Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2025-12-29 @ 12:05 PM
Study NCT ID:
NCT05863832
Status:
UNKNOWN
Last Update Posted:
2023-05-18
First Post:
2023-04-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Assess the Safety & Efficacy of Oral Ciprodiazole Versus Currently Used Ciprofloxacin & Metronidazole
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013530', 'term': 'Surgical Wound Infection'}], 'ancestors': [{'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002939', 'term': 'Ciprofloxacin'}, {'id': 'D008795', 'term': 'Metronidazole'}], 'ancestors': [{'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009593', 'term': 'Nitroimidazoles'}, {'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-20', 'size': 1956489, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-04-06T08:56', 'hasProtocol': True}, {'date': '2022-03-20', 'size': 833681, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-04-19T09:35', 'hasProtocol': False}, {'date': '2022-03-20', 'size': 150679, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-04-06T08:24', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'They will be randomized by computer, into 2 treatment groups; Ciprodiazole ® tablets (Ciprofloxacin/Metronidazole) versus currently used Ciprofloxacin Tablets \\& Metronidazole tablets'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 312}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-08', 'studyFirstSubmitDate': '2023-04-06', 'studyFirstSubmitQcDate': '2023-05-08', 'lastUpdatePostDateStruct': {'date': '2023-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and Tolerability', 'timeFrame': 'Up to 15 Days', 'description': 'Incidence of serious/ non-serious adverse events'}, {'measure': 'Wounds healing', 'timeFrame': 'Up to 15 Days', 'description': 'Complete healing of the of post-operative wounds'}, {'measure': 'Resolution of pelvi-abdominal infection', 'timeFrame': 'Up to 15 Days', 'description': 'Complete resolution for pelvi-abdominal infection, based on clinical response and/or pelvi-abdominal ultrasound and others'}], 'secondaryOutcomes': [{'measure': 'Signs of post-operative wound infection', 'timeFrame': 'Up to 15 Days', 'description': 'Presence of any signs of post-operative wound infection such as redness, fever or wound discharge'}, {'measure': 'Change in Safety Lab measures', 'timeFrame': 'Up to 15 Days', 'description': 'Change in Total Leukocyte count and serum Liver enzymes (SGOT, SGPT) between baseline (visit 1) to End of study visit (Follow up 2 V)'}, {'measure': 'Infection outcome', 'timeFrame': 'Up to 15 Days', 'description': 'Complete resolution, improvement, failure or relapse of pelvi-abdominal infection, based on pelvi-abdominal ultrasound and/or clinical response'}, {'measure': 'Healing Days', 'timeFrame': 'Up to 15 Days', 'description': 'Days for complete healing of post-operative wounds between the 2 groups'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Surgical Site Infections']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': 'Primary Objective\n\n1. Primary Safety:\n\n 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.\n2. Primary Efficacy:\n\nTo 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.\n\nSecondary Objective\n\n1. Secondary Safety:\n\n * Presence of any signs/symptoms of post-operative wound infection such as redness, fever or wound discharge.\n * Presence of undesirable effects on total leukocyte count and liver enzymes (SGOT\\& SGPT)\n2. Secondary Efficacy:\n\n * To compare the complete resolution or improvement of Pelvi-abdominal infection between ciprodiazole® versus combined treatment, based on pelvi-abdominal ultrasound and others\n * To compare the days for complete healing of post-operative wounds between ciprodiazole® versus combined treatment\n\nSTUDY DURATION:\n\n* Subjects will be enrolled for 12 months including screening visit\n* Follow up for 15 days from enrolment\n\nSTUDY POPULATION:\n\n312 Egyptian Patients with pelvi-abdominal infection or started IV antibiotics in post-operative period, for pelvi - abdominal surgeries and/or acute conditions\n\nASSESSMENT SCHEDULE:\n\nSubjects will be enrolled for 12 months including screening visit\n\n* Visit 1: Screening and treatment initiation visit, Day 0\n* Follow-up 1 visit: Day 8 (+/-) 3 days\n* Follow-up 2 visit \\& End of study visit: Day 15 (+/-) 3 days'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Egyptian male and female patients aged between 18-65 years' old\n2. 