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临床试验/NCT02884115
NCT02884115Unknown4 期

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

Peking Union Medical College Hospital1 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
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

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

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jun Li

M.D.

Peking Union Medical College Hospital

研究点 (1)

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