Validation of Treatment Decision Algorithms for Childhood Tuberculosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The DECIDE-TB project aims to implement and evaluate a comprehensive Treatment Decision Algorithms (TDA) approach for screening, diagnosing, and treating tuberculosis in children under 15 years in Zambia and Mozambique. This pragmatic cluster-randomized trial will assess the effectiveness, feasibility, and acceptability of the TDA-based approach at district hospitals and primary health centers. The study will involve symptomatic children entering selected health facilities, focusing on improving TB case detection and treatment decision-making in resource-limited settings.

Why it matters

Who can join: the full rules

Inclusion Criteria:

The effectiveness assessment will be conducted using aggregated or individual data from direct beneficiaries of the intervention:

* All sick children aged below 15 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 through community- or facility-based household contact tracing.
* Children with presumptive TB.

The WHO definition of presumptive TB will be used, as defined in the 2022 WHO Operational Handbook, namely: children are classified as having presumptive TB if they have unremitting symptoms lasting more than 2 weeks (any one of cough, fever, not eating well or anorexia, weight loss or failure to thrive, fatigue, reduced playfulness or decreased activity) .

The definitions of presumptive TB have been adapted locally for the programmatic pilot. All children with presumptive TB as defined locally will be considered in the intervention and in secondary effectiveness and sub-group analyses.

High-risk group will be defined using the definition in WHO-suggested TDAs A\&B as children younger than 2 years, CLHIV or children with SAM. CLHIV will be defined per national testing strategy including positive PCR test for children below the age of 18 months. Children will be considered to have SAM (and thereby be eligible for the TB-Speed SAM algorithm) using WHO criteria. These include being \<5 years with a weight-for-height Z score (WHZ) \< -3 SDs or mid-upper arm circumference (MUAC) \< 115 mm (in children over 6 months) or clinical signs of bilateral pitting oedema, and being aged ≥5 years with a body mass index (BMI) for age Z-score \< -3SD.

Exclusion Criteria:

There will be no exclusion criteria for the programmatic pilot: all children will be offered the intervention.

Where it's running

• Chawama Urban Health Centre
  Chingola, Copperbelt, Zambia Recruiting
• Chiwempala Urban Health Centre
  Chingola, Copperbelt, Zambia Recruiting
• Kabundi East Urban Health Clinic
  Chingola, Copperbelt, Zambia Recruiting
• Kasompe Urban Health Centre
  Chingola, Copperbelt, Zambia Recruiting
• Muchinshi Rural Health Centre
  Chingola, Copperbelt, Zambia Recruiting
• Nchanga 1 Urban Health Centre
  Chingola, Copperbelt, Zambia Recruiting

Study contacts

• Principal investigator: Olivier Marcy — University of Bordeaux
• Study coordinator: Clementine Roucher
• Email: clementine.roucher@u-bordeaux.fr
• Phone: +330557574723

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.