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

NCT05863832 | Unknown Phase 4 DMC

• 1 other identifier: CIPRO-001
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

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

Conditions

Surgical Site Infections

Outcome Measures

Primary Outcomes (3)

• Safety and Tolerability

  Incidence of serious/ non-serious adverse events

  Up to 15 Days

• Wounds healing

  Complete healing of the of post-operative wounds

  Up to 15 Days

• Resolution of pelvi-abdominal infection

  Complete resolution for pelvi-abdominal infection, based on clinical response and/or pelvi-abdominal ultrasound and others

  Up to 15 Days

Secondary Outcomes (4)

• Signs of post-operative wound infection

  Up to 15 Days

• Change in Safety Lab measures

  Up to 15 Days

• Infection outcome

  Up to 15 Days

• Healing Days

  Up to 15 Days

Study Arms (2)

Ciprodiazole

EXPERIMENTAL

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

Drug: Ciprodiazole

Ciprofloxacin 500 mg Tablets & Metronidazole 500 mg tablets

ACTIVE COMPARATOR

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

Drug: Ciprofloxacin Tablets & Metronidazole tablets

Interventions

Ciprodiazole DRUG

Ciprofolxacin 500 mg / Metronidazole 500 mg

Ciprodiazole

Ciprofloxacin Tablets & Metronidazole tablets DRUG

Ciprofolxacin 500 mg + Metronidazole 500 mg

Ciprofloxacin 500 mg Tablets & Metronidazole 500 mg tablets

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Egyptian male and female patients aged between 18-65 years' old
• 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.
• Subjects during post-operative period for pelvi-abdominal surgery and following IV medication with Metronidazole injection plus third generation cephalosporin.
• Subjects who are willing to sign Informed Consent Form (ICF) and ready to comply with the protocol for the duration of the study

You may not qualify if:

• Subjects with a history of hypersensitivity to any of the active ingredients of the treatments used
• 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
• Subjects with Pelvi-abdominal infection and performed surgery after failure of oral antibiotics.
• Subjects having surgeries such as colorectal surgeries.
• 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
• Subjects with uncontrolled diabetes mellitus; FBG \> 200 mg/ml
• All subjects with renal impairment (S. Creatinine \> 1.5 mg/dL)
• All subjects with hepatic impairment (Child-Pugh Score B-C)
• Subjects with liver enzymes (SGOT \& SGPT \> 2 Normal range)

Sponsors & Collaborators

• MinaPharm Pharmaceuticals: lead

Study Sites (1)

Faculty of Medicine - Menofia University

Shibīn al Kawm, Menofia, 32951, Egypt

RECRUITING

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Ciprofloxacin; Metronidazole

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Ahmed Dr El Kased, PhD

  Faculty of Medicine - Menoufia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Dr El Kased, PhD

CONTACT

+20 100 663 9418; elkased@outlook.com

Abdelaziz Dr Sakr, MBBCH

CONTACT

+20 109 009 0254; abdelaziz.ragab@med.menofia.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: They will be randomized by computer, into 2 treatment groups; Ciprodiazole ® tablets (Ciprofloxacin/Metronidazole) versus currently used Ciprofloxacin Tablets \& Metronidazole tablets

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: May 18, 2023
• Study Start: August 17, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 18, 2023

Record last verified: 2023-04

Locations

EG (1)