NCT01331811已完成不适用
Improving Diagnosis of Tuberculosis in HIV Infected Children in Asia (Cambodia, Vietnam) and Africa (Burkina Faso, Cameroon) ANRS 12229 PAANTHER 01 (Pediatric Asian African Network for Tuberculosis and HIV Research)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 441
- 试验地点
- 12
- 主要终点
- Tuberculosis diagnostic algorithm
研究概览
简要总结
Childhood tuberculosis (TB) accounts for 11% of the total 9 million annual TB cases and the difficulty of its diagnosis is increased in case of HIV infection in children.
The aim of this study is to improve TB diagnosis in HIV-infected children by developing a new diagnostic algorithm incorporating new tools available such as:
- interferon gamma release assays (IGRAs), as alternative to the tuberculin skin test
- alternative specimen collection methods such as string test (or Enterotest (R)), nasopharyngeal aspirates and stools samples, as alternatives to gastric aspirate
- the Xpert MTB/RIF assay
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- — 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children aged from 0 to 13 years
- •confirmed HIV infection
- •suspicion of tuberculosis
- •informed consent signed by at least one parent or guardian
- •on ARVs or not
排除标准
- •history of anti TB treatment started in the past 2 years
- •on going tuberculosis treatment
- •Suspicion of exclusive extra-thoracic tuberculosis
结局指标
主要结局
Tuberculosis diagnostic algorithm
时间窗: 3 years
Development of an effective diagnostic algorithm for pediatric tuberculosis after evaluating the following diagnostic tests and sampling methods: * Clinical examination * Chest X-rays * Abdominal ultrasound * IGRAs * Xpert MTB/RIF * Gastric aspirate * String test * Nasopharyngeal aspirate * Stools sample * Sputum samples
次要结局
- Evaluation of the QuantiFERON(R)-TB Gold In-Tube(6 months)
- Comparison of two in-vitro IGRAs(6 months)
- Percentage of TB diagnosis sampling procedures actually performed(6 months)
- Evaluation of the morbidity (IRIS, drug toxicity and other opportunistic infections) and mortality in TB-HIV co-infected children(at 6 month of TB treatment)
- Specificity and sensibility of TB diagnosis sampling procedures compared to TB diagnosis gold standard (sputum or gastric aspirate culture)(6 months)
- Evaluation of the Xpert MTB/RIF assay(6 months)
- Comparison of the Xpert MTB/RIF test to the gold standard (culture of gastric aspirates or sputum)(6 months)
- Comparison of the performance Xpert MTB/RIF assay on sampling methods other than the reference method (gastric aspirate and sputum)(6 months)
研究者
研究点 (12)
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