Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-30 @ 4:02 PM
Study NCT ID:
NCT00719056
Status:
COMPLETED
Last Update Posted:
2008-07-21
First Post:
2008-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Teicoplanin Prophylaxis for Total Hip or Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013530', 'term': 'Surgical Wound Infection'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017334', 'term': 'Teicoplanin'}, {'id': 'D006020', 'term': 'Glycopeptides'}, {'id': 'D002939', 'term': 'Ciprofloxacin'}, {'id': 'D002511', 'term': 'Cephalosporins'}], 'ancestors': [{'id': 'D000077427', 'term': 'Lipoglycopeptides'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'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'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013843', 'term': 'Thiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 616}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-07', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-07-18', 'studyFirstSubmitDate': '2008-07-14', 'studyFirstSubmitQcDate': '2008-07-18', 'lastUpdatePostDateStruct': {'date': '2008-07-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare the efficacy of single dose teicoplanin compared with comparator agents in the prevention of surgical site infections after total hip or knee arthroplasty.', 'timeFrame': 'Two years'}], 'secondaryOutcomes': [{'measure': 'To compare the efficacy of single dose teicoplanin compared with comparator agents in the separate prevention of superficial or deep surgical site infections after total hip or knee arthroplasty.', 'timeFrame': 'Two years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['teicoplanin', 'prophylaxis', 'arthroplasty', 'surgical site infections'], 'conditions': ['Total Hip and Knee Arthroplasties']}, 'referencesModule': {'references': [{'pmid': '16424973', 'type': 'BACKGROUND', 'citation': 'Soriano A, Popescu D, Garcia S, Bori G, Martinez JA, Balasso V, Marco F, Almela M, Mensa J. Usefulness of teicoplanin for preventing methicillin-resistant Staphylococcus aureus infections in orthopedic surgery. Eur J Clin Microbiol Infect Dis. 2006 Jan;25(1):35-8. doi: 10.1007/s10096-005-0073-z.'}, {'pmid': '8144419', 'type': 'BACKGROUND', 'citation': 'Wilson AP, Gruneberg RN, Neu H. Dosage recommendations for teicoplanin. J Antimicrob Chemother. 1993 Dec;32(6):792-6. doi: 10.1093/jac/32.6.792. No abstract available.'}, {'pmid': '9833102', 'type': 'BACKGROUND', 'citation': 'Nehrer S, Thalhammer F, Schwameis E, Breyer S, Kotz R. Teicoplanin in the prevention of infection in total hip replacement. Arch Orthop Trauma Surg. 1998;118(1-2):32-6. doi: 10.1007/s004020050306.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective, open-label, randomized clinical trial where patients were administered prophylaxis for total hip or knee arthroplasty either with teicoplanin or with other antibiotics. The study is aiming to evaluate any differences between these two different strategies of antimicrobial prophylaxis in the occurrence of surgical site infections', 'detailedDescription': 'This is a prospective, open-label, randomized clinical trial where patients were administered prophylaxis for total hip or knee arthroplasty either with a single dose of teicoplanin or with multiple doses of other antibiotics according to the habits of the attending physicians aiming to evaluate any differences between these two different strategies of antimicrobial prophylaxis in the occurrence of surgical site infections'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients admitted for total hip arthroplasty\n* Patients admitted for total knee arthroplasty\n\nExclusion Criteria:\n\n* Revision arthroplasty\n* History of any infection within the preceding two months\n* History of an operation in the same hip or knee for other causes\n* Known history of allergy to the studied drug\n* Pregnancy or lactation\n* Any antibiotic therapy in the week before operation.'}, 'identificationModule': {'nctId': 'NCT00719056', 'briefTitle': 'Teicoplanin Prophylaxis for Total Hip or Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'University of Athens'}, 'officialTitle': 'Efficacy of Teicoplanin for the Prevention of Surgical Site Infections After Total Hip or Knee Arthroplasty: A Prospective, Open-Label Randomized Study', 'orgStudyIdInfo': {'id': 'TEICO01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Surgical chemoprophylaxis of one dose of teicoplanin upon introduction of anesthesia for total hip or knee arthroplasty.', 'interventionNames': ['Drug: Teicoplanin']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Surgical chemoprophylaxis with multiple dose of other antimicrobials for up to six consecutive days for total hip or knee arthroplasty.', 'interventionNames': ['Drug: β-lactams or ciprofloxacin']}], 'interventions': [{'name': 'Teicoplanin', 'type': 'DRUG', 'otherNames': ['Glycopeptide'], 'description': 'The selected dose was 10mg/kg and it was given intravenously by a catheter inserted under aseptic conditions in a forearm vein within 15 minutes; it was diluted in one 5% glucose solution of a 50 ml final volume', 'armGroupLabels': ['1']}, {'name': 'β-lactams or ciprofloxacin', 'type': 'DRUG', 'otherNames': ['Cephalosporins or ciprofloxacin or penicillincs'], 'description': 'Multiple doses for up to six consecutive days', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14527', 'city': 'Marousi', 'state': 'Athens', 'country': 'Greece', 'facility': '2nd Department of Orthopedics, KAT Hospital', 'geoPoint': {'lat': 38.05, 'lon': 23.8}}, {'zip': '14527', 'city': 'Marousi', 'state': 'Athens', 'country': 'Greece', 'facility': '3rd Department of Orthopedics, KAT Hospital', 'geoPoint': {'lat': 38.05, 'lon': 23.8}}, {'zip': '14527', 'city': 'Marousi', 'state': 'Athens', 'country': 'Greece', 'facility': '4th Department of Orthopedics, KAT Hospital', 'geoPoint': {'lat': 38.05, 'lon': 23.8}}], 'overallOfficials': [{'name': 'Helen Giamarellou, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': '4th Department of Internal Medicine, University of Athens, Medical School, Greece'}, {'name': 'Amyntas Varvaroussis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '3rd Department of Orthopedics, KAT Hospital, Maroussi, Greece'}, {'name': 'Panagiotis Papadelis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '2nd Department of Orthopedics, KAT Hospital, Maroussi, Greece'}, {'name': 'Vassilios Nikolaidis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '4th Department of Orthopedics, KAT Hospital, Maroussi, Greece'}, {'name': 'Antonios Papadopoulos, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': '4th Department of Internal Medicine, University of Athens, Medical School, Greece'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Athens', 'class': 'OTHER'}, 'collaborators': [{'name': 'KAT Hospital of Athens', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldOrganization': 'University of Athens, Medical School, Greece'}}}}