Status:
RECRUITING
The DECIDE-TB Trial; Validation of Treatment Decision Algorithms for Childhood Tuberculosis
Lead Sponsor:
Chishala Chabala
Collaborating Sponsors:
University of Bordeaux
Instituto Nacional de Saúde, Mozambique
Conditions:
Tuberculosis
Child Health
Eligibility:
All Genders
Up to 15 years
Phase:
NA
Brief Summary
The Decide-TB project aims to generate evidence for the implementation of a comprehensive Treatment Decision Algorithms (TDA) based approach for TB in children living in high TB burden and resource-li...
Detailed Description
The Decide-TB trial is a pragmatic cluster-randomized study utilizing a stepped wedge design to provide scientific evidence on a comprehensive TDA-based approach for TB screening, diagnosis, and treat...
Eligibility Criteria
Inclusion
- For TB screening, all symptomatic children \<16 years entering the selected health facilities (DH and PHC) at either outpatient (OPD) or inpatient (IPD) departments, including children from high-risk groups, as well as children identified as contact of TB cases.
- For access to TB diagnostic services and TDAs, children aged below 16 years identified with presumptive TB, i.e. those with ≥1 systematic screening criteria, among the following:
- Cough with a duration of \>2 weeks,
- Fever with a duration of \>2 weeks,
- Documented weight loss,
- History of TB contact with any duration of cough, OR identified by the site clinician irrespective of the above criteria, especially presumed extra-pulmonary TB cases.
Exclusion
- Non presumptive TB cases
- Adult patients
- Patients not in the selected district or facilities
Key Trial Info
Start Date :
June 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2027
Estimated Enrollment :
30240 Patients enrolled
Trial Details
Trial ID
NCT06593080
Start Date
June 1 2024
End Date
March 31 2027
Last Update
September 19 2024
Active Locations (29)
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1
Chawama Urban Health Centre
Chingola, Copperbelt, Zambia
2
Chiwempala Urban Health Centre
Chingola, Copperbelt, Zambia
3
Kabundi East Urban Health Clinic
Chingola, Copperbelt, Zambia
4
Kasompe Urban Health Centre
Chingola, Copperbelt, Zambia