Clinical trial NCT05863832: Study to Assess the Safety & Efficacy of Oral Ciprodiazole Versus Currently Used Ciprofloxacin & Metronidazole
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Surgical Site Infections
Lead sponsor: MinaPharm Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2023-05-18
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: They will be randomized by computer, into 2 treatment groups; Ciprodiazole ® tablets (Ciprofloxacin/Metronidazole) versus currently used Ciprofloxacin Tablets \& Metronidazole tablets
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: Safety and Tolerability
timeFrame: Up to 15 Days
measure: Wounds healing
timeFrame: Up to 15 Days
measure: Resolution of pelvi-abdominal infection
timeFrame: Up to 15 Days
Secondary outcomes:
measure: Signs of post-operative wound infection
timeFrame: Up to 15 Days
measure: Change in Safety Lab measures
timeFrame: Up to 15 Days
measure: Infection outcome
timeFrame: Up to 15 Days
measure: Healing Days
timeFrame: Up to 15 Days
Other outcomes:
Locations:
city: Shibīn Al Kawm
country: Egypt
facility: Faculty of Medicine - Menofia University
state: Menofia
Study officials:
affiliation: Faculty of Medicine - Menoufia University
name: Ahmed Dr El Kased, PhD
role: PRINCIPAL_INVESTIGATOR
References: