PACTR202006814433059招募中未知
Evaluation of four stool processing methods combined with Xpert MTB/RIF Ultra for diagnosis of intrathoracic Paediatric TB
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- INSERM
- 入组人数
- 274
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 Day(s) 至 1 Month(s)（—）
- 性别
- All
入选标准
- •For the prospective cohort:
- •Children < 15 years old
- •Presumptive intra-thoracic TB based on at least one criterion among the following:
- •- Persistent cough for more than 2 weeks
- •- Persistent fever for more than 2 weeks
- •- Recent failure to thrive (documented clear deviation from a previous growth trajectory in the last 3 months or Z score weight/age < 2)
- •- Failure of broad-spectrum antibiotics for treatment of pneumonia
- •- Suggestive CXR features
- •- OR History of contact with a TB case and any of the symptoms listed under point 2 with shorter duration (< 2 weeks) if the child is HIV infected or presents with SAM.
- •Signed informed consent by parent or guardian and assent signed by children > 7 years old
- •For the enrichment cohort:
- •Children < 15 years old
- •Presumptive intra-thoracic TB based on at least one criterion among the following:
- •- Persistent cough for more than 2 weeks
- •- Persistent fever for more than 2 weeks
- •- Recent failure to thrive (documented clear deviation from a previous growth trajectory in the last 3 months or Z score weight/age < 2)
- •- Failure of broad-spectrum antibiotics for treatment of pneumonia
- •- Suggestive CXR features
- •- OR History of contact with a TB case and any of the symptoms listed under point 2 with shorter duration (< 2 weeks) if the child is HIV infected or presents with SAM
- •One positive Xpert (MTB/Rif or Ultra) result from at least one respiratory sample: sputum or GA
- •Signed informed consent by parent or guardian and assent signed by children > 7 years old
排除标准
- •> 5 days of antituberculosis treatment in the last 3 months
- •History of tuberculosis preventive therapy in the last 3 months
- •Confirmed extrapulmonary TB only
研究者
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