Single Center, Open Label, Controlled Study to Assess the Safety & Efficacy of Oral Ciprodiazole Versus Currently Used Ciprofloxacin & Metronidazole Tablets in Pelvi-abdominal Infections and Following IV Antibiotics in Post-operative Period
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 312
- 试验地点
- 1
- 主要终点
- Wounds healing
研究概览
简要总结
This study aims to assess the safety & efficacy of Oral Ciprodiazole® versus currently used Ciprofloxacin Tablets & Metronidazole tablets in pelvi-abdominal infections and following IV antibiotics in post-operative period, for pelvi-abdominal surgeries or acute conditions
详细描述
Primary Objective
- Primary Safety:
To compare safety of oral Ciprodiazole ® tablets (Ciprofloxacin/Metronidazole) versus currently used Ciprofloxacin Tablets & Metronidazole tablets for pelvi-abdominal infections, either non-operative or post-operative following IV antibiotics. 2. Primary Efficacy:
To compare efficacy of oral Ciprodiazole ® tablets (Ciprofolxacin/Metronidazole) versus currently used Ciprofloxacin Tablets & Metronidazole tablets for pelvi-abdominal infections, either non-operative or post-operative following IV antibiotics.
Secondary Objective
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Egyptian male and female patients aged between 18-65 years' old
- •Subjects having pelvi-abdominal infections such as and not limited to: Ulcerative Colitis, Diverticulitis, Cholecystitis and Pelvic Inflammatory Diseases (PID), as oophoritis and salpingo-oophoritis.
- •Subjects during post-operative period for pelvi-abdominal surgery and following IV medication with Metronidazole injection plus third generation cephalosporin.
- •Subjects who are willing to sign Informed Consent Form (ICF) and ready to comply with the protocol for the duration of the study
排除标准
- •Subjects with a history of hypersensitivity to any of the active ingredients of the treatments used
- •Subjects who are receiving or received any other antibiotics during the previous two weeks, rather than IV treatment in the first post-operative 48 hours, mentioned in the protocol
- •Subjects with Pelvi-abdominal infection and performed surgery after failure of oral antibiotics.
- •Subjects having surgeries such as colorectal surgeries.
- •Subjects with any medical condition requiring the usage of the following medications:
- •Drugs that induce microsomal liver enzymes, such as Phenytoin or Phenobarbital.
- •Drugs that decrease microsomal liver enzymes activity, such as cetrimide.
- •Theophylline
- •Corticosteroids
- •Antacids containing magnesium and aluminum, supplements and other products containing calcium, iron or zinc
- •Tizanidine
- •Subjects with uncontrolled diabetes mellitus; FBG > 200 mg/ml
- •All subjects with renal impairment (S. Creatinine > 1.5 mg/dL)
- •All subjects with hepatic impairment (Child-Pugh Score B-C)
- •Subjects with liver enzymes (SGOT & SGPT > 2 Normal range)
- •Pregnant or breast-feeding women
研究组 & 干预措施
Ciprodiazole
Ciprodiazole Tablets: (Ciprofloxacin 500 mg & Metronidazole 500 mg), 1 tablet every 12 hours up to 15 days
干预措施: Ciprodiazole (Drug)
Ciprofloxacin 500 mg Tablets & Metronidazole 500 mg tablets
Ciprofloxacin 500 mg Tablets: 1 tablet every 12 hours up to 15 days
Metronidazole 500 mg tablets: 1 tablet every 8 hours up to 10 days
干预措施: Ciprofloxacin Tablets & Metronidazole tablets (Drug)
结局指标
主要结局
Wounds healing
时间窗: Up to 15 Days
Complete healing of the of post-operative wounds
Resolution of pelvi-abdominal infection
时间窗: Up to 15 Days
Complete resolution for pelvi-abdominal infection, based on clinical response and/or pelvi-abdominal ultrasound and others
Safety and Tolerability
时间窗: Up to 15 Days
Incidence of serious/ non-serious adverse events
次要结局
- Change in Safety Lab measures(Up to 15 Days)
- Infection outcome(Up to 15 Days)
- Signs of post-operative wound infection(Up to 15 Days)
- Healing Days(Up to 15 Days)