CIPRO-001: Study to Assess the Safety & Efficacy of Oral Ciprodiazole Versus Currently Used Ciprofloxacin & Metronidazole
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Ciprodiazole Ciprodiazole Tablets: (Ciprofloxacin 500 mg & Metronidazole 500 mg), 1 tablet every 12 hours up to 15 days |
Drug: Ciprodiazole
Ciprofolxacin 500 mg / Metronidazole 500 mg
|
| Active Comparator: 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 |
Drug: Ciprofloxacin Tablets & Metronidazole tablets
Ciprofolxacin 500 mg + Metronidazole 500 mg
|
Outcome Measures
Primary Outcome Measures
- Safety and Tolerability [Up to 15 Days]
Incidence of serious/ non-serious adverse events
- Wounds healing [Up to 15 Days]
Complete healing of the of post-operative wounds
- Resolution of pelvi-abdominal infection [Up to 15 Days]
Complete resolution for pelvi-abdominal infection, based on clinical response and/or pelvi-abdominal ultrasound and others
Secondary Outcome Measures
- Signs of post-operative wound infection [Up to 15 Days]
Presence of any signs of post-operative wound infection such as redness, fever or wound discharge
- Change in Safety Lab measures [Up to 15 Days]
Change in Total Leukocyte count and serum Liver enzymes (SGOT, SGPT) between baseline (visit 1) to End of study visit (Follow up 2 V)
- Infection outcome [Up to 15 Days]
Complete resolution, improvement, failure or relapse of pelvi-abdominal infection, based on pelvi-abdominal ultrasound and/or clinical response
- Healing Days [Up to 15 Days]
Days for complete healing of post-operative wounds between the 2 groups
Eligibility Criteria
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.
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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:
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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.
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Subjects having surgeries such as colorectal surgeries.
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Subjects with any medical condition requiring the usage of the following medications:
-
Drugs that induce microsomal liver enzymes, such as Phenytoin or Phenobarbital.
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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)
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Subjects with liver enzymes (SGOT & SGPT > 2 Normal range)
-
Pregnant or breast-feeding women
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Faculty of Medicine - Menofia University | Shibīn Al Kawm | Menofia | Egypt | 32951 |
Sponsors and Collaborators
- MinaPharm Pharmaceuticals
Investigators
- Principal Investigator: Ahmed Dr El Kased, PhD, Faculty of Medicine - Menoufia University
Study Documents (Full-Text)
More Information
Publications
None provided.- CIPRO-001