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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05863832
Other study ID # CIPRO-001
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


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
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