Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2025-12-25 @ 8:43 PM
Study NCT ID:
NCT00737269
Status:
COMPLETED
Last Update Posted:
2013-03-04
First Post:
2008-08-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Complicated Skin and Soft-tissue Infection Patient Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D013207', 'term': 'Staphylococcal Skin Infections'}, {'id': 'D013530', 'term': 'Surgical Wound Infection'}, {'id': 'D000038', 'term': 'Abscess'}, {'id': 'D002481', 'term': 'Cellulitis'}, {'id': 'D018461', 'term': 'Soft Tissue Infections'}], 'ancestors': [{'id': 'D013203', 'term': 'Staphylococcal Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D017192', 'term': 'Skin Diseases, Bacterial'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1081}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-01', 'studyFirstSubmitDate': '2008-08-14', 'studyFirstSubmitQcDate': '2008-08-14', 'lastUpdatePostDateStruct': {'date': '2013-03-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Complicated Skin and Soft-Tissue Infection', 'Skin Infection', 'Skin Infection Registry', 'cSSTI Registry'], 'conditions': ['Staphylococcal Skin Infections', 'Diabetic Foot Infections', 'Surgical Wound Infection', 'Abscess', 'Cellulitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this registry is to better understand (1) complicated skin and soft-tissue infections requiring hospitalization, and (2) clinical and economic outcomes in hospitalized patients receiving intravenous antibiotic therapy.', 'detailedDescription': 'A prospective, multi-center, observational study involving 1200 patients hospitalized for the treatment of cSSTIs. The study will be conducted at approximately 50 hospitals in the US. Patients who consent to participate in the registry will be enrolled in the registry within 24 hours of initial IV antibiotic therapy for treatment of one or more cSSTI types. Sites will treat patients according to their usual clinical practice. The objective of this registry is to characterize cSSTIs with respect to patient characteristics and describe patient outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with complicated skin and soft tissue infections (specifically, diabetic foot infections, surgical site infections, deep soft tissue abscess, cellulitis)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a diagnosis of complicated skin and soft-tissue infection\n* Patients who require IV antibiotic therapy as a primary treatment regimen\n* Patients who are deemed to be cognitive and able to provide written informed consent and follow-up information.\n\nExclusion Criteria:\n\n* Patients with a diagnosis at the index infection site of necrotizing soft tissue infection, burn, gangrene, decubitus ulcer, animal or human bites, known or suspected osteomyelitis, or mediastinitis\n* Patients for whom amputation or a complete resection of the infection site is a planned component of treatment\n* Patients who are pregnant\n* Patients simultaneously participating in any interventional clinical trial\n* Patients with any other known or suspected condition that may jeopardize adherence to registry protocol requirements\n* Patients who are employees of the investigator or study hospital'}, 'identificationModule': {'nctId': 'NCT00737269', 'briefTitle': 'A Complicated Skin and Soft-tissue Infection Patient Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ortho-McNeil Janssen Scientific Affairs, LLC'}, 'officialTitle': 'A Prospective, Multi-center, Observational Registry Involving Patients Hospitalized With Complicated Skin and Soft Tissue Infections (cSSTI) for IV Antibiotic Therapy', 'orgStudyIdInfo': {'id': 'CR015043'}, 'secondaryIdInfos': [{'id': 'CEFTOSSK4001', 'type': 'OTHER', 'domain': 'Ortho-McNeil Janssen Scientific Affairs, LLC'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ortho-McNeil Janssen Scientific Affairs