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

Primary Purpose

Surgical Site Infections

Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Ciprodiazole
Ciprofloxacin Tablets & Metronidazole tablets
Sponsored by
MinaPharm Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgical Site Infections

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Egyptian male and female patients aged between 18-65 years' old 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. Subjects during post-operative period for pelvi-abdominal surgery and following IV medication with Metronidazole injection plus third generation cephalosporin. 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: Subjects with a history of hypersensitivity to any of the active ingredients of the treatments used 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 Subjects with Pelvi-abdominal infection and performed surgery after failure of oral antibiotics. Subjects having surgeries such as colorectal surgeries. 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 Subjects with uncontrolled diabetes mellitus; FBG > 200 mg/ml All subjects with renal impairment (S. Creatinine > 1.5 mg/dL) All subjects with hepatic impairment (Child-Pugh Score B-C) Subjects with liver enzymes (SGOT & SGPT > 2 Normal range) Pregnant or breast-feeding women

Sites / Locations

  • Faculty of Medicine - Menofia UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ciprodiazole

Ciprofloxacin 500 mg Tablets & Metronidazole 500 mg tablets

Arm Description

Ciprodiazole Tablets: (Ciprofloxacin 500 mg & Metronidazole 500 mg), 1 tablet every 12 hours up to 15 days

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

Outcomes

Primary Outcome Measures

Safety and Tolerability
Incidence of serious/ non-serious adverse events
Wounds healing
Complete healing of the of post-operative wounds
Resolution of pelvi-abdominal infection
Complete resolution for pelvi-abdominal infection, based on clinical response and/or pelvi-abdominal ultrasound and others

Secondary Outcome Measures

Signs of post-operative wound infection
Presence of any signs of post-operative wound infection such as redness, fever or wound discharge
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)
Infection outcome
Complete resolution, improvement, failure or relapse of pelvi-abdominal infection, based on pelvi-abdominal ultrasound and/or clinical response
Healing Days
Days for complete healing of post-operative wounds between the 2 groups

Full Information

First Posted
April 6, 2023
Last Updated
May 8, 2023
Sponsor
MinaPharm Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05863832
Brief Title
Study to Assess the Safety & Efficacy of Oral Ciprodiazole Versus Currently Used Ciprofloxacin & Metronidazole
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 17, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MinaPharm Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 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. 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 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) 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
They will be randomized by computer, into 2 treatment groups; Ciprodiazole ® tablets (Ciprofloxacin/Metronidazole) versus currently used Ciprofloxacin Tablets & Metronidazole tablets
Masking
None (Open Label)
Allocation
Randomized
Enrollment
312 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ciprodiazole
Arm Type
Experimental
Arm Description
Ciprodiazole Tablets: (Ciprofloxacin 500 mg & Metronidazole 500 mg), 1 tablet every 12 hours up to 15 days
Arm Title
Ciprofloxacin 500 mg Tablets & Metronidazole 500 mg tablets
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Ciprodiazole
Intervention Description
Ciprofolxacin 500 mg / Metronidazole 500 mg
Intervention Type
Drug
Intervention Name(s)
Ciprofloxacin Tablets & Metronidazole tablets
Intervention Description
Ciprofolxacin 500 mg + Metronidazole 500 mg
Primary Outcome Measure Information:
Title
Safety and Tolerability
Description
Incidence of serious/ non-serious adverse events
Time Frame
Up to 15 Days
Title
Wounds healing
Description
Complete healing of the of post-operative wounds
Time Frame
Up to 15 Days
Title
Resolution of pelvi-abdominal infection
Description
Complete resolution for pelvi-abdominal infection, based on clinical response and/or pelvi-abdominal ultrasound and others
Time Frame
Up to 15 Days
Secondary Outcome Measure Information:
Title
Signs of post-operative wound infection
Description
Presence of any signs of post-operative wound infection such as redness, fever or wound discharge
Time Frame
Up to 15 Days
Title
Change in Safety Lab measures
Description
Change in Total Leukocyte count and serum Liver enzymes (SGOT, SGPT) between baseline (visit 1) to End of study visit (Follow up 2 V)
Time Frame
Up to 15 Days
Title
Infection outcome
Description
Complete resolution, improvement, failure or relapse of pelvi-abdominal infection, based on pelvi-abdominal ultrasound and/or clinical response
Time Frame
Up to 15 Days
Title
Healing Days
Description
Days for complete healing of post-operative wounds between the 2 groups
Time Frame
Up to 15 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Egyptian male and female patients aged between 18-65 years' old 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. Subjects during post-operative period for pelvi-abdominal surgery and following IV medication with Metronidazole injection plus third generation cephalosporin. 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: Subjects with a history of hypersensitivity to any of the active ingredients of the treatments used 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 Subjects with Pelvi-abdominal infection and performed surgery after failure of oral antibiotics. Subjects having surgeries such as colorectal surgeries. 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 Subjects with uncontrolled diabetes mellitus; FBG > 200 mg/ml All subjects with renal impairment (S. Creatinine > 1.5 mg/dL) All subjects with hepatic impairment (Child-Pugh Score B-C) Subjects with liver enzymes (SGOT & SGPT > 2 Normal range) Pregnant or breast-feeding women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Dr El Kased, PhD
Phone
+20 100 663 9418
Email
elkased@outlook.com
First Name & Middle Initial & Last Name or Official Title & Degree
Abdelaziz Dr Sakr, MBBCH
Phone
+20 109 009 0254
Email
abdelaziz.ragab@med.menofia.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Dr El Kased, PhD
Organizational Affiliation
Faculty of Medicine - Menoufia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine - Menofia University
City
Shibīn Al Kawm
State/Province
Menofia
ZIP/Postal Code
32951
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Dr El kased, PhD
Phone
+20 100 663 9418
Email
elkased@outlook.com
First Name & Middle Initial & Last Name & Degree
Abdelaziz Sakr, MBCCH
Phone
+20 109 0090 254
Email
abdelaziz.ragab@med.menofia.edu.eg

12. IPD Sharing Statement

Learn more about this trial

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

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