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

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

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

Study Overview

• Status: Recruiting
• Conditions: Surgical Site Infections
• Intervention / Treatment: Drug: Ciprodiazole; Drug: Ciprofloxacin Tablets & Metronidazole tablets

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

• Study Type: Interventional
• Enrollment (Anticipated): 312
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ahmed Dr El kased, PhD; Phone Number: +20 100 663 9418; Email: elkased@outlook.com
• Study Contact Backup: Name: Abdelaziz Dr Sakr, MBBCH; Phone Number: +20 109 009 0254; Email: abdelaziz.ragab@med.menofia.edu.eg

Study Locations

• Egypt
  • Menofia
    • Shibīn Al Kawm, Menofia, Egypt, 32951
      • Recruiting
      • Faculty of Medicine - Menofia University
      • Contact: Ahmed Dr El kased, PhD; Phone Number: +20 100 663 9418; Email: elkased@outlook.com
      • Contact: Abdelaziz Sakr, MBCCH; Phone Number: +20 109 0090 254; Email: abdelaziz.ragab@med.menofia.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Egyptian male and female patients aged between 18-65 years' old
2. 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.
3. Subjects during post-operative period for pelvi-abdominal surgery and following IV medication with Metronidazole injection plus third generation cephalosporin.
4. 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:

1. Subjects with a history of hypersensitivity to any of the active ingredients of the treatments used
2. 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
3. Subjects with Pelvi-abdominal infection and performed surgery after failure of oral antibiotics.
4. Subjects having surgeries such as colorectal surgeries.

5. 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
6. Subjects with uncontrolled diabetes mellitus; FBG > 200 mg/ml
7. All subjects with renal impairment (S. Creatinine > 1.5 mg/dL)
8. All subjects with hepatic impairment (Child-Pugh Score B-C)
9. Subjects with liver enzymes (SGOT & SGPT > 2 Normal range)
10. Pregnant or breast-feeding women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: MinaPharm Pharmaceuticals
• Investigators: Principal Investigator: Ahmed Dr El Kased, PhD, Faculty of Medicine - Menoufia University

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: April 6, 2023
• First Submitted That Met QC Criteria: May 8, 2023
• First Posted (Actual): May 18, 2023

Study Record Updates

• Last Update Posted (Actual): May 18, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Wound Infection; Infections; Surgical Wound Infection; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Cytochrome P-450 CYP1A2 Inhibitors; Metronidazole; Ciprofloxacin
• Other Study ID Numbers: CIPRO-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No