Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2026-02-22 @ 7:01 AM
Study NCT ID:
NCT02005068
Status:
WITHDRAWN
Last Update Posted:
2014-08-07
First Post:
2013-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ceftaroline in the Treatment of Bone and Joint Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010019', 'term': 'Osteomyelitis'}], 'ancestors': [{'id': 'D001850', 'term': 'Bone Diseases, Infectious'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000097583', 'term': 'Ceftaroline'}, {'id': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D002511', 'term': 'Cephalosporins'}, {'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'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Failed to enroll any patients despite study modifications', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-06', 'studyFirstSubmitDate': '2013-11-21', 'studyFirstSubmitQcDate': '2013-12-03', 'lastUpdatePostDateStruct': {'date': '2014-08-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of participants with defined symptoms, signs and lab values as markers of safety and tolerance.', 'timeFrame': 'Day one through one year after completion of study drug.', 'description': 'Symptoms will be assessed daily by study team while patient is hospitalized and reviewed weekly by investigator while the patient is receiving study drug. Specific symptoms will include fever, chills, rash, nausea. diarrhea, abdominal pain, pain at the surgical/infection site, vertigo, shortness of breath, hives or other rash. A baseline physical will be performed on enrollment and repeated each week at follow up visits. Labs will checked at baseline, then daily through hospitalization and then weekly. If patient develops persistent diarrhea a stool test for C. Diff PCR (polymerase chain reaction) will be performed.'}], 'primaryOutcomes': [{'measure': 'Sustained clinical remission from the treated osteoarticular infection', 'timeFrame': '1 year after study drug completion', 'description': "Sustained clinical remission is defined by the absence of either clinical or microbiological evidence of failure at 1 year after study drug completion, in patients who complete the protocol's antibiotic regimen(s) and did not require subsequent antibiotics for their osteoarticular infection beyond the protocol prescribed regimen."}], 'secondaryOutcomes': [{'measure': 'Initial clinical success from the treated osteoarticular infection', 'timeFrame': '30 days after conclusion of study antibiotic', 'description': 'Initial clinical success will be measured by the agreement of the Infectious disease consultant and Orthopedic surgeon that the patient has had a positive response to therapy. Success will be measured by decrease of CRP (C reactive protein) by 50% from baseline if initially elevated, no evidence of drainage, sinus tract formation or infection related bone instability. Follow up cultures, if available are negative for originally isolated organism. In patients with prothetic joints no new warmth, tenderness or inflammation.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Osteoarticular infections', 'Osteomyelitis', 'Joint infections', 'MRSA (Methicillin- Resistant Staphylococcus Aureus)', 'MSSA (Methicillin- Susceptible Staphylococcus Aureus)'], 'conditions': ['Osteomyelitis', 'Joint Infections']}, 'descriptionModule': {'briefSummary': 'This is a study to evaluate the efficacy of Ceftaroline in the treatment of bone and joint infections.', 'detailedDescription': 'Study evaluates the efficacy of Ceftaroline 600mg IV every 8 hours for the treatment of acute osteomyelitis and/or infected joints.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults \\> 18 years of age with the following osteoarticular infections:\n\n 1. Infected prosthetic knee or hip (first or second episode) with 2 stage procedure planned.