Viewing Study NCT01152593


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Study NCT ID: NCT01152593
Status: UNKNOWN
Last Update Posted: 2010-06-29
First Post: 2010-05-31
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Effect of Intranasal Mupirocin on Rate of Staphylococcus Aureus Surgical Site Infection Following Cesarean Sections
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013530', 'term': 'Surgical Wound Infection'}, {'id': 'D013203', 'term': 'Staphylococcal Infections'}], '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'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016712', 'term': 'Mupirocin'}], 'ancestors': [{'id': 'D004852', 'term': 'Epoxy Compounds'}, {'id': 'D004988', 'term': 'Ethers, Cyclic'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-06-28', 'studyFirstSubmitDate': '2010-05-31', 'studyFirstSubmitQcDate': '2010-06-28', 'lastUpdatePostDateStruct': {'date': '2010-06-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of the incidence of surgical site infections after cesarean section', 'timeFrame': 'Four years'}]}, 'conditionsModule': {'conditions': ['Surgical Wound Infection', 'Cesarean Section', 'Staphylococcus Aureus']}, 'descriptionModule': {'briefSummary': 'The investigators believe that irradication of nose colonization of staphyloccocus aureus will reduce the incidence of surgical site infections after cesarean section.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women assigned to undergo cesarean section\n\nExclusion Criteria:\n\n* All others'}, 'identificationModule': {'nctId': 'NCT01152593', 'briefTitle': 'Effect of Intranasal Mupirocin on Rate of Staphylococcus Aureus Surgical Site Infection Following Cesarean Sections', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hillel Yaffe Medical Center'}, 'orgStudyIdInfo': {'id': 'HYMC0033-10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intranasal Mupirocin', 'interventionNames': ['Drug: Mupirocin']}], 'interventions': [{'name': 'Mupirocin', 'type': 'DRUG', 'description': 'Intranasal cream given to patient after confirmation of colonization', 'armGroupLabels': ['Intranasal Mupirocin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38100', 'city': 'Hadera', 'country': 'Israel', 'contacts': [{'name': 'Gai Shrem, MD', 'role': 'CONTACT', 'email': 'gais@hy.health.gov.il'}, {'name': 'Gai Shrem, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hillel Yaffe Medical Center', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Gai Shrem, MD', 'oldOrganization': 'Hillel Yaffe Medical Center'}}}}