EUCTR2011-005078-40-Outside-EU/EEA进行中（未招募）1 期
A Phase III trial in subjects suspected to have tuberculosis, comparing the diagnostic performance of C-Tb to QuantiFERON®-TB Gold In-Tube, in combination with a double blind randomised splitbody safety assessment of C-Tb versus 2 T.U. Tuberculin PPD RT 23 SSI (PPD)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,190
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •The trial population consisted of 2 types of population: 1) Symptomatic or with relevant recent exposure: Children (28 days–4 years old) with suspected Mycobacterium tuberculosis infection, children and adults between 5–65 years old suspected to have TB disease and 2) children between 5–11 years old with no TB symptoms or known exposure to Mycobacterium tuberculosis recruited from an area with a ‘low’ prevalence of TB.
- •Age groups:
- •Paediatric: 28 days–23 months, 2–4, 5–11, 12–17 years
- •Adults: 18–39 and 40–65 years
- •Major inclusion criteria:
- •HIV-negative participants with suspicion of TB disease
- •HIV-positive participants with CD4 count performed and with suspicion of TB disease
- •HIV-negative children (5–11 years) with no symptoms of TB and no known contact with the Mycobacterium tuberculosis-infected case. This group was used as a negative (healthy) control.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 602
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 587
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •Major exclusion criteria (irrespective of HIV status):
- •Had confirmed diagnosis of TB at screening visit
- •Had been vaccinated within 6 weeks before day of inclusion
- •Had been tuberculin tested <12 months before day of inclusion
- •Was pregnant, breastfeeding or intended to get pregnant during the trial
研究者
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