Status:
UNKNOWN
Early Risk Assessment in Household Contacts (≥10 Years) of TB Patients by New Diagnostic Tests in 3 African Countries
Lead Sponsor:
Michael Hoelscher
Collaborating Sponsors:
European and Developing Countries Clinical Trials Partnership (EDCTP)
Conditions:
Tuberculosis
Eligibility:
All Genders
10+ years
Brief Summary
The ERASE - TB study will be conducted in order to fill a critical unmet need for tuberculosis control. Persons who are in contact with an infectious TB case may become infected themselves. Among thos...
Eligibility Criteria
Inclusion
- TB index case:
- Aged at least 18 years
- Having at least one other person living in the household aged ≥10 years
- Written informed consent to conduct socio-economic and clinical questionnaire, to provide a sputum sample for culture and sequencing, and to approach the household members.
- Recently diagnosed with active pulmonary TB within the last 4 weeks
- Has taken less than 7 daily doses of anti-TB treatment since diagnosis; ensuring a positive culture can still be obtained
- Able to spontaneously produce sputum
- Sputum microscopy positive in Ziehl-Neelsen or Auramine-O staining of ideally 2+ or higher, but at least 1+ on the IUATLD/WHO scale, OR (in case no sputum microscopy done) GeneXpert positive, at least TB "medium"
- A firm home address, maintained unchanged for the last 6 months, that is accessible to visiting
- Household Contact:
- Aged at least 10 years
- Written informed consent for study participation, including HIV testing, and home visits by the study team for follow-up (for minors \<18 yr.: consent of the parent/guardian, assent of the participant)
- Recent (in the last 4 weeks), substantial exposure to an infectious TB case in the household, defined as sleeping at least 3/7 nights in the same household
- If HIV negative: not on preventive therapy (preventive therapy is not an exclusion criterion for HIV positive persons)
Exclusion
- Household Contact
- Circumstances that raise doubt on free, uncoerced informed consent (e.g. in a mentally handicapped person)
- Prisoners
- Recent treatment for active TB, completed within the last 30 days OR on current TB treatment for active TB.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 30 2024
Estimated Enrollment :
2100 Patients enrolled
Trial Details
Trial ID
NCT04781257
Start Date
March 1 2021
End Date
April 30 2024
Last Update
November 28 2023
Active Locations (3)
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1
Instituto Nacional de Saúde (INS) Centro de Investigação e Treino em Saúde da Polana Caniço
Maputo, Mozambique
2
NIMR - Mbeya Medical Research Centre
Mbeya, Tanzania
3
Biomedical Research & Training Institute (BRTI)
Harare, Zimbabwe