The DECIDE-TB Trial; Validation of Treatment Decision Algorithms for Childhood Tuberculosis
Launched by CHISHALA CHABALA · Sep 9, 2024
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
The DECIDE-TB Trial is a research study focused on improving how tuberculosis (TB) is diagnosed and treated in children, especially in countries where TB is common and healthcare resources are limited. The goal is to test a new method called Treatment Decision Algorithms (TDA), which helps healthcare providers make better decisions about screening, diagnosing, and treating TB in children under 16 years old. This trial will take place in five districts of each participating country, involving both district hospitals and primary health centers. By using TDAs, the researchers aim to create a system that makes it easier for doctors to identify and treat TB faster, ultimately leading to better health outcomes for children.
Eligible participants include children showing symptoms of TB, such as a cough lasting more than two weeks or a high fever for the same duration. The trial is looking for children from various backgrounds, including those at higher risk or those who have been in contact with someone with TB. Participants can expect to receive thorough TB screening and, if necessary, access to diagnostic tests and treatments. This study is crucial in helping healthcare systems become more effective in tackling childhood TB, ensuring that children receive timely and appropriate care.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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 Criteria:
- • Non presumptive TB cases
- • Adult patients
- • Patients not in the selected district or facilities
About Chishala Chabala
Chishala Chabala is a dedicated clinical trial sponsor committed to advancing medical research and improving patient outcomes through rigorous and ethical study designs. With a focus on innovative therapies, Chabala leads and oversees clinical trials that adhere to the highest standards of scientific integrity and regulatory compliance. By fostering collaboration among researchers, healthcare professionals, and regulatory bodies, Chishala Chabala aims to accelerate the development of groundbreaking treatments while ensuring the safety and well-being of study participants.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chingola, Copperbelt, Zambia
Chingola, Copperbelt, Zambia
Chingola, Copperbelt, Zambia
Chingola, Copperbelt, Zambia
Chingola, Copperbelt, Zambia
Chingola, Copperbelt, Zambia
Chingola, Copperbelt, Zambia
Luanshya, Copperbelt, Zambia
Luanshya, Copperbelt, Zambia
Luanshya, Copperbelt, Zambia
Luanshya, Copperbelt, Zambia
Luanshya, Copperbelt, Zambia
Luanshya, Copperbelt, Zambia
Luanshya, Copperbelt, Zambia
Luanshya, Copperbelt, Zambia
Chirundu, Southern, Zambia
Chirundu, Southern, Zambia
Chirundu, Southern, Zambia
Chirundu, Southern, Zambia
Chirundu, Southern, Zambia
Chirundu, Southern, Zambia
Chirundu, Southern, Zambia
Kalomo, Southern, Zambia
Kalomo, Southern, Zambia
Kalomo, Southern, Zambia
Kalomo, Southern, Zambia
Kalomo, Southern, Zambia
Kalomo, Southern, Zambia
Kalomo, Southern, Zambia
Patients applied
Trial Officials
Olivier Marcy
Principal Investigator
University of Bordeaux
Chishala Chabala
Principal Investigator
University of Zambia
Joanna Orne-Gliemann
Principal Investigator
University of Bordeaux
James Seddon
Principal Investigator
Imperial College London
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported