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Study on the Use of Tongue Swab Samples to Detect TB in Children Using a Molecular Test

Utility of Tongue Swab in Diagnosis of Pulmonary Tuberculosis In Children Using Nucleic Acid Amplification test. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/08/092746
Enrollment
100
Registered
2025-08-11
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Health Condition 1: A159- Respiratory tuberculosis unspecified

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil Control Intervention1: Nil: Nil

Sponsors

Department of Paediatrics Maulana Azad Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Persistent fever without a known cause and Unremitting cough more than 2 weeks Weight loss of 5 percentage or no weight gain in the past 3 months despite adequate nutrition or failure of nutritional rehabilitation in baby with SAM With or without contact with patient with pulmonary TB in past 2 years

Exclusion criteria

Exclusion criteria: Children who received Antitubercular Therapy For more than 72 hours . Children who can expectorate.

Design outcomes

Primary

MeasureTime frame
Proportion of cases who are found to be positive on Tongue swab testing using Rapid cell Lysis System True lyse tm and NAAT True NAT MTB ultima among presumptive cases of pulmonary TB.Timepoint: within 24 hours of sample processing

Secondary

MeasureTime frame
Sensitivity & specificity of GA CBNAAT & GA Truenat Using MGIT as gold standard . To compare sensitivity & specificity of Tonque swab NAAT against GA NAAT Timepoint: within 24 hours of sample processing

Countries

India

Contacts

Public ContactAshish Kumar Yadav

Department of Paediatrics Maulana Azad Medical College and Associated Lok Nayak Hospital

doctoranuragagarwal@gmail.com9810409625

Outcome results

None listed

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