NCT00683865已完成3 期
Prospective, Randomized, Double-blind, Multicenter, Multinational Study Comparing Efficacy and Safety of Moxifloxacin 400 mg po od for 14 Days With Ofloxacin 400 mg po Bid Plus Metronidazole 500 mg po Bid for 14 Days in Patients With Uncomplicated Pelvic Inflammatory Disease (PID)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 749
- 主要终点
- Clinical response 5 to 24 days after the last dose of study medication
研究概览
简要总结
Comparison of various antibiotics in treatment of uncomplicated pelvic inflammatory disease
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
- Double (Participant, Investigator)
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
- •Diagnosis of PID based on: pelvic discomfort- Direct lower abdominal tenderness;
- •Adnexal tenderness on bimanual vaginal examination,
- •Temperature > 38.0°C; - Elevated C-reactive protein value (CRP);
- •Signed PIC/IC
排除标准
- •Pregnancy
- •Abnormal lab values
研究组 & 干预措施
Arm 1
Active Comparator
干预措施: Ofloxacin (Drug)
Arm 2
Experimental
干预措施: Avelox (Moxifloxacin, BAY12-8039) (Drug)
结局指标
主要结局
Clinical response 5 to 24 days after the last dose of study medication
时间窗: 5 to 24 days after the last dose
次要结局
- Bacterial response at the test of cure visit and at the FU visit 28 to 42 days after last dose of study medication(visit 28 to 42 days after last dose)
- Clinical response at during-treatment visit (Day 4-7) and at follow-up 28 to 42 days after last dose((Day 4-7) and at follow-up 28 to 42 days after last dose)
- Reduction from baseline in pain report at the different assessment visits(Over the entire trial period (overall))
- Necessity for modifying antibiotic therapy at the during-treatment visit and TOC visit and necessity for institution of an antibiotic therapy at follow-up(Over the entire trial period (overall))
研究者
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