Start Taking Action for Tuberculosis in Kids

NCT07248423 | Not Yet Recruiting DMC

• 1 other identifier: 123
• Study Type: interventional
• Target: 7,920
• Locations: 0 countries
• Sites: N/A

Brief Summary

Start4Kids: Evaluating the performance, feasibility, acceptability and cost effectiveness of computer-aided detection (CAD) of chest X-ray (CXR) and concurrent testing using novel diagnostics and non-sputum specimens for childhood tuberculosis (TB) in Bangladesh, Cameroon, Kenya and Viet Nam.

Conditions

TB - Tuberculosis

Keywords

TB; Diagnostics

Outcome Measures

Primary Outcomes (1)

• The diagnostic accuracy (sensitivity, specificity, positive and negative predictive values) will be estimated for all individual tests and modelled combinations to evaluate a concurrent testing strategy.

  Sensitivity: the number of children and young adolescents who are diagnosed as having TB divided by the number of children classified as suffering from pulmonary TB by the adapted NIH reference definition (confirmed, unconfirmed TB). Specificity: the number of children and young adolescents who are not diagnosed as having TB divided by the number of children classified as unlikely TB by the adapted NIH reference definition. Positive predictive value: the probability a participant who tests positive for TB by a given diagnostic test or concurrent testing strategy has TB disease (determined by the adapted NIH reference definition (confirmed, unconfirmed TB)). Negative predictive value: the probability a participant who tests negative for TB by a given diagnostic test or concurrent testing strategy does not have TB disease (determined by the adapted NIH reference definition (unlikely TB)).

  1 Year

Study Arms (1)

Diagnostic

OTHER

Diagnostic Test - all participants

Diagnostic Test: Xpert MTB/RIF Ultra; Diagnostic Test: Truenat, MTB; Diagnostic Test: Truenat MTB Plus; Diagnostic Test: TB LAMP

Interventions

Xpert MTB/RIF Ultra DIAGNOSTIC_TEST

automated molecular test

Diagnostic

Truenat, MTB DIAGNOSTIC_TEST

Micro-Polymerase Chain Reaction (PCR) diagnostic test

Diagnostic

Truenat MTB Plus DIAGNOSTIC_TEST

Micro-Polymerase Chain Reaction (PCR) diagnostic test

Diagnostic

TB LAMP DIAGNOSTIC_TEST

manual molecular test

Diagnostic

Eligibility Criteria

• Age: 0 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age 14 and below on the day of assessment
• Fulfils the criteria of presumptive TB according to the definition 10.1 of the protocol, or TB associated risk factors according to the definition 10.2. of the protocol
• Diagnosed with TB disease

You may not qualify if:

• On treatment for TB disease at the time of evaluation
• Parent or guardian does not allow the child to participate in the study or declines to sign the ICF.
• The child does not wish to participate in the study or declines to sign the Assent Form (where applicable)

Sponsors & Collaborators

• Liverpool School of Tropical Medicine: lead
• Centre for Control of Chronic Disease (CCCD),icddr,b: collaborator
• Comité National d'Ethique pour la Recherche en Santé Humaine: collaborator
• KEMRI-Wellcome Trust Collaborative Research Program: collaborator
• National Lung Hospital, Vietnam: collaborator

MeSH Terms

Conditions

Latent Tuberculosis

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share