Pilot Study of Linezolid for Early Syphilis Treatment
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 24
- 试验地点
- 5
- 主要终点
- Response to Treatment
研究概览
简要总结
The study aims to evaluate the efficacy of linezolid for the treatment of syphilis.
详细描述
This will be a randomized, open-label, non-comparative, pilot trial to evaluate the efficacy of linezolid 600mg orally, twice a day, for ten days, using a contemporaneous historical control group benzathine penicillin G (single dose of 2.4 million units) in participants with and without HIV infection.
In total, 24 participants will be enrolled across multiple clinical sites in the United States. Participants will participate in follow-ups to monitor clinical outcomes and serological response (RPR titer) at 1 month, 3 months, and 6 months. A 5 and 10-day phone call will ensure adherence to treatment and evaluate safety.
Study findings may identify an efficacious alternative syphilis treatment to penicillin that is effective for people living with HIV. Study findings may also help address the crisis of penicillin shortages, difficulty in administration, 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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be eligible for this study, participants must be:
- •Diagnosed cases of primary, secondary or early latent syphilis with RPR titer ≥1:8 within 3 weeks prior to enrollment
- •16 years of age or older
- •Able to provide informed consent/assent.
- •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 as of their most recent test prior to enrollment.
排除标准
- •Pregnancy or a positive pregnancy test on the day of enrollment
- •Patients showing signs and symptoms of neurosyphilis.
- •Participants who receive certain psychotropic medications, e.g., MAO inhibitors, SNRIs, SSRIs
- •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, tetracycline, doxycycline, cefixime, 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.
- •Individuals with known myelosuppressive conditions or receiving myelosuppressive medication
- •Individuals weighing 150kg (330 lbs) or more.
- •Individuals with known end renal stage disease, for example individuals in hemodialysis.
- •Self-reported allergy to linezolid or penicillin.
- •Unwilling or unable to attend follow-up visits.
研究组 & 干预措施
Linezolid 10 Day
Oral linezolid 600mg, taken twice a day for 10 days
干预措施: Group B, Linezolid 10d (Drug)
Benzathine Penicillin G
Single intramuscular injection of 2.4 million units of benzathine penicillin G
干预措施: Group A, Penicillin (Drug)
结局指标
主要结局
Response to Treatment
时间窗: 6 months
Percentage of linezolid participants with a 4-fold decrease or greater in the serum RPR titer by 180 days after treatment
次要结局
未报告次要终点
研究者
Jeffrey D Klausner
Clinical Professor
University of Southern California