A comparative study of Injection Benzathine Penicillin and Injection Ceftriaxone in the management of Early Syphilis
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Serological response as defined as a four fold decrease in the initial RPR titre within 6 months of treatment
研究概览
简要总结
This study is a randomized controlled trial which aims at comparing the efficacy Injection Benzathine Penicillin and Injection Ceftriaxone in the management of Early syphilis. Several studies have shown the efficacy of Injection Ceftriaxone in the management of Neurosyphilis and Primary and secondary syphilis in special populations like those infected with HIV and pregnant women. But there are limited studies available supporting Injection ceftriaxone as an alternative treatment for Early syphilis without HIV infection. The outcome will be measured by the fourfold decline in RPR titre from the baseline. Patients who have treatment failure with Injection Ceftriaxone will be given the standard dose of Injection Benzathine Penicillin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 12.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients who present in STD Clinics with untreated Early syphilis (Includes Primary, Secondary and Early latent syphilis).
- •Operational definition for Early syphilis – 1 year from the primary lesion(chancre) or if there is no primary chancre 1 year from the date of last contact with REACTIVE RPR & Confirmed by POSITIVE TPHA.
排除标准
- •Positive skin-test reaction to penicillin antigen and ceftriaxone antigen
- •History of penicillin and ceftriaxone allergy
- •Patients who have received any other antibiotics before initiation of treatment
- •Patients with Late latent syphilis and Tertiary syphilis.
结局指标
主要结局
Serological response as defined as a four fold decrease in the initial RPR titre within 6 months of treatment
时间窗: Serological response as defined as a four fold decrease in the initial RPR titre within 6 months of treatment
次要结局
- Comparing the time taken for RPR to fall in both groups and to monitor for Adverse events if any in both groups(6 months)
研究者
Dr Briswin Jino B G
Government Tirunelveli Medical College