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To study the effect of pooling of gastric aspirate contents(3 samples mixed together) for increased yield in diagnosis of Tuberculosis in children through NAAT(diagnostic test).

Utility of pooling of Gastric Aspirate for Nucleic Acid Amplification Test in Diagnosis of suspected cases of Pulmonary Tuberculosis in children - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/09/073821
Enrollment
75
Registered
2024-09-12
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

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 Health Condition 2: A150- Tuberculosis of lung

Interventions

Intervention1: nil: nil Control Intervention1: nil: nil

Sponsors

Department of Pediatrics
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Suspected cases of pulmonary Tuberculosis according to National Tuberculosis Elimination Program guidelines(2022).

Exclusion criteria

Exclusion criteria: Children who received Antitubercular Therapy for more than 7 days. Children who can expectorate.

Design outcomes

Primary

MeasureTime frame
Nucleic acid amplification test (NAAT) positives as a proportion of suspected/culture confirmed cases of pulmonary tuberculosis on 3-Day Pooled Gastric aspirate (GA).Timepoint: Day 1 and Day 3—

Secondary

MeasureTime frame
1. Sensitivity, specificity, Positive Predictive Value & Negative Predictive Value of NAAT on 3-Day pooled Gastric aspirate as compared to MGIT. 2. Sensitivity, specificity, Positive Predictive Value & Negative Predictive Value of NAAT on a single (Day-1) Gastric aspirate as compared to MGIT. Timepoint: Day 1 & Day 3—

Countries

India

Contacts

Public ContactOmkar Doiphode

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