NCT05863832

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 312 (estimated)
• Sponsor: MinaPharm Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Detailed description

Primary Objective 1. 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 1. 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) 2. 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

Conditions

• Surgical Site Infections

Interventions

Type	Name	Description
DRUG	Ciprodiazole	Ciprofolxacin 500 mg / Metronidazole 500 mg
DRUG	Ciprofloxacin Tablets & Metronidazole tablets	Ciprofolxacin 500 mg + Metronidazole 500 mg

Timeline

• Start date: 2021-08-17
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2023-05-18
• Last updated: 2023-05-18

Locations

1 site across 1 country: Egypt