Study to Assess the Safety & Efficacy of Oral Ciprodiazole Versus Currently Used Ciprofloxacin & Metronidazole (CIPRO-001)
Surgical Site Infections
About this trial
This is an interventional treatment trial for Surgical Site Infections
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
- Faculty of Medicine - Menofia UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Ciprodiazole
Ciprofloxacin 500 mg Tablets & Metronidazole 500 mg tablets
Ciprodiazole Tablets: (Ciprofloxacin 500 mg & Metronidazole 500 mg), 1 tablet every 12 hours up to 15 days
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