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

Status Recruiting

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 ;

Related Conditions & MeSH terms

• Infections
• Surgical Site Infections
• Surgical Wound Infection

• 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