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

Surgical Site Infections Clinical Trial

— CIPRO-001  

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 Details — Status: Recruiting

Administrative data

• NCT number: NCT05863832
• Other study ID #: CIPRO-001
• Status: Recruiting
• Phase: Phase 4
• Start date: August 17, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: MinaPharm Pharmaceuticals
• Contact: Ahmed Dr El Kased, PhD
• Phone: +20 100 663 9418
• Email: elkased[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 312
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Infections
• Surgical Site Infections
• Surgical Wound Infection

Intervention

Drug:
• Ciprodiazole
Ciprofolxacin 500 mg / Metronidazole 500 mg
• Ciprofloxacin Tablets & Metronidazole tablets
Ciprofolxacin 500 mg + Metronidazole 500 mg

Locations

Country	Name	City	State
Egypt	Faculty of Medicine - Menofia University	Shibin Al Kawm	Menofia

Sponsors (1)

Lead Sponsor	Collaborator
MinaPharm Pharmaceuticals

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability	Incidence of serious/ non-serious adverse events	Up to 15 Days
Primary	Wounds healing	Complete healing of the of post-operative wounds	Up to 15 Days
Primary	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	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
Secondary	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
Secondary	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
Secondary	Healing Days	Days for complete healing of post-operative wounds between the 2 groups	Up to 15 Days