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Study to Assess the Safety & Efficacy of Oral Ciprodiazole Versus Currently Used Ciprofloxacin & Metronidazole — CIPRO-001  

Surgical Site Infections Clinical Trial

Official title:
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

Clinical Trial 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

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05863832
Study type Interventional
Source MinaPharm Pharmaceuticals
Contact Ahmed Dr El Kased, PhD
Phone +20 100 663 9418
Email elkased@outlook.com
Status Recruiting
Phase Phase 4
Start date August 17, 2021
Completion date December 31, 2023
View Details
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