Cefixime Versus Benzathine Penicillin G in Treatment of Early Syphilis - a Randomized, Multicentre, Non-inferiority, Open Label Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Serological cure
研究概览
简要总结
This study evaluates the efficacy (non-inferiority) and safety of a new antibiotic treatment (cefixime), which has been previously used for single dose therapy of gonorrhoea in many years , in the treatment of early syphilis. Participants will be randomized to one of two study arms and will receive either expirimental regimen (cefixime) or the current standard antibiotic regimen (benzathine penicillin G). New treatment alternatives for syphilis could ensure that people are appropriately treated during periods or in settings of benzathine penicillin G stock out, penicillin allergy, or other intolerance to penicillin injection. This study may also identify an oral regimen for settings in which injections are not feasible.
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
- Single (Outcomes Assessor)
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
- •18 years of age or older
- •Non-pregnant, non breastfeeding
- •Able to provide informed consent
- •Clinically or laboratory-confirmed primary, secondary or early latent syphilis with a positive rapid treponemal test and an RPR/VDRL titer equal to or greater than 1:8
- •Non-cephalosporin allergic
- •Non-penicillin allergic
- •Agree to be occasionally called by study staff to be reminded to take study drug
- •Willing to attend follow-up visits
排除标准
- •Under 18 years of age
- •Pregnancy, breastfeeding
- •Prior history of syphilis in last two years
- •Allergy or contraindication to penicillin or cephalosporins (including allergy to cefixime)
- •Systemic antibiotic therapy in last two weeks
- •Previous enrollment in the study
- •Presenting a situation or condition that would not allow reliable study follow up (For example: frequent travel, alcohol abuse or substance misuse)
研究组 & 干预措施
Cefixime
cefixime 400 mg taken orally two times a day for 14 consecutive days
干预措施: Cefixime 400mg (Drug)
benzathine penicillin G
benzathine penicillin G 2.4 MIU single dose intramuscularly
干预措施: Benzathine penicillin 2.4 million units (Drug)
结局指标
主要结局
Serological cure
时间窗: from baseline (treatment) to 3 months after treatment
a 4-fold or more (≥2 dilution steps) decrease in rapid plasma reagin (RPR) or veneral disease reach laboratory test (VDRL) titer
次要结局
- Secondary serological cure(from baseline (treatment) to 6 and 12 months after treatment)
- Treatment safety(from baseline till the end of follow-up (12 months from baseline))
研究者
Filip Rob MD, PhD
Chair of Department
Bulovka Hospital