The DECIDE-TB Trial; Validation of Treatment Decision Algorithms for Childhood Tuberculosis

NARecruitingINTERVENTIONAL
Enrollment

30,240

Participants

Timeline

Start Date

June 1, 2024

Primary Completion Date

July 31, 2026

Study Completion Date

March 31, 2027

Conditions
TuberculosisChild HealthHIVSevere Acute Malnutrition
Interventions
OTHER

The comprehensive TDA based approach

"The 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."

Trial Locations (29)

Unknown

RECRUITING

Chawama Urban Health Centre, Chingola

RECRUITING

Chiwempala Urban Health Centre, Chingola

RECRUITING

Kabundi East Urban Health Clinic, Chingola

RECRUITING

Kasompe Urban Health Centre, Chingola

RECRUITING

Muchinshi Rural Health Centre, Chingola

RECRUITING

Nchanga 1 Urban Health Centre, Chingola

RECRUITING

Nchanga North Referal Hospital, Chingola

RECRUITING

Allessandras Urban Health Centre, Luanshya

RECRUITING

Chaisa Urban Health Centre, Luanshya

RECRUITING

Fisenge Urban Health Centre, Luanshya

RECRUITING

Kawama Urban Health Centre, Luanshya

RECRUITING

Malaika Urban Health Centre, Luanshya

RECRUITING

Mikomfwa Urban Health Centre, Luanshya

RECRUITING

Roan Antelope General Hospital, Luanshya

RECRUITING

Thomson District Hospital, Luanshya

RECRUITING

Chipepo Rural Health Centre, Chirundu

RECRUITING

Hachipilika Rural Health Centre, Chirundu

RECRUITING

Jamba Rural Health Centre, Chirundu

RECRUITING

Kapululira Rural Health Centre, Chirundu

RECRUITING

Lusitu Rural Health Centre, Chirundu

RECRUITING

Mtendere Mission Referal hospital, Chirundu

RECRUITING

Sikoongo Rural Health Centre, Chirundu

RECRUITING

Habulile Rural Health Centre, Kalomo

RECRUITING

Kalomo District Hospital, Kalomo

RECRUITING

Kalomo Urban Health Centre, Kalomo

RECRUITING

Mawaya Urban Health Centre, Kalomo

RECRUITING

Namwianga Urban Health Centre, Kalomo

RECRUITING

Nkandanzovu Rural Health Centre, Kalomo

RECRUITING

Siachitema Rural Health Centre, Kalomo

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

University of Bordeaux

OTHER

collaborator

Instituto Nacional de Saúde, Mozambique

OTHER_GOV

collaborator

ADERA

UNKNOWN

collaborator

University of Stellenbosch

OTHER

collaborator

Imperial College London

OTHER

collaborator

Institut de Recherche pour le Développement (IRD)

UNKNOWN

collaborator

University of Sheffield

OTHER

collaborator

Ludwig-Maximilians - University of Munich

OTHER

collaborator

Ministry of Health, Zambia

OTHER_GOV

collaborator

Ministry of Health, Mozambique

OTHER_GOV

collaborator

Eduardo Mondlane University

OTHER

collaborator

European and Developing Countries Clinical Trials Partnership (EDCTP)

OTHER_GOV

lead

Chishala Chabala

OTHER