Ignite Creation Date:
2025-12-25 @ 3:14 AM
Ignite Modification Date:
2025-12-26 @ 1:52 AM
Study NCT ID:
NCT05916105
Status:
COMPLETED
Last Update Posted:
2023-06-23
First Post:
2023-06-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ciprofloxacin Utilization and Adverse Events Occurrence in Community Pharmacy Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002939', 'term': 'Ciprofloxacin'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 151}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-13', 'studyFirstSubmitDate': '2023-06-13', 'studyFirstSubmitQcDate': '2023-06-13', 'lastUpdatePostDateStruct': {'date': '2023-06-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Indications', 'timeFrame': '6 months', 'description': 'Appropriate Indications of ciprofloxacin (frequency )'}, {'measure': 'ciprofloxacin prescription (frequency )', 'timeFrame': '6 months', 'description': 'Number of appropriate ciprofloxacin prescription'}, {'measure': 'adverse events', 'timeFrame': '6 months', 'description': 'adverse events occured during ciprofloxacin therapy (frequency )'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ciprofloxacin', 'Use evaluation', 'Drug interaction'], 'conditions': ['Ciprofloxacin Adverse Reaction']}, 'referencesModule': {'references': [{'pmid': '2301191', 'type': 'BACKGROUND', 'citation': 'Goldman MP. Ciprofloxacin drug utilization review and prospective drug use evaluation. DICP. 1990 Jan;24(1):82-6. doi: 10.1177/106002809002400115.'}, {'pmid': '8736621', 'type': 'BACKGROUND', 'citation': 'Davis R, Markham A, Balfour JA. Ciprofloxacin. An updated review of its pharmacology, therapeutic efficacy and tolerability. Drugs. 1996 Jun;51(6):1019-74. doi: 10.2165/00003495-199651060-00010.'}]}, 'descriptionModule': {'briefSummary': 'Background: Ciprofloxacin is a fluoroquinolone that is commonly used to treat a variety of diseases. Ciprofloxacin resistance is rising, resulting in suboptimal patient care. The goal of this study was to evaluate ciprofloxacin use in the community in terms of acceptable prescription, dose, frequency, and duration of use.\n\nMethods: A cross-sectional research was done in Egyptian community pharmacies by community pharmacists. Patients who were administered oral ciprofloxacin during the research period were included.', 'detailedDescription': "From September 2021 to February 2022, a cross-sectional, research was undertaken to evaluate ciprofloxacin usage. The investigation was carried out by community pharmacists in seven Egyptian community pharmacies.\n\nData Collection: data gathered from pharmacy patients' records on a data collection form that included the factors indicated. The General Symptoms Questionnaire, physical examination, and blood testing were used to identify adverse occurrences.\n\nStudy variables:\n\n* age, gender, pregnancy/lactation\n* Department/indication\n* Dose, Frequency, Duration, Adverse events, Drug interactions.\n\nData was categorized and analyzed using appropriate software."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "A total of 151 patients' record indicated for ciprofloxacin were included in the study.", 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All ciprofloxacin included prescription during the study period.\n\nExclusion Criteria:\n\n* un included ciprofloxacin prescription.'}, 'identificationModule': {'nctId': 'NCT05916105', 'briefTitle': 'Ciprofloxacin Utilization and Adverse Events Occurrence in Community Pharmacy Setting', 'organization': {'class': 'OTHER', 'fullName': 'Damanhour University'}, 'officialTitle': 'Drug Utilization Evaluation Study of Ciprofloxacin Utilization and Adverse Events Occurrence in Community Pharmacy Setting: A Cross-Sectional Study', 'orgStudyIdInfo': {'id': 'Ciprofloxacin Utilization'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ciprofloxacin', 'description': '151 record of Ciprofloxacin', 'interventionNames': ['Drug: Ciprofloxacin Tablets']}], 'interventions': [{'name': 'Ciprofloxacin Tablets', 'type': 'DRUG', 'otherNames': ['Ciprofloxacin'], 'description': 'Ciprofloxacin antibiotic', 'armGroupLabels': ['Ciprofloxacin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Damanhūr', 'state': 'Elbehairah', 'country': 'Egypt', 'facility': 'Rehab Hussein Werida', 'geoPoint': {'lat': 27.38333, 'lon': 30.95}}], 'overallOfficials': [{'name': 'Rehab H Werida, Ass. Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Damanhour University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Damanhour University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Rehab Werida', 'investigatorAffiliation': 'Damanhour University'}}}}