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

MinaPharm Pharmaceuticals

Status and phase: Enrolling; Phase 4

Conditions: Surgical Site Infections

Treatments: Drug: Ciprodiazole; Drug: Ciprofloxacin Tablets & Metronidazole tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT05863832

CIPRO-001

Details and patient eligibility

About

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

Full 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

Enrollment: 312 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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312 participants in 2 patient groups

Ciprodiazole

Experimental group

Description:

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

Treatment:

Drug: Ciprodiazole

Ciprofloxacin 500 mg Tablets & Metronidazole 500 mg tablets

Active Comparator group

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

Treatment:

Drug: Ciprofloxacin Tablets & Metronidazole tablets