ClinConnect ClinConnect Logo
Search / Trial NCT06593080

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.

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

0 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