Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2025-12-31 @ 2:21 PM
Study NCT ID:
NCT05223400
Status:
COMPLETED
Last Update Posted:
2023-02-03
First Post:
2022-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug Use Evaluation of Clindamycin in Critical Care Units in Alexandria Main University Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001424', 'term': 'Bacterial Infections'}], 'ancestors': [{'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002981', 'term': 'Clindamycin'}], 'ancestors': [{'id': 'D008034', 'term': 'Lincomycin'}, {'id': 'D055231', 'term': 'Lincosamides'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-02', 'studyFirstSubmitDate': '2022-01-06', 'studyFirstSubmitQcDate': '2022-02-02', 'lastUpdatePostDateStruct': {'date': '2023-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the number of prescriptions with appropriate indications of clindamycin will be counted during the retrospective observation of all prescriptions', 'timeFrame': '1 month', 'description': 'appropriateness of clindamycin indication will be determined according to IDSA guidelines.'}], 'secondaryOutcomes': [{'measure': 'the number of prescriptions with duplication of therapy with clindamycin will be counted during the retrospective observation of all prescriptions', 'timeFrame': '1 month', 'description': 'duplication of therapy means prescribing of clindamycin concurrently with another antibiotic to target the same microorganism.'}, {'measure': 'the number of patients who had diarrhea as a main side effect of clindamycin', 'timeFrame': '1 month', 'description': 'diarrhea is a main side effect of clindamycin so in the study the number of patients who had diarrhea will be counted during the retrospective observation of all prescriptions'}, {'measure': 'the number of patients who had severe drug interactions with clindamycin', 'timeFrame': '1 month', 'description': 'in the study the number of patients who severe clindamycin drugs interactions will be counted during the retrospective observation of all prescriptions'}, {'measure': 'Total clindamycin DDD defined daily doses and clindamycin defined daily doses per 1000 patients days.', 'timeFrame': '1 month', 'description': 'Defined daily doses measurement of a drug is an indicator put by WHO , it indicates the consumption of this drug in a hospital or a department and defined daily doses per 1000 patients days indicates the consumption of this drug in relation to the total number of patients in a certain period of time.'}, {'measure': 'to calculate the total cost of clindamycin.', 'timeFrame': '1 month', 'description': 'The cost of clindamycin treatment courses of all patients will be calculated in the Egyptian pound'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infection, Bacterial']}, 'descriptionModule': {'briefSummary': 'Irrational use of antibiotics is a one of the main health system problems,it leads to antibiotic resistance,increasing antibiotics side effects and the total cost. This study is a medication use evaluation study aims to evaluate intravenous clindamycin prescribing practice in critical care units in Alexandria Main University Hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All adult patients admitted to critical care units and on clindamycin emperical therapy .', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults 18 years old or more .\n* Patients on clindamycin as an empirical treatment.\n* Patients started clindamycin as an emperical treatment in other departments but the physician approved to continue it in critical care.\n\nExclusion Criteria:\n\n* Children (less than 18 years old)\n* Patients started clindamycin as a defenitive treatment (based on microbiological culture results).'}, 'identificationModule': {'nctId': 'NCT05223400', 'briefTitle': 'Drug Use Evaluation of Clindamycin in Critical Care Units in Alexandria Main University Hospital', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Drug Use Evaluation Study of Clindamycin in Critical Care Units in Alexandria Main University Hospital', 'orgStudyIdInfo': {'id': '0305292'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Clindamycin Injection', 'type': 'DRUG', 'description': 'it is a clindamycin use evaluation study'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Faculty of Mdicine', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'supervisor of clinical pharmacy unit in Alexandria Main University Hospital', 'investigatorFullName': 'Heba Shaker', 'investigatorAffiliation': 'Alexandria University'}}}}