Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2025-12-31 @ 2:26 PM
Study NCT ID:
NCT04020406
Status:
COMPLETED
Last Update Posted:
2019-07-16
First Post:
2019-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antibacterial Activity of Urea Against Ocular Bacteria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014511', 'term': 'Uremia'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-11', 'studyFirstSubmitDate': '2019-07-07', 'studyFirstSubmitQcDate': '2019-07-11', 'lastUpdatePostDateStruct': {'date': '2019-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antibacterial effect of Urea Solution against Ocular Bacterial', 'timeFrame': '6 month', 'description': "Samples were both inoculated on Muller Agar (Sigma-Aldrich) plates and directly examined under the microscope using Gram stained smears. Inoculated plates were incubated at 37oC for 48 hrs.\n\nGram negative isolates were sub-cultured on MacConkey's, Eosin Methelyene Blue (EMB) and Cystine Lactose Electrolyte Deficient (CLED) agar plates (Sigma-Aldrich). Gram positive isolates were sub-cultured on Mannitol Salt agar plates (Sigma-Aldrich)."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Urea in Blood; High']}, 'descriptionModule': {'briefSummary': 'Antibacterial properties of urea was tested against 35 isolates from ocular infections.', 'detailedDescription': 'In vitro susceptibility testing was performed with commercially available antibiotic discs, homemade urea discs saturated with urea solution at a concentration of 96 mmol. The weight of urea in one drop = 0.37 mg, in one ml = 10.34 mg (5 microliter/ disc) discs and combined discs (antibiotic discs to which urea solution was added). Combined discs provided better in vitro susceptibility results than antibiotics alone.\n\nScanning electron micrographs of bacterial isolates incubated overnight with urea solution showed marked disruption of bacterial aggregative patterns and irregularities of their cell walls.\n\nWestern blotting showed marked reduction in total proteins in bacterial isolates incubated overnight with urea solution. These findings may explain the possible mechanisms for antibacterial activity of urea solution as a result of protein denaturation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '5 Months', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'individuals with any ocular infection', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ocular infection\n\nExclusion Criteria:\n\n* Local antibiotics treatment'}, 'identificationModule': {'nctId': 'NCT04020406', 'briefTitle': 'Antibacterial Activity of Urea Against Ocular Bacteria', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'In Vitro Evaluation of Antibacterial Activity of Urea Solution Against Ocular Bacterial Isolates', 'orgStudyIdInfo': {'id': '2323297'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Antibacterial Activity of Urea', 'description': 'Activity of Urea Solution against Ocular Bacterial Isolates', 'interventionNames': ['Biological: Antibacterial Activity']}], 'interventions': [{'name': 'Antibacterial Activity', 'type': 'BIOLOGICAL', 'description': 'Antibacterial Activity of Urea Solution against Ocular Bacterial Isolates', 'armGroupLabels': ['Antibacterial Activity of Urea']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'Hassan Lotfy Fahmy', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'Hassan 58 Lotfy, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut T'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Hassan Lotfy Fahmy', 'investigatorAffiliation': 'Assiut University'}}}}