Preventing Mycobacterium Tuberculosis Infection in HIV-Exposed Infants
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Mycobacterium Tuberculosis (MTB) Infection
研究概览
简要总结
Randomized controlled trial (RCT) of isoniazid (INH) vs. no INH to prevent Mycobacterium tuberculosis infection in HIV-exposed uninfected (HEU) infants.
详细描述
The purpose of this trial is to determine whether isoniazid (INH) reduces the risk of Mycobacterium tuberculosis (MTB) infection in HIV-exposed but uninfected (HEU) children, as well as to determine epidemiologic and immunologic correlates of MTB infection in HEU.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Weeks 至 10 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •HIV exposed infants
- •Aged 6 weeks within (+ 4 weeks)
- •Born to HIV-infected mothers
- •Not premature and over 2.5 kg
排除标准
- •Infants with known exposure to active TB in household
- •Premature and < 2.5 kg
研究组 & 干预措施
Isoniazid
Isoniazid (INH) ~10 mg/kg (7-15 mg/kg), will be administered once daily to infants in INH arm for 12 months.
干预措施: Isoniazid (Drug)
结局指标
主要结局
Mycobacterium Tuberculosis (MTB) Infection
时间窗: at 12 months post randomization
Among HEU infants enrolled at approximately 6 weeks of age, compare the risk of acquiring MTB infection during 1 year of follow-up in infants randomized to receive INH vs. no INH using an interferon-gamma release (IGRA) QuantiFERON-TB Gold Plus (QFT-Plus) assay or tuberculin skin test as part of a composite endpoint to determine MTB infection status
Mycobacterium Tuberculosis (MTB) Infection Cumulative Incidence
时间窗: at 12 months post randomization
Among HEU infants enrolled at approximately 6 weeks of age, compare the risk of acquiring MTB infection during 1 year of follow-up in infants randomized to receive INH vs. no INH using an interferon-gamma release (IGRA) QuantiFERON-TB Gold Plus (QFT-Plus) assay or tuberculin skin test as part of a composite endpoint to determine MTB infection status
次要结局
- Severe Adverse Events (SAE)(Over 12 months after randomization)
- Combined Outcome of MTB Infection, TB Disease, and Death(Over 12 months after randomization)
- Combined Outcome of MTB Infection Including IGRA, TST, and Additional Interferon-gamma-independent Immune Markers in QFT-Plus Supernatants(Over 12 months after randomization)
研究者
Grace John-Stewart
Professor, Global Health, Medicine, Epidemiology, Pediatrics
University of Washington