Clinical Trial Comparing the Effectiveness of Cefixime Versus Penicillin G for Treatment of Early Syphilis
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Response to treatment
研究概览
简要总结
This study aims to evaluate the efficacy of cefixime compared to benzathine penicillin G in the treatment of syphilis.
详细描述
This will be a randomized, multisite, open-label, non-inferiority clinical trial to evaluate the effectiveness of cefixime (400mg orally, twice a day, for 10 days) compared to benzathine penicillin G (2.4 million units, intramuscularly) in patients with and without HIV infection. In total, 400 participants with early syphilis will be enrolled from 9 clinical sites in the U.S. and Peru. Participants will participate in follow-ups to monitor clinical outcomes and serological response (RPR titer) every 3 months for 9 months. Study findings may identify an efficacious alternative syphilis treatment to penicillin, effective for people living with HIV infection, to help address the crisis of penicillin shortages and offer options for those with penicillin allergy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed cases of primary, secondary, or early latent syphilis with RPR titer ≥1:8 within 3 weeks prior to enrollment
- •18 years of age or older
- •Able to provide informed consent
- •Individuals with HIV infection must be on treatment for HIV infection and virologically suppressed (viral load <200 copies/mL) or have a CD4 count ≥ 350 cells/mm3 according to most recent labs before study enrollment
排除标准
- •Pregnancy or a positive pregnancy test on the day of enrollment
- •Patients showing signs and symptoms of neurosyphilis
- •Serofast RPR titer, defined as persistently positive RPR titer without more than 4-fold (2-titer level) change for 12 months or greater
- •Recent (within the past 7 days) or concomitant antimicrobial therapy with activity against syphilis, namely azithromycin, doxycycline, ceftriaxone, or other beta-lactam antibiotics (e.g. amoxicillin)
- •Individuals with HIV infection who report HIV treatment interruption for more than 4 weeks since their most recent viral load or CD4 test
- •Self-reported allergy to cephalosporins or penicillin
- •Unwilling or unable to attend follow-up visits
研究组 & 干预措施
Benzathine Penicillin G
Single intramuscular injection of 2.4 million units of benzathine penicillin G
干预措施: benzathine penicillin (Drug)
Cefixime
Oral cefixime 400mg, taken twice a day for 10 days
干预措施: Cefixime 400mg (Drug)
结局指标
主要结局
Response to treatment
时间窗: 6 months
Percentage of cefixime participants with a 4-fold decrease or greater in the serum RPR titer 3 or 6 months after treatment completion
次要结局
未报告次要终点
研究者
Jeffrey D Klausner
Clinical Professor
University of Southern California