Trial Evaluating the Clinical Efficacy of Cefixime for Treatment of Early Syphilis in Non-pregnant Women
试验速览
- 阶段
- 1 期
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Quantitative RPR titer change
研究概览
简要总结
Hypotheses The antibiotic, Cefixime, for use in non-pregnant women with early syphilis will be efficacious and safe.
Primary Objective The primary objective of the study is to demonstrate the efficacy, as measured by a 4 fold decrease in Rapid Plasma Reagin (RPR) titer from baseline to 6 months after treatment, with Cefixime 400mg taken orally two times a day for 10 consecutive days.
Secondary Objective The secondary objective of the study is to determine the safety, as measured by the number of grade 3 or greater toxicities experienced, using the NIH/NCI toxicity score, during or after treatment with Cefixime 400mg taken orally two times a day for 10 consecutive days.
详细描述
Hypotheses The antibiotic, Cefixime, for use in non-pregnant women with early syphilis will be efficacious and safe.
Primary Objective The primary objective of the study is to demonstrate the efficacy, as measured by a 4 fold decrease in Rapid Plasma Reagin (RPR) titer from baseline to 6 months after treatment, with Cefixime 400mg taken orally two times a day for 10 consecutive days.
Secondary Objective The secondary objective of the study is to determine the safety, as measured by the number of grade 3 or greater toxicities experienced, using the NIH/NCI toxicity score (10), during or after treatment with Cefixime 400mg taken orally two times a day for 10 consecutive days.
Methods Study design This is a randomized, non-comparative, open-label study assessing the efficacy and safety of cefixime 400mg taken orally two times a day for 10 consecutive days in non-pregnant women with early syphilis infection.
Study population and enrolment sites Numerous regions of Brazil have experienced increases in syphilis diagnoses during the previous 5 years The study sites were chosen from three cities in three separate regions (states) of Brazil based on: (1) increases in syphilis case reports, (2) access to clinics where patients are screened and treated for syphilis; (3) willingness of clinic sites and staff to participate in this research, and (4) the availability of experienced researchers with experience in studying syphilis to serve as co-investigators.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, 18 years of age or older
- •Non-pregnant
- •Able to provide informed consent
- •Test positive for syphilis with a positive TPPA AND an RPR titer equal to or greater than 1:8
- •Non-cephalosporin allergic
- •Non-penicillin allergic
- •Agree to be called once a day by study staff to be reminded to take study drug
- •Able to swallow pills
- •Willing to attend follow-up visits at 3, 6, and 9 months after completion of the study treatment
- •Willing to take oral contraceptive or use condom to prevent pregnancy during the study period
- •HIV negative
排除标准
- •Female under 18 years of age 2) HIV positive 3) Pregnancy test positive or clinical pregnancy 4) Prior history of syphilis or syphilis treatment within 6 months of study screening 5) Allergy to penicillin or cephalosporins (including allergy to cefixime) 6) In the judgment of the interviewer, has a medical condition or other factor that might affect their ability to follow the protocol 7) Previous enrollment in the study 8) Presenting a condition that would not allow reliable informed consent (alcohol abuse or substance misuse) 9) Lacking mental capacity to give informed consent to participation
研究组 & 干预措施
Cefixime
cefixime 400mg taken orally two times a day for 10 consecutive days in non-pregnant women with early syphilis infection.
干预措施: Cefixime (Drug)
Benzathine penicillin
To benchmark the performance of benzathine penicillin in the study population being used for cefixime, the investigators will include a contemporary arm of participants that will receive standard of care treatment with benzathine penicillin according to the Brazil national STI treatment guidelines. The investigators will use a ratio of 2 patients receiving cefixime to 1 patient receiving benzathine penicillin.
干预措施: Benzathine penicillin 2.4 million units (Drug)
结局指标
主要结局
Quantitative RPR titer change
时间窗: 6 months following last dose of Cefixime 400 mg
RPR titer response at 6 months
次要结局
- Number of participants with treatment-related adverse events as assessed by CTCAE with cefixime(Daily after the first dose of cefixime 400mg orally through 10 days after the first dose)
- The number of participants reporting tolerability of cefixime(Daily after the first dose of cefixime 400mg orally through 10 days after the first dose and qualitative overall assessment of tolerability measured via questionnaire 14 days after the first dose of cefixime)
研究者
Melanie Taylor
Medical Offier
World Health Organization