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.\n3. Subjects during post-operative period for pelvi-abdominal surgery and following IV medication with Metronidazole injection plus third generation cephalosporin.\n4. Subjects who are willing to sign Informed Consent Form (ICF) and ready to comply with the protocol for the duration of the study\n\nExclusion Criteria:\n\n1. Subjects with a history of hypersensitivity to any of the active ingredients of the treatments used\n2. 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\n3. Subjects with Pelvi-abdominal infection and performed surgery after failure of oral antibiotics.\n4. Subjects having surgeries such as colorectal surgeries.\n5. Subjects with any medical condition requiring the usage of the following medications:\n\n * Drugs that induce microsomal liver enzymes, such as Phenytoin or Phenobarbital.\n * Drugs that decrease microsomal liver enzymes activity, such as cetrimide.\n * Theophylline\n * Corticosteroids\n * Antacids containing magnesium and aluminum, supplements and other products containing calcium, iron or zinc\n * Tizanidine\n6. Subjects with uncontrolled diabetes mellitus; FBG \\> 200 mg/ml\n7. All subjects with renal impairment (S. Creatinine \\> 1.5 mg/dL)\n8. All subjects with hepatic impairment (Child-Pugh Score B-C)\n9. Subjects with liver enzymes (SGOT \\& SGPT \\> 2 Normal range)\n10. Pregnant or breast-feeding women"}, 'identificationModule': {'nctId': 'NCT05863832', 'acronym': 'CIPRO-001', 'briefTitle': 'Study to Assess the Safety & Efficacy of Oral Ciprodiazole Versus Currently Used Ciprofloxacin & Metronidazole', 'organization': {'class': 'INDUSTRY', 'fullName': 'MinaPharm Pharmaceuticals'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CIPRO-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ciprodiazole', 'description': 'Ciprodiazole Tablets: (Ciprofloxacin 500 mg \\& Metronidazole 500 mg), 1 tablet every 12 hours up to 15 days', 'interventionNames': ['Drug: Ciprodiazole']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ciprofloxacin 500 mg Tablets & Metronidazole 500 mg tablets', 'description': 'Ciprofloxacin 500 mg Tablets: 1 tablet every 12 hours up to 15 days\n\nMetronidazole 500 mg tablets: 1 tablet every 8 hours up to 10 days', 'interventionNames': ['Drug: Ciprofloxacin Tablets & Metronidazole tablets']}], 'interventions': [{'name': 'Ciprodiazole', 'type': 'DRUG', 'description': 'Ciprofolxacin 500 mg / Metronidazole 500 mg', 'armGroupLabels': ['Ciprodiazole']}, {'name': 'Ciprofloxacin Tablets & Metronidazole tablets', 'type': 'DRUG', 'description': 'Ciprofolxacin 500 mg + Metronidazole 500 mg', 'armGroupLabels': ['Ciprofloxacin 500 mg Tablets & Metronidazole 500 mg tablets']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32951', 'city': 'Shibīn al Kawm', 'state': 'Menofia', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed Dr El kased, PhD', 'role': 'CONTACT', 'email': 'elkased@outlook.com', 'phone': '+20 100 663 9418'}, {'name': 'Abdelaziz Sakr, MBCCH', 'role': 'CONTACT', 'email': 'abdelaziz.ragab@med.menofia.edu.eg', 'phone': '+20 109 0090 254'}], 'facility': 'Faculty of Medicine - Menofia University', 'geoPoint': {'lat': 30.55258, 'lon': 31.00904}}], 'centralContacts': [{'name': 'Ahmed Dr El Kased, PhD', 'role': 'CONTACT', 'email': 'elkased@outlook.com', 'phone': '+20 100 663 9418'}, {'name': 'Abdelaziz Dr Sakr, MBBCH', 'role': 'CONTACT', 'email': 'abdelaziz.ragab@med.menofia.edu.eg', 'phone': '+20 109 009 0254'}], 'overallOfficials': [{'name': 'Ahmed Dr El Kased, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine - Menoufia University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MinaPharm Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}