Treatment Responses of Early Syphilis to Single-dose Ceftriaxone Plus Doxycycline Versus Single-dose Benzathine Penicillin G Plus Doxycycline in People Living With HIV (PLWH)
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 109
- 试验地点
- 2
- 主要终点
- Rate of Serologic Response at Month 6
研究概览
简要总结
In a prospective study investigating the prevalence of sexually transmitted infections (STIs) among at-risk people living with HIV (PLWH), the prevalence of Chlamydia trachomatis and Neisseria gonorrhoeae was 24.7% and 12.1%, respectively. Surprisingly, the study found high rates of C. trachomatis and/or N. gonorrhoeae co-infections in PLWH with recent hepatitis C virus (HCV) infection (50%), HBsAg positivity (44%), and early syphilis (36%). Considering the high rate of sexually transmitted co-infections, combination therapy of single-dose ceftriaxone plus 7-day doxycycline for early syphilis may provide convenience and benefit to treatment of N. gonorrhoeae and C. trachomatis co-infections at a single clinic encounter. In the present study, this study aim to compare the efficacy of ceftriaxone plus doxycycline versus benzathine penicillin G (BPG) plus doxycycline as the treatment for early syphilis among PLWH.
详细描述
Enrolled criteria:
- PLWH aged 20 years or more
- PLWH with early syphilis (i.e. primary, secondary, or early latent syphilis), confirmed by a positive rapid plasma reagin (RPR) titer with a reactive Treponema pallidum particle agglutination (TPPA) assay.
- PLWH has provided informed consent *A participant with repeated syphilis can be repeated enrolled after signing an informed consent if the previous episode of early syphilis was successfully treated with achieving at least a 4-fold decrease in RPR titers and 48-week follow-up is completed.
Exclusion criteria:
- PLWH with RPR titers of less than 4
- Exposure to antibiotics with activity against T. pallidum, such as penicillins, third-generation cephems, doxycycline, or macrolides, within the preceding 4 weeks
- A known or suspected infection other than syphilis requiring additional treatment with an antimicrobial active against T. pallidum
- A history of intolerance to penicillin, ceftriaxone, or doxycycline
- Pregnancy
Primary outcome:
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PLWH aged 20 years or more
- •PLWH with early syphilis (i.e. primary, secondary, or early latent syphilis), confirmed by a positive rapid plasma reagin (RPR) titer with a reactive Treponema pallidum particle agglutination (TPPA) assay.
- •PLWH has provided informed consent
排除标准
- •PLWH with RPR titers of less than 4
- •Exposure to antibiotics with activity against T. pallidum, such as penicillins, third-generation cephems, doxycycline, or macrolides, within the preceding 4 weeks
- •A known or suspected infection other than syphilis requiring additional treatment with an antimicrobial active against T. pallidum
- •A history of intolerance to penicillin, ceftriaxone, or doxycycline
- •Pregnancy
研究组 & 干预措施
single-dose ceftriaxone plus doxycycline
single-dose ceftriaxone (1g intramuscularly once) plus doxycycline (100 mg orally twice daily for 7 days)
干预措施: Doxycycline (Drug)
single-dose ceftriaxone plus doxycycline
single-dose ceftriaxone (1g intramuscularly once) plus doxycycline (100 mg orally twice daily for 7 days)
干预措施: Ceftriaxone (Drug)
single-dose BPG plus doxycycline
single-dose BPG (2.4 million unit [MU] intramuscularly once) plus doxycycline (100 mg orally twice daily for 7 days)
干预措施: Doxycycline (Drug)
single-dose BPG plus doxycycline
single-dose BPG (2.4 million unit [MU] intramuscularly once) plus doxycycline (100 mg orally twice daily for 7 days)
干预措施: benzathine penicillin G (Drug)
结局指标
主要结局
Rate of Serologic Response at Month 6
时间窗: Month 6
Serologic response is defined as either a 4-fold or greater decline in RPR titer compared to baseline or being RPR-nonreactive
次要结局
- Rate of Microbiologic Response of Syphilis at Week 4(Week 4)
- Rate of Microbiologic Response of Bacterial STIs at Week 4(Week 4)
- Rate of Serologic Response at Month 3(Month 3)
- Rate of Serologic Response at Month 12(Month 12)