jRCT1031210615招募中不适用
Efficacy of amoxicillin therapy versus benzathine penicillin G for early syphilis, a multicenter, open-Label, randomized, controlled clinical trial
未提供0 个研究点目标入组 208 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 208
- 主要终点
- Serological cure rate at 6 months after treatment
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Patients aged 20 years or older.
- •Patients provided an informed consent in writing.
- •Patients diagnosed with early syphilis based on the following criteria (i) positive RPR conversion or (ii) four-fold increase in RPR titer compared to previous RPR titer
- •Patients has a positive non-treponemal assay result.
排除标准
- •Individuals with pregnancy
- •Individuals with a history of known hypersensitivity to BPG, amoxicillin or probenecid.
- •Individuals with neurosyphilis including ocular syphilis and otosyphilis.
- •Individuals with late syphilis.
- •Patients required antibiotics that effective for syphilis within the preceding three weeks
- •Person who are judged by their physicians in charge to be ineligible for any reason
结局指标
主要结局
Serological cure rate at 6 months after treatment
时间窗: 6 months after treatment
a four-fold decrease in titer in the non-treponemal assay (RPR) at month 6 or a subsequent negative result in the non-treponemal test
次要结局
- Serological cure rate(3, 9, and 12 months after treatment)
- Jarisch-Herxheimer reactions(within 2 days of treatment)
- Allergic reactions(after 4 days)
- Serological cure rate summerized by HIV status(6 months and 12 months)
- Composite endpoint
研究者
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