A Prospective, Randomized, Double Dummy, Double Blind, Multi-center Multinational Trial Comparing the Efficacy and Safety of Moxifloxacin 400 mg PO QD 24 Hours for 14 Days to That of Levofloxacin 500 mg PO QD 24 Hours Plus Metronidazole 500 mg BID for 14 Days in Subjects With an Uncomplicated Pelvic Inflammatory Disease (PID). Moxifloxacin, Metronidazole, and Levofloxacin in Asia (MONALISA Study)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 460
- 主要终点
- Clinical Response 7 to 14 Days After Completion of Study Drug Therapy in Per Protocol (PP) Population
研究概览
简要总结
To assess the efficacy and safety of oral moxifloxacin compared to oral levofloxacin plus oral metronidazole in uncomplicated pelvic inflammatory disease (PID)
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 uncomplicated PID based on the absence of pelvic or tubo-ovarian abscess at pelvic ultrasound and/or laparoscopic examination.
排除标准
- •Subjects with impaired liver and renal function; known hypersensitivity to study drugs, related compounds or any of the excipients.
研究组 & 干预措施
Moxifloxacin
Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
干预措施: Moxifloxacin (Avelox, BAY12-8039) (Drug)
Levofloxacin plus Metronidazole
Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
干预措施: Levofloxacin & Metronidazole (Drug)
结局指标
主要结局
Clinical Response 7 to 14 Days After Completion of Study Drug Therapy in Per Protocol (PP) Population
时间窗: 7 - 14 days after completion of study drug therapy
Clinical cure was defined as: Reduction of the tenderness score (modified McCormack) by \> 70% and apyrexia (rectal/tympanic/oral temperature value \< 38.0°C or axillary temperature value \< 37.5°C) and white blood cell count \< 10,500/mm\^3.
次要结局
- Clinical Response 7 to 14 Days After Completion of Study Drug Therapy on Intent To Treat (ITT) Population(7 - 14 days after completion of study drug therapy)
- Clinical Response on Treatment for Per Protocol Population(4 - 7 days after start of therapy)
- Clinical Response on Treatment for Intent To Treat Population(4 - 7 days after start of therapy)
- Bacteriological Response at Test Of Cure (TOC) Visit Microbiologically Valid(7 - 14 days at TOC visit)
- Bacteriological Response at Test Of Cure (TOC) Visit in Intent To Treat Population With Causative Organism(7 - 14 days at TOC visit)
- Bacteriological Response at Follow-up Visit Microbiologically Valid(28 - 42 days after completion of study drug therapy)
- Bacteriological Response at Follow-up Visit in Intent To Treat Population With Causative Organism(28 - 42 days after completion of study drug therapy)
- Number of Subjects Who Received Alternative Medicine(Up to 42 days after end of treatment)
- Clinical Response at Follow-up Visit on Per Protocol Population(28 - 42 days after completion of study drug therapy)
- Clinical Response at Follow-up Visit on Intent To Treat Population(28 - 42 days after completion of study drug therapy)