
April 21 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 31 2025
Estimated Enrollment :
3016 Patients enrolled
Trial Details
Trial ID
NCT04825327
Start Date
April 21 2021
End Date
January 31 2025
Last Update
February 5 2025
Active Locations (3)
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1
Centro de Invesigação em Saúde de Manhiça
Manhiça, Mozambique
2
University of Stellenbosch
Cape Town, South Africa
3
Makerere University
Kampala, Uganda