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A study to assess diagnostic accuracy of child friendly samples ( stool & tongue swabs) for diagnosing TB in children with TB symptoms

Enhance Tuberculosis Diagnosis and Improve Linkage to TB treatment in Indian Children - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/04/085883
Enrollment
1700
Registered
2025-04-29
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: NIL: NIL

Sponsors

Central TB Division NTEP
Lead Sponsor
SHARE INDIA
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: All children with presumptive TB up to and including 18 years of age whose parents consent to providing their childrenâ??s samples for enhanced diagnosis during the designated project activity period

Exclusion criteria

Exclusion criteria: Children who received anti tubercular therapy (ATT) including second line drugs for more than 72 hours

Design outcomes

Primary

MeasureTime frame
Proportion of stool and tongue swab CBNAAT and Truenat positive among the presumptive TB children and Proportion of stool and tongue swab Xpert Ultra and Truenat Plus positive among the presumptive TB children Timepoint: 1 year—

Secondary

MeasureTime frame
c. Sensitivity and specificity of stool and tongue swab for detection of TB among the presumptive TB children considering Mycobacterium Growth Indicator tube (MGIT) liquid culture as gold standard.Timepoint: 15 months—

Countries

India

Contacts

Public ContactSanjay Kumar Mattoo MD DTCD

Central TB Division Government of India

mattoos@rntcp.org8076766625

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026