Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2025-12-29 @ 12:05 PM
Study NCT ID:
NCT05863832
Status:
UNKNOWN
Last Update Posted:
2023-05-18
First Post:
2023-04-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Assess the Safety & Efficacy of Oral Ciprodiazole Versus Currently Used Ciprofloxacin & Metronidazole
Sponsor:
MinaPharm Pharmaceuticals
Organization:
Study Overview
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:
UNKNOWN
Status Verified Date:
2023-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CIPRO-001
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
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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: