Start Taking Action for Tuberculosis in Kids
ConditionTB - Tuberculosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-15
SponsorLiverpool School of Tropical Medicine
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Xpert MTB/RIF Ultra
Diagnostic testautomated molecular test
Truenat, MTB
Diagnostic testMicro-Polymerase Chain Reaction (PCR) diagnostic test
Truenat MTB Plus
Diagnostic testMicro-Polymerase Chain Reaction (PCR) diagnostic test
TB LAMP
Diagnostic testmanual molecular test
Treatment groups
7,920 Participants
are divided into 1 treatment groupGroup A: DiagnosticOther 4 interventions
Trial outcomes
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)).
Time frame
1 YearLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Liverpool School of Tropical Medicine
Lead sponsor
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
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: