Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2025-12-24 @ 9:26 PM
NCT ID:
NCT05863832
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
Study:
NCT05863832
Study Brief:
Protocol Section:
NCT05863832