Surgical Site InfectionsPhase 4CIPRO-001NCT05863832
Study to Assess the Safety & Efficacy of Oral Ciprodiazole Versus Currently Used Ciprofloxacin & Metronidazole
A Phase 4 study testing Ciprodiazole and Ciprofloxacin Tablets & Metronidazole tablets in people with Surgical Site Infections, run by MinaPharm Pharmaceuticals at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Surgical Site Infections
- What is being tested?
- Ciprodiazole and Ciprofloxacin Tablets & Metronidazole tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Aug 2021to 31 Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 16Show fewer
- 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)
- Pregnant or breast-feeding women
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine - Menofia University
Shibīn al Kawm, Menofia, 32951
Ahmed Dr El kased, PhD, +20 100 663 9418, elkased@outlook.com
Abdelaziz Sakr, MBCCH, +20 109 0090 254, abdelaziz.ragab@med.menofia.edu.eg
About this study
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
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
Read the detailed description
Primary Objective
- 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.
- 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
- 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)
- 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
- Conditions
- Surgical Site Infections
- Being tested
- Ciprodiazole, Ciprofloxacin Tablets & Metronidazole tablets
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiprodiazoleDrug
Ciprofolxacin 500 mg / Metronidazole 500 mg
Ciprofloxacin Tablets & Metronidazole tabletsDrug
Ciprofolxacin 500 mg + Metronidazole 500 mg
| Study group | Role | What they receive |
|---|---|---|
| Ciprodiazole | Experimental | Ciprodiazole Tablets: (Ciprofloxacin 500 mg \& Metronidazole 500 mg), 1 tablet every 12 hours up to 15 days Receives: 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 Receives: Drug: Ciprofloxacin Tablets & Metronidazole tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
Incidence of serious/ non-serious adverse events
Measured: Up to 15 Days
Wounds healing
Complete healing of the of post-operative wounds
Measured: 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
Measured: Up to 15 Days
Secondary outcomes (4)
Signs of post-operative wound infection
Presence of any signs of post-operative wound infection such as redness, fever or wound discharge
Measured: Up to 15 Days
Change in Safety Lab measures
Change in Total Leukocyte count and serum Liver enzymes (SGOT, SGPT) between baseline (visit 1) to End of study visit (Follow up 2 V)
Measured: Up to 15 Days
Infection outcome
Complete resolution, improvement, failure or relapse of pelvi-abdominal infection, based on pelvi-abdominal ultrasound and/or clinical response
Measured: Up to 15 Days
Healing Days
Days for complete healing of post-operative wounds between the 2 groups
Measured: Up to 15 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start17 Aug 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- They will be randomized by computer, into 2 treatment groups; Ciprodiazole ® tablets (Ciprofloxacin/Metronidazole) versus currently used Ciprofloxacin Tablets \& Metronidazole tablets
- Masking
- None (open label)
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MinaPharm Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ahmed Dr El Kased, PhD, Principal investigator, Faculty of Medicine - Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05863832
- Sponsor's protocol ID
- CIPRO-001
- Acronym
- CIPRO-001
- Status last verified
- Apr 2023
- First submitted
- 6 Apr 2023
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05863832
- Acronym / sponsor ID
- CIPRO-001 / CIPRO-001
- Conditions
- Surgical Site Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- MinaPharm PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 17 Aug 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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
- 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)
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- They will be randomized by computer, into 2 treatment groups; Ciprodiazole ® tablets (Ciprofloxacin/Metronidazole) versus currently used Ciprofloxacin Tablets \& Metronidazole tablets
| Arm | Type | Receives |
|---|---|---|
| Ciprodiazole | Experimental | Drug: CiprodiazoleCiprodiazole Tablets: (Ciprofloxacin 500 mg \& Metronidazole 500 mg), 1 tablet every 12 hours up to 15 days |
| Ciprofloxacin 500 mg Tablets & Metronidazole 500 mg tablets | Active comparator | Drug: Ciprofloxacin Tablets & Metronidazole tabletsCiprofloxacin 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CiprodiazoleCiprofolxacin 500 mg / Metronidazole 500 mg | Drug | Ciprodiazole |
| Ciprofloxacin Tablets & Metronidazole tabletsCiprofolxacin 500 mg + Metronidazole 500 mg | Drug | Ciprofloxacin 500 mg Tablets & Metronidazole 500 mg tablets |
Primary outcome
Safety and Tolerability
Time frame: Up to 15 Days
Incidence of serious/ non-serious adverse events
Wounds healing
Time frame: Up to 15 Days
Complete healing of the of post-operative wounds
Resolution of pelvi-abdominal infection
Time frame: Up to 15 Days
Complete resolution for pelvi-abdominal infection, based on clinical response and/or pelvi-abdominal ultrasound and others
4 secondary outcomes
Signs of post-operative wound infection
Time frame: Up to 15 Days
Change in Safety Lab measures
Time frame: Up to 15 Days
Infection outcome
Time frame: Up to 15 Days
Healing Days
Time frame: Up to 15 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
Related trials for Surgical Site Infections
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer
Recruiting
Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control
Thyroid Diseases, Wound Healing
RecruitingObservational study
Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery
Surgical Site Infection
Not yet recruiting
Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study
Tooth Loss and Rehabillitation, Dental Implant Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Dr El Kased, PhD principal investigator
Faculty of Medicine - Menoufia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ciprodiazole and Ciprofloxacin Tablets & Metronidazole tablets in people with Surgical Site Infections, run by MinaPharm Pharmaceuticals at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Dr El Kased, PhD (+20 100 663 9418, elkased@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability (time frame: Up to 15 Days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2023.