TB - TuberculosisStart4KidsNCT07248423
Start Taking Action for Tuberculosis in Kids
A study testing Xpert MTB/RIF Ultra, Truenat, MTB and Truenat MTB Plus in people with TB - Tuberculosis, run by Liverpool School of Tropical Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- TB - Tuberculosis
- What is being tested?
- Xpert MTB/RIF Ultra, Truenat, MTB and Truenat MTB Plus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,920 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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)
About this study
Official title: Evaluating the Performance, Feasibility, Acceptability and Cost Effectiveness of Concurrent Testing Including Novel Diagnostics, Non-sputum Specimens and Computer-aided Detection Interpretation of Chest X-ray for Childhood Tuberculosis in Bangladesh, Cameroon, Kenya and Viet Nam.
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.
Read the detailed description
Each year an estimated 1.25 million children and adolescents under 15 years old become sick due to tuberculosis (TB). Despite TB being preventable and curable, in 2023, approximately 191 000 children died from the disease (Global Tuberculosis Report 2024). While treatment is both effective and tolerable, case detection continues to challenge many national TB programmes (NTPs), particularly in children under 5 years old. Less than half of children and young adolescents with TB are diagnosed and notified each year. Diagnostic gaps The reasons for this large gap in case detection are multiple. In children, obtaining sputum is particularly challenging as they rarely expectorate, and invasive collection procedures such as gastric aspiration or induced sputum are often required. This limits the feasibility of routine bacteriological testing, especially within lower levels of care. When sputum can be obtained, specimen collection, particularly in younger children, requires trained and experienced staff. Bacteriological confirmation is less frequent due to the paucibacillary nature of disease in children and the resultant reduction in sensitivity when using available diagnostic tests. To address these limitations, research studies and programmes often apply the NIH clinical case definition as a reference standard, recognising the challenges of achieving microbiological confirmation in this age group. However, this approach also has limitations, as chest X-ray, a key component of the definition, has inherent limitations in diagnostic accuracy, even when interpreted under standardised conditions by multiple experts and particularly so in small children. Further, clinical syndromes are often non-specific and can be rapidly progressive, resulting in frequent misdiagnosis and associated early mortality.
To overcome some of these barriers, health systems often require referral of children with signs, symptoms, or screening investigations consistent with TB ("presumptive TB") to secondary or tertiary health centres so that expert staff can be consulted, and relevant specimens, or further specimens, taken. This may result in additional cost for both the child and their family and the health system, cause further delays in diagnosis and treatment initiation, and may ultimately result in greater morbidity and mortality.
To reduce the case detection gap and to avoid diagnostic delays, policymakers and programme implementers have promoted child and adolescent TB assessment at primary healthcare (PHC) or child health centres, often through integration into existing child services diagnosing similar conditions. While child TB case notifications prior to the COVID-19 pandemic had been increasing, they declined sharply between 2019 and 2020 due to COVID. Childhood notifications recovered more slowly compared to adults in 2021, and efforts continue to be hampered by limited PHC staff expertise, poor access to diagnostic tests including chest X-ray, and a lack of dedicated time for over-burdened health care staff.
- Conditions
- TB - Tuberculosis
- Being tested
- Xpert MTB/RIF Ultra, Truenat, MTB, Truenat MTB Plus, TB LAMP
- Keywords
- TB, Diagnostics
- Medical subject headings
- Latent Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xpert MTB/RIF UltraDiagnostic test
automated molecular test
Truenat, MTBDiagnostic test
Micro-Polymerase Chain Reaction (PCR) diagnostic test
Truenat MTB PlusDiagnostic test
Micro-Polymerase Chain Reaction (PCR) diagnostic test
TB LAMPDiagnostic test
manual molecular test
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic | Other | Diagnostic Test - all participants Receives: Diagnostic Test: Xpert MTB/RIF Ultra; Diagnostic Test: Truenat, MTB; Diagnostic Test: Truenat MTB Plus; Diagnostic Test: TB LAMP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)).
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start1 Mar 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TB - TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7,920 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liverpool School of Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Control of Chronic Disease (CCCD),icddr,b, Comité National d'Ethique pour la Recherche en Santé Humaine, KEMRI-Wellcome Trust Collaborative Research Program, National Lung Hospital, Vietnam
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07248423
- Sponsor's protocol ID
- 123
- Acronym
- Start4Kids
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised IPD will be sared with partner country researchers, WHO, UNITAID. Dataset will be available from LSTM according to their data storage and sharing conditions.
