Status:
COMPLETED
Community Initiated Preventive Therapy for TB
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
UNITAID
Aurum Institute
Conditions:
Tuberculosis
Eligibility:
All Genders
Up to 14 years
Phase:
NA
Brief Summary
Background: The World Health Organization (WHO) currently recommends household contact investigation for new tuberculosis (TB) patients in low- and middle-income countries, with an emphasis on pediatr...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Index Patient in South Africa:
- Adult pulmonary TB patient being treated for pulmonary TB disease (with bacteriologic confirmation including smear, GeneXpert® MTB/RIF and/or liquid mycobacterial culture) in one of the participating clinics
- Willing to have a home visit and disclose their diagnosis to household members
- Lives in the catchment areas of a study clinic
- Age 18 years or older
- Provides informed consent
- Inclusion Criteria for Index Patient in Ethiopia:
- Adult or child being treated for pulmonary TB disease (clinical with or without microbiologic diagnosis) in one of the participating clinics
- Willing to have a home visit and disclose their diagnosis to household members
- Lives in the catchment areas of a study clinic
- Age 18 years or older
- Provides informed consent
- Inclusion Criteria for Contact in South Africa:
- Child less than 15 years old living in the household of the TB index patient
- Caregiver willing to provide informed consent
- Children 7 years and older must also provide assent
- Inclusion Criteria for Contact in Ethiopia:
- Child less than 15 years old living in the household of the TB index patient
- Caregiver willing to provide informed consent
- Children 12 years and older must also provide assent
Exclusion
- Exclusion Criteria for Index Patient in South Africa and Ethiopia:
- Extrapulmonary TB with no evidence of concurrent pulmonary TB
- Evidence of rifampin and/or isoniazid resistance on GeneXpert® MTB/RIF or drug sensitivity testing performed on M. tuberculosis isolates identified on culture
- Household has already participated in study (more than one index patient in the household) and child contacts under 15 years have already been evaluated and remain on TPT and/or TB treatment
- Exclusion Criteria for Contact in South Africa:
- Household child contact of a drug-resistant TB index patient. (Drug resistance defined either by the presence of rifampin resistance on GeneXpert® MTB/RIF OR drug sensitivity testing on isolates identified by culture).
- Exclusion Criteria for Contact in Ethiopia:
- Household child contact of a drug-resistant TB index patient. (Drug resistance defined either by the presence of rifampin resistance on GeneXpert® MTB/RIF OR drug sensitivity testing on isolates identified by culture).
- Household contact 15 years and older
Key Trial Info
Start Date :
September 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
1168 Patients enrolled
Trial Details
Trial ID
NCT04369326
Start Date
September 7 2021
End Date
June 30 2023
Last Update
August 14 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
KNCV-Ethiopia
Oromia Region, Oromiya, Ethiopia