Study to Assess the Safety & Efficacy of Oral Ciprodiazole Versus Currently Used Ciprofloxacin & Metronidazole

Study Overview
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Brief Summary
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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

Detailed Description
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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. 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 Secondary Safety: Presence of any signs/symptoms of post-operative wound infection such as redness, fever or wound discharge. Presence of undesirable effects on total leukocyte count and liver enzymes (SGOT& SGPT) Secondary Efficacy: To compare the complete resolution or improvement of Pelvi-abdominal infection between ciprodiazole® versus combined treatment, based on pelvi-abdominal ultrasound and others To compare the days for complete healing of post-operative wounds between ciprodiazole® versus combined treatment STUDY DURATION: Subjects will be enrolled for 12 months including screening visit Follow up for 15 days from enrolment STUDY POPULATION: 312 Egyptian Patients with pelvi-abdominal infection or started IV antibiotics in post-operative period, for pelvi - abdominal surgeries and/or acute conditions ASSESSMENT SCHEDULE: Subjects will be enrolled for 12 months including screening visit Visit 1: Screening and treatment initiation visit, Day 0 Follow-up 1 visit: Day 8 (+/-) 3 days Follow-up 2 visit & End of study visit: Day 15 (+/-) 3 days

Official Title
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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

Conditions
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Surgical Site Infections

Intervention / Treatment
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* Drug: Ciprodiazole
* Drug: Ciprofloxacin Tablets & Metronidazole tablets


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: They will be randomized by computer, into 2 treatment groups; Ciprodiazole ® tablets (Ciprofloxacin/Metronidazole) versus currently used Ciprofloxacin Tablets & Metronidazole tablets
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ciprodiazole<br>Ciprodiazole Tablets: (Ciprofloxacin 500 mg & Metronidazole 500 mg), 1 tablet every 12 hours up to 15 days | Drug: Ciprodiazole<br>* Ciprofolxacin 500 mg / Metronidazole 500 mg<br>|
| Active Comparator: Ciprofloxacin 500 mg Tablets & Metronidazole 500 mg tablets<br>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 | Drug: Ciprofloxacin Tablets & Metronidazole tablets<br>* Ciprofolxacin 500 mg + Metronidazole 500 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability | Incidence of serious/ non-serious adverse events | Up to 15 Days | 
| Wounds healing | Complete healing of the of post-operative wounds | Up to 15 Days | 
| Resolution of pelvi-abdominal infection | Complete resolution for pelvi-abdominal infection, based on clinical response and/or pelvi-abdominal ultrasound and others | Up to 15 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Signs of post-operative wound infection | Presence of any signs of post-operative wound infection such as redness, fever or wound discharge | Up to 15 Days | 
| Change in Safety Lab measures | Change in Total Leukocyte count and serum Liver enzymes (SGOT, SGPT) between baseline (visit 1) to End of study visit (Follow up 2 V) | Up to 15 Days | 
| Infection outcome | Complete resolution, improvement, failure or relapse of pelvi-abdominal infection, based on pelvi-abdominal ultrasound and/or clinical response | Up to 15 Days | 
| Healing Days | Days for complete healing of post-operative wounds between the 2 groups | Up to 15 Days |