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Performance, Feasibility, Acceptability and Cost Effectiveness of Concurrent Testing Including Novel Diagnostics, Non-sputum Specimens and Computer-aided Detection Interpretation of Chest X-ray for Childhood Tuberculosis in Bangladesh, Cameroon, Kenya and Viet Nam.
- ClinicalTrials.gov ID
- NCT07248423
- Acronym / sponsor ID
- Start4Kids / 123
- Conditions
- TB - Tuberculosis
- Keywords
- TB, Diagnostics
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 7,920 participants (estimated)
- Lead sponsor
- Liverpool School of Tropical MedicineUniversity, hospital or other
- Collaborators
- Centre for Control of Chronic Disease (CCCD),icddr,b, Comité National d'Ethique pour la Recherche en Santé Humaine, KEMRI-Wellcome Trust Collaborative Research Program, National Lung Hospital, Vietnam
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Each year an estimated 1.25 million children and adolescents under 15 years old become sick due to tuberculosis (TB). Despite TB being preventable and curable, in 2023, approximately 191 000 children died from the disease (Global Tuberculosis Report 2024). While treatment is both effective and tolerable, case detection continues to challenge many national TB programmes (NTPs), particularly in children under 5 years old. Less than half of children and young adolescents with TB are diagnosed and notified each year. Diagnostic gaps The reasons for this large gap in case detection are multiple. In children, obtaining sputum is particularly challenging as they rarely expectorate, and invasive collection procedures such as gastric aspiration or induced sputum are often required. This limits the feasibility of routine bacteriological testing, especially within lower levels of care. When sputum can be obtained, specimen collection, particularly in younger children, requires trained and experienced staff. Bacteriological confirmation is less frequent due to the paucibacillary nature of disease in children and the resultant reduction in sensitivity when using available diagnostic tests. To address these limitations, research studies and programmes often apply the NIH clinical case definition as a reference standard, recognising the challenges of achieving microbiological confirmation in this age group. However, this approach also has limitations, as chest X-ray, a key component of the definition, has inherent limitations in diagnostic accuracy, even when interpreted under standardised conditions by multiple experts and particularly so in small children. Further, clinical syndromes are often non-specific and can be rapidly progressive, resulting in frequent misdiagnosis and associated early mortality.
To overcome some of these barriers, health systems often require referral of children with signs, symptoms, or screening investigations consistent with TB ("presumptive TB") to secondary or tertiary health centres so that expert staff can be consulted, and relevant specimens, or further specimens, taken. This may result in additional cost for both the child and their family and the health system, cause further delays in diagnosis and treatment initiation, and may ultimately result in greater morbidity and mortality.
To reduce the case detection gap and to avoid diagnostic delays, policymakers and programme implementers have promoted child and adolescent TB assessment at primary healthcare (PHC) or child health centres, often through integration into existing child services diagnosing similar conditions. While child TB case notifications prior to the COVID-19 pandemic had been increasing, they declined sharply between 2019 and 2020 due to COVID. Childhood notifications recovered more slowly compared to adults in 2021, and efforts continue to be hampered by limited PHC staff expertise, poor access to diagnostic tests including chest X-ray, and a lack of dedicated time for over-burdened health care staff.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic | Other | Diagnostic Test: Xpert MTB/RIF Ultra, Diagnostic Test: Truenat, MTB, Diagnostic Test: Truenat MTB Plus, Diagnostic Test: TB LAMPDiagnostic Test - all participants |
Who may qualify
- Ages
- 0 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xpert MTB/RIF Ultraautomated molecular test | Diagnostic test | Diagnostic |
| Truenat, MTBMicro-Polymerase Chain Reaction (PCR) diagnostic test | Diagnostic test | Diagnostic |
| Truenat MTB PlusMicro-Polymerase Chain Reaction (PCR) diagnostic test | Diagnostic test | Diagnostic |
| TB LAMPmanual molecular test | Diagnostic test | Diagnostic |
Primary outcome
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.
Time frame: 1 Year
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)).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: Yes. Anonymised IPD will be sared with partner country researchers, WHO, UNITAID. Dataset will be available from LSTM according to their data storage and sharing conditions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Xpert MTB/RIF Ultra, Truenat, MTB and Truenat MTB Plus in people with TB - Tuberculosis, run by Liverpool School of Tropical Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.