Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2025-12-25 @ 10:22 PM
Study NCT ID:
NCT00398658
Status:
COMPLETED
Last Update Posted:
2008-10-20
First Post:
2006-11-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prophylaxis of Acute Post-Traumatic Bacterial Endophthalmitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009877', 'term': 'Endophthalmitis'}], 'ancestors': [{'id': 'D015817', 'term': 'Eye Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005839', 'term': 'Gentamicins'}, {'id': 'D002981', 'term': 'Clindamycin'}], 'ancestors': [{'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D008034', 'term': 'Lincomycin'}, {'id': 'D055231', 'term': 'Lincosamides'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-11', 'completionDateStruct': {'date': '2004-12'}, 'lastUpdateSubmitDate': '2008-10-17', 'studyFirstSubmitDate': '2006-11-13', 'studyFirstSubmitQcDate': '2006-11-13', 'lastUpdatePostDateStruct': {'date': '2008-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-14', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Endophthalmitis', 'Post-traumatic Endophthalmitis', 'Bacterial Endophthalmitis', 'Prophylaxis of Endophthalmitis', 'Intra Ocular Injection of antibiotics'], 'conditions': ['Endophthalmitis', 'Prophylaxy of Post Traumatic Endophthalmitis', 'Bacterial Endophthalmitis']}, 'referencesModule': {'references': [{'pmid': '17420365', 'type': 'DERIVED', 'citation': 'Soheilian M, Rafati N, Mohebbi MR, Yazdani S, Habibabadi HF, Feghhi M, Shahriary HA, Eslamipour J, Piri N, Peyman GA; Traumatic Endophthalmitis Trial Research Group. Prophylaxis of acute posttraumatic bacterial endophthalmitis: a multicenter, randomized clinical trial of intraocular antibiotic injection, report 2. Arch Ophthalmol. 2007 Apr;125(4):460-5. doi: 10.1001/archopht.125.4.460.'}]}, 'descriptionModule': {'briefSummary': 'Purpose: To evaluate the efficacy of combined intraocular injection of gentamycin and clindamycin in prevention of acute posttraumatic bacterial endophthalmitis (APBE) following penetrating eye injuries.\n\nDesign: Multicenter, randomized, double masked, controlled trial. Participants: Three hundred forty six eyes of 346 patients with penetrating eye injury.\n\nMethod: Following primary repair, eyes were randomized to receive a 0.1 ml intracameral or intravitreal injection of 40µg gentamycin and 45µg clindamycin (cases), versus intracameral or intravitreal injection of 0.1ml balanced saline solution (controls). All patients received standard prophylactic antibiotic therapy (systemic, subconjunctival and topical).\n\nMain outcome measures: Occurrence of endophthalmitis within two weeks after primary repair.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients with penetrating eye injuries referred to collaborating institutes for primary repair\n\nExclusion Criteria:\n\n* Absence of light perception\n* presence of endophthalmitis at the time of initial evaluation\n* total corneal opacity\n* age under 3 years\n* severe intracameral hemorrhage\n* history of intraocular surgery and presence of a corneal ulcer\n* Monocular patients\n* the better eye in simultaneous bilateral injuries'}, 'identificationModule': {'nctId': 'NCT00398658', 'briefTitle': 'Prophylaxis of Acute Post-Traumatic Bacterial Endophthalmitis', 'organization': {'class': 'OTHER', 'fullName': 'Shahid Beheshti University of Medical Sciences'}, 'orgStudyIdInfo': {'id': '8019'}}, 'armsInterventionsModule': {'interventions': [{'name': 'gentamycin and clindamycin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '16666', 'city': 'Tehran', 'state': 'Tehran Province', 'country': 'Iran', 'facility': 'Ophthalmic Research Center', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'overallOfficials': [{'name': 'Masoud Soheilian, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ophthalmic Research Center of Shaheed Beheshti Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shahid Beheshti University of Medical Sciences', 'class': 'OTHER'}}}}