The DECIDE-TB Trial; Validation of Treatment Decision Algorithms for Childhood Tuberculosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 14
SponsorChishala Chabala
About this trial
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-limited countries, at District Hospital (DH) and Primary Health Centre (PHC) levels, and to facilitate the integration of this evidence within practices and policies.
This programmatic pilot led by the National TB Programs (NTP) will test a TDA-based approach integrating TB screening, diagnosis, treatment decision-making, and disease severity assessment for shorter treatment eligibility, for use at a lower level of healthcare. This TDA-based approach will be evaluated in a hybrid effectiveness implementation study based on a pragmatic stepped wedge cluster-randomized trial. The Decide TB project will be implemented at the district level, targeting five districts in each country. Each cluster in a district will be made up of one district hospital and six primary health centers. The study will develop a Clinical Decision Support System (CDSS) to operationalize the use of TDAs, and strengthen District Health Information Systems (DHIS2) to collect individual data, which will contribute to monitoring and evaluation, clinical mentoring, and supervision by the country's NTPs.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Design model
Sequential
Treatments tested in this trial
The comprehensive TDA based approach
Other interventionThe intervention consists of implementing a comprehensive TDA-based approach for TB diagnosis and treatment decision-making, including shorter treatment for non-severe TB in children identified as TB presumptive cases through a CDSS. It will also include the management of high-risk groups. In practice, all sick children will be assessed using the WHO-suggested TDAs A with CXR (DH) and B without CXR (PHC). CLHIV and those hospitalised with SAM at DH will have further assessment and treatment decisions based on the PAANTHER and TB-Speed SAM TDAs, respectively. Clinical and microbiological assessment data will be incorporated into a CDSS to help with the clinical decision to initiate TB treatment. The CDSS will incorporate specific features and test results for high-risk group children based on the PAANTHER TDA and the TB-Speed SAM TDA and will incorporate the results of the severity assessment to guide the choice of TB treatment duration once children are diagnosed with TB.
Treatment groups
30,240 Participants
are divided into 2 treatment groupsGroup A: Standard of CareNo intervention 0 interventions
Group B: The comprehensive TDA based approachExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Effectiveness endpoints: Children initiated on TB treatment
Proportion of children started on treatment for TB among sick children attending care at participant health facilities for any health complaints
Time frame
Throughout the study, an average of 24 monthsSecondary outcomes
1
Effectiveness endpoints: Children treated for TB among those with presumptive TB
Proportion of children treated for TB among those with presumptive TB, including children with microbiologically confirmed TB.
Time frame
Throughout the study, an average of 24 months2
Effectiveness endpoints: TB treatment proportion in high-risk pediatric groups
Proportion of children from high-risk groups treated for TB (age \<2 years, CLHIV, children with SAM) i) among all children from high-risk groups attending care, ii) among children from high-risk groups with presumptive TB.
Time frame
Throughout the study, an average of 24 months3
Effectiveness endpoints: Microbiologically confirmed TB cases
Proportion of children with TB that are microbiologically confirmed (i.e. smear or Xpert or LAM positive), ratio of \<5 to 5-14 years among children with TB, ratio of pulmonary TB to extrapulmonary TB (EPTB).
Time frame
Throughout the study, an average of 24 months4
Effectiveness endpoints: Time to TDA assessment completion
Time from presumptive TB identification to final TB treatment decision and access to TB diagnostic assessment defined as the proportion of children with presumptive TB having completed assessment with the TDAs and CDSS, including in high-risk groups.
Time frame
From the start of intervention to the end of the project, an average of 21 monthsSponsors and contacts
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Chishala Chabala
Lead sponsor
University of Zambia
Sponsor institution
University of Bordeaux
Collaborator
Instituto Nacional de Saúde, Mozambique
Collaborator
ADERA
Collaborator
University of Stellenbosch
Collaborator
Imperial College London
Collaborator
Institut de Recherche pour le Développement (IRD)
Collaborator
University of Sheffield
Collaborator
Ludwig-Maximilians - University of Munich
Collaborator
Ministry of Health, Zambia
Collaborator
Ministry of Health, Mozambique
Collaborator
Eduardo Mondlane University
Collaborator
European and Developing Countries Clinical Trials Partnership (EDCTP)
Collaborator
Source ClinicalTrials.gov