Randomized, Clinical Trial to Compare the Serological Response Rates of Serofast Early Syphilis Cases Retreated With Three Doses Benzathine Penicillin and Absence of Any Retreatment
试验速览
- 阶段
- 4 期
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Rapid plasma regain titer
研究概览
简要总结
A continuing challenge to determining the response to treatment of early syphilis (primary, secondary, early latent syphilis) is exemplified by the substantial proportion of patients who fail to achieve serological cure and remain serofast. Although retreatment is often done in clinical practice, optimal management remains uncertain due to the paucity of data regarding serological response to retreatment and long-term outcomes. Furthermore, the investigators cannot rule out that the gradually increasing seroreversion/serological cure rates may have been due to the natural decline in rapid plasma regain (RPR) titers after initial therapy, rather than due to the additional dose of benzathine penicillin. Thus, the investigators would like to conduct a clinical trial to compare the serological response rates of serofast early syphilis cases retreated with three doses benzathine penicillin and absence of any retreatment (control group).
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
- •Early Syphilis Cases Determined to Be Serofast at 6 Months after Initial Treatment
排除标准
- •Human immunodeficiency virus (HIV)-infected
- •Baseline serology showed a nonreactive RPR test
- •follow-up is inadequate
- •Allergic to penicillin
- •Pregnant woman
研究组 & 干预措施
Retreatment group
Serofast early syphilis cases retreated with three doses benzathine penicillin
干预措施: benzathine penicillin (Drug)
结局指标
主要结局
Rapid plasma regain titer
时间窗: 6 months after retreatment
次要结局
未报告次要终点
研究者
Jun Li
M.D.
Peking Union Medical College Hospital
