CTRI/2024/09/073821尚未招募不适用
Utility of pooling of Gastric Aspirate for Nucleic Acid Amplification Test in Diagnosis of suspected cases of Pulmonary Tuberculosis in children
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Nucleic acid amplification test (NAAT) positives as a proportion of suspected/culture confirmed cases of pulmonary tuberculosis on 3-Day Pooled Gastric aspirate (GA).
研究概览
简要总结
To increase the diagnostic yield of detecting pulmonary tuberculosis in pediatric population by pooling 3 morning samples of gastric aspirate for nucleic acid amplification testing as bacilli causing the disease are proven to shed in the secretions over distributed time periods.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 6.00 Month(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Suspected cases of pulmonary Tuberculosis according to National Tuberculosis Elimination Program guidelines(2022).
排除标准
- •Children who received Antitubercular Therapy for more than 7 days.
- •Children who can expectorate.
结局指标
主要结局
Nucleic acid amplification test (NAAT) positives as a proportion of suspected/culture confirmed cases of pulmonary tuberculosis on 3-Day Pooled Gastric aspirate (GA).
时间窗: Day 1 and Day 3
次要结局
- 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.)
研究者
Dr Anurag Agarwal
Maulana Azad Medical college and Associated Lok Nayak Hospital
研究点 (1)
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