Overview

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

Status:
Recruiting
Trial end date:
2023-12-31
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
MinaPharm Pharmaceuticals
Treatments:
Ciprofloxacin
Metronidazole
Criteria
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