\n\n Criteria for infected joint:\n 1. Sinus tract which communicates with the joint\n 2. Preoperative diagnosis by diagnostic, culture positive arthrocentesis\n 3. Intraoperative diagnosis-evidence of purulence/inflammation is seen by the surgeon and/or the pathologist, and at least 2 intraoperative samples grow the same organism (only 1 needed if S. aureus) OR\n 2. Acute osteomyelitis of an extremity Criteria for acute osteomyelitis (all 4 needed)\n\n 1. Onset less than 4 weeks prior to evaluation\n 2. Radiographic (plain, MRI, TC) evidence of osteomyelitis\n 3. Positive culture from bone or blood culture with organism known to cause osteomyelitis\n 4. Orthopedic consultant must concur with diagnosis. PLUS: Positive bone/joint or blood culture for an organism known to cause osteomyelitis which is Ceftaroline susceptible\n\nExclusion criteria:\n\n1. Immunocompromised hosts:\n\n 1. AIDS/HIV patients\n 2. Cancer requiring ongoing chemotherapy or radiation therapy steroid on an ongoing basis.\n 3. Any condition requiring \\> 20 mg prednisone or equivalent\n 4. TNF (tumor necrosing factor) inhibitor use (ongoing)\n 5. Organ transplant list\n2. Diabetic foot infections\n3. Osteomyelitis in association with decubitus ulcers\n4. Vertebral osteomyelitis/spinal epidural abscess\n5. Septic bursitis\n6. Gonococcal arthritis\n7. Ceftaroline nonsusceptible organisms isolated from bone, joint or blood.\n8. Infected external fixation devices\n9. Calculated creatinine clearance \\< 50 mL/min at baseline\n10. History of severe penicillin/B lactam allergy (ID to evaluate)\n11. Intravenous drug use - lifetime exclusion\n12. Patients with a nail puncture wound to foot\n13. Patients at high risk for MDR (multidrug resistant) Gram negative organisms\n\nPlease note the use of antibiotic containing cement is not exclusion, as it represents standard of care in some of the infections to be studied'}, 'identificationModule': {'nctId': 'NCT02005068', 'briefTitle': 'Ceftaroline in the Treatment of Bone and Joint Infections', 'organization': {'class': 'OTHER', 'fullName': 'Orlando Health, Inc.'}, 'officialTitle': 'Ceftaroline in the Treatment of Bone and Joint Infections', 'orgStudyIdInfo': {'id': 'TEF-IT-17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acute Osteomyelitis - Non MRSA', 'description': 'For treatment of Acute osteomyelitis (\\< 6 months duration) Non MRSA isolate- Ceftaroline 600 MG (milligram) IV (intra-venous) every 8 hours for 6 weeks.', 'interventionNames': ['Drug: Ceftaroline']}, {'type': 'EXPERIMENTAL', 'label': 'Acute osteomyelitis MRSA isolate', 'description': 'For treatment of Acute osteomyelitis (\\< 6 months duration) MRSA isolate- Ceftaroline 600 MG IV every 8 hours for 8 weeks.', 'interventionNames': ['Drug: Ceftaroline']}, {'type': 'EXPERIMENTAL', 'label': 'Prosthetic joint infection', 'description': 'For treatment of prosthetic joint infection Ceftaroline 600 mg IV every 8 hours for 6 weeks.', 'interventionNames': ['Drug: Ceftaroline']}], 'interventions': [{'name': 'Ceftaroline', 'type': 'DRUG', 'otherNames': ['Teflaro', 'Ceftaroline fosamil', 'PPI-0903', 'TAK-599,', 'ceftaroline acetate', 'ceftaroline prodrug', 'ceftaroline fosamil for injection', 'Ceftaroline: PPI-0903M', 'T 91825', 'Chemical Name (6R,7R)-7-{(2Z)-2-(ethoxyimino)-2-[5-', '(phosphonoamino)-1,2,4-thiadiazol-3-', 'yl]acetamino}-3-[(4-(1-methylpyridin-1-ium-4-yl)-', '1,3-thiazol-2-yl]sulfanyl}-8-oxo-5-thia-1-', 'azabicyclo[4.2.0]oct-2-ene-2-carboxylate'], 'description': 'The duration of treatment will vary based on type of infection (acute osteomyelitis or joint infection) and if MRSA positive or negative.', 'armGroupLabels': ['Acute Osteomyelitis - Non MRSA', 'Acute osteomyelitis MRSA isolate', 'Prosthetic joint infection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Orlando Regional Medical Center', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}], 'overallOfficials': [{'name': 'Mark R. Wallace, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Orlando Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Orlando Health, Inc.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Forest Laboratories', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Infectious Disease Faculty Practice', 'investigatorFullName': 'Mark Wallace MD', 'investigatorAffiliation': 'Orlando Health, Inc.'}}}}