CTRI/2025/03/081585尚未招募不适用
Comparison of the Yield of CBNAAT (Cartridge Based Nucleic Acid Amplification Test) Positivity in Sputum Induced with Nebulized Hypertonic Saline versus Gastric Lavage Samples in Children with Clinically Suspected Pulmonary Tuberculosis: A Diagnostic Accuracy Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- sensitivity, specificity, positive predictive value (PPV) Of CBNAAT Of induced sputum and GA respectively compared to the gold standard (MGIT)
研究概览
简要总结
It is a diagnostic accuracy study assessing the comparison of the yield of CBNAAT (Cartridge Based Nucleic Acid Amplification Test)positivity in sputum induced with nebulized hypertonic saline vs gastric lavagesamples in children with clinically suspected pulmonary tuberculosis. The ethical clearance for this study is done and approved and henceforth the document is attached for reference. Through this platform we are registering study for CTRI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 4.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Children with presumptive pulmonary tuberculosis or disseminated tuberculosis, defined as a child with any of the symptoms or signs suggestive of TB i.e.(NTEP guidelines 2023), Fever >2 weeks ,Significant weight loss (loss of >5% of highest weight recorded in the past 3 months) or not gaining weight, Cough>2weeks, Abnormalities of chest radiograph (parenchymal infiltrate, atelectasis, pleural effusion, or lymphadenopathy) ln contact of a TB case.
- •Children with suspected immunodeficiency where PTB has to be ruled out , Children with chronic lung diseases (cystic fibrosis, bronchiectasis) where PTB should be ruled out.
排除标准
- •Children with a history of prior bronchospasm attributed to inhaled therapies, Children with a history of recent haemoptysis or pneumothorax ,Children with respiratory failure ,Patient with uncontrolled asthma or signs of upper airway obstruction.
- •Unconscious children (GCS <8) or children with convulsions, Patients in whom consent could not be obtained, Children only with extrapulmonary TB.
结局指标
主要结局
sensitivity, specificity, positive predictive value (PPV) Of CBNAAT Of induced sputum and GA respectively compared to the gold standard (MGIT)
时间窗: Only one time only at the time of diagnostic testing.
次要结局
- correlation between two methods of CBNAAT testing (sputum induction vs gastric aspirate/ lavage)(b.To assess the feasibility of inducing an adequate amount of sputum)
研究者
研究点 (1)
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