A Phase 3, Multicenter, Unblind, Non-Comparative Study To Confirm Efficacy And Safety Of Intravenous Metronidazole In Patients With Intrabdominal Infection In Combination With Intravenous Ceftriaxone
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 38
- 试验地点
- 15
- 主要终点
- Clinical Response: Response Rate (Data Review Committee Assessment)
研究概览
简要总结
The purpose of this study is to evaluate the clinical efficacy and safety in Japanese adult subjects with Intra-abdominal/Pelvic infections receiving Metronidazole IV 1,500-2,000 mg/day in combination with ceftriaxone sodium.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 79 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •16 years of age or older.
- •Diagnosed with intra-abdominal infections or pelvic inflammatory diseases.
- •Can be obtained a specimen for bacteriological efficacy assessment.
排除标准
- •Known or suspected hypersensitivity, intolerance or contraindication to Metronidazole, Ceftriaxone sodium, or other cephem antibiotics.
- •Severe renal dysfunction (creatinine clearance < 30 mL/min.) Reference: Cockcroft-Gault calculation formula.
- •Hepatic dysfunction (AST, ALT, total bilirubin > 3 times upper limit of normal range values).
- •Severe underlying disease; patients in which drug clinical evaluation is difficult because of confounding diseases.
研究组 & 干预措施
Metronidazole
Metronidazole will be administered at a dose of 500 mg TID (or QID for refractory or severe infection) in combination with ceftriaxone sodium
干预措施: Metronidazole (Drug)
Metronidazole
Metronidazole will be administered at a dose of 500 mg TID (or QID for refractory or severe infection) in combination with ceftriaxone sodium
干预措施: Ceftriaxone sodium (Drug)
结局指标
主要结局
Clinical Response: Response Rate (Data Review Committee Assessment)
时间窗: Baseline to EOT (up to 14 days), TOC
Clinical response was evaluated by the data review committee as effective (cured or improved), ineffective (not meeting "effective" criteria), or indeterminate at the end of treatment (EOT) and the test of cure (TOC: 7 days after EOT) based on clinical symptoms, ultrasound images and necessity of other treatment. TOC was the primary analysis of this outcome measure. Cured = clinical symptoms and abnormal findings at the start of the study were disappeared and considered other antibiotics were not required during the study and after the assessment time point. Improved = clinical symptoms and abnormal findings at the start of the study were improved and considered other antibiotics were not required during the study and after the assessment time point. Response rate was calculated from the following formula; "number of participants evaluated as effective" over "total number of participants that excluding ones evaluated as indeterminate" multiplied by 100.
次要结局
- Percentage of Participants Who Was Assessed as Appropriate to Continue Treatment (Investigator Assessment)(Baseline to Day 4)
- Bacteriological Response: Eradication Rate (Data Review Committee Assessment)(Baseline to Day 4, EOT (up to 14 days), TOC)
- Clinical Response: Response Rate (Investigator Assessment)(Baseline to EOT (up to 14 days), TOC)
- Bacteriological Response: Eradication Rate (Investigator Assessment)(Baseline to Day 4, EOT (up to 14 days), TOC)
- Number of Participants Analyzed for Population Pharmacokinetics (PK) of Metronidazole(Four samples were taken at any infusion after the first dosing: during infusion, immediately after end of infusion, between 15 and 60 minutes after end of infusion, and between 2 hours and immediately before the start of the next infusion.)