NCT07798232尚未招募3 期
Penicillin to Prevent Early Rheumatic Heart Disease in School-Aged Children
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 9,622
- 试验地点
- 1
- 主要终点
- Cumulative Incidence of Rheumatic Heart Disease
研究概览
简要总结
This study will look at whether children ages 5-8 who take Penicillin V by mouth twice a day are less likely to develop rheumatic heart disease (RHD) over a 3-year period compared to children who do not take the medicine.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 5-8 years at enrollment
- •Residence within the participating study catchment area (Gulu District or Gulu City)
- •Normal study echocardiogram confirmed by the expert adjudication panel
- •Parent/guardian able and willing to provide written informed consent
- •Participant able to provide written assent (age 8 years)
排除标准
- •History of prior ARF or RHD with or without cardiac involvement
- •Evidence of RHD on baseline echocardiography
- •Congenital heart disease (excluding small PFO, small ASD) or other cardiac abnormality at baseline echocardiography
- •Self-reported known allergy to penicillin
- •Medical conditions that would preclude safe participation, adherence, or follow-up
- •Anticipated inability to complete 36 months of study follow-up
- •Any known co-morbid condition requiring regular antibiotic prophylaxis
研究组 & 干预措施
No Prophylaxis
No Intervention
Oral Penicillin V
Active Comparator
干预措施: Oral Penicillin V (Drug)
结局指标
主要结局
Cumulative Incidence of Rheumatic Heart Disease
时间窗: 3 years
Proportion of participants with newly diagnosed RHD based on blinded echocardiographic adjudication among children with a normal baseline echocardiogram.
次要结局
- Cumulative Incidence of RHD at One Year(1 year)
- Number of Participants who Develop Acute Rheumatic Fever(3 years)
- Cumulative Incidence of RHD at Two Years(2 years)
- Number of Participants who Develop Early RHD(3 years)
- Number of Participants who Develop Advanced RHD(3 years)
- Number of Participants Experiencing Treatment-Emergent Adverse Events(3 years)
- Number of Participants Achieving at least 80% Adherence to Oral Penicillin V Prophylaxis(3 years)
- Number of Participants Achieving at least 80% Adherence to Oral Penicillin V Prophylaxis Based on Pill Count(3 years)
- Number of Participants Achieving at Least 80% Adherence to Oral Penicillin V Prophylaxis Based on DoseSmart® Bottle Opening Records(3 years)
- Number of Participants Achieving at Least 80% Adherence to Oral Penicillin V Prophylaxis Based on Caregiver-Reported Dosing Diary(3 years)
研究者
研究点 (1)
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