NCT02857959Unknown4 期
Doctor of Medicine
Jun Li1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2016年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Rapid plasma reagin titers
研究概览
简要总结
The purpose of this study is to observe the serological response to 1 or 3 weekly doses of benzathine penicillin G in patients with early syphilis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persons with confirmed early symptomatic syphilis (primary or secondary) or high-titer latent syphilis
- •A rapid plasma reagin (RPR) test was positive, with a titer were 1:4 or higher. In addition, Treponema pallidum particle agglutination assay and/or fluorescent treponemal antibody absorption test were reactive.
排除标准
- •1.Patients who were pregnancy, known allergy to penicillin, use of antibiotics active against syphilis during the preceding six months for symptomatic cases or during the preceding two years for asymptomatic cases, and concurrent illnesses requiring treatment with antibiotics effective against syphilis.
- •if RPR titers were found to be 1:4 or less or the T. pallidum particle agglutination test was nonreactive, participants were retrospectively excluded from the trial unless primary syphilis was confirmed by the finding of T. pallidum in ulcer exudates on direct immunofluorescence
研究组 & 干预措施
single dose benzathine penicillin G.
Experimental
single dose benzathine penicillin G.
干预措施: Benzathine Penicillin G (Drug)
three doses of benzathine penicillin G.
Active Comparator
three doses of benzathine penicillin G.
干预措施: Benzathine Penicillin G (Drug)
结局指标
主要结局
Rapid plasma reagin titers
时间窗: up to 9 months after treatment
次要结局
未报告次要终点
研究者
Jun Li
M.D.
Peking Union Medical College Hospital
研究点 (1)
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