NCT01631201已完成2 期
A Phase 2b, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Safety and Efficacy of Rifalazil (25 Milligram) Compared With Azithromycin (1 Gram) for the Treatment of Uncomplicated Genital Chlamydia Trachomatis Infection in Women
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Proportion of subjects with microbiologic cure of chlamydia trachomatis infection at Day 22
研究概览
简要总结
This study will test the safety and effectiveness of an investigational antibiotic drug, rifalazil for the treatment of uncomplicated genital Chlamydia trachomatis infection. This study will examine the effects of 25 milligram of rifalazil compared with azithromycin 1 gram, which will be given as a single dose to women who have genital chlamydial infection.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female ≥ 19 years old diagnosed with genital chlamydia trachomatis infection.
- •Use an effective method of contraception.
- •Agree to be abstinent or to have partners use condoms for all sexual activities during the study.
排除标准
- •Subject or sexual partner is known to have gonorrhea.
- •History of repeated chlamydia trachomatis infection.
- •HIV, syphilis, or active Hepatitis B or C infection.
- •Treatment with antimicrobial therapy with known activity against chlamydia trachomatis within 4 weeks of enrollment.
研究组 & 干预措施
Rifalazil 25 milligram
Experimental
干预措施: Rifalazil 25 milligram (Drug)
Azithromycin 1 gram
Active Comparator
Single dose of Azithromycin 1 gram to be administered on Day 1.
干预措施: Azithromycin 1 gram (Drug)
结局指标
主要结局
Proportion of subjects with microbiologic cure of chlamydia trachomatis infection at Day 22
时间窗: Day 22
Microbiologic test result will be reported as positive or negative for chlamydia trachomatis.
次要结局
- Proportion of subjects with microbiologic cure of chlamydia trachomatis infection at Day 36.(Day 36)
- Number of subjects experiencing clinically significant laboratory abnormalities in the two treatment groups.(Day 36 (end of study))
- Number of subjects experiencing adverse events in the two treatment groups.(Day 36 (end of study))
研究者
研究点 (1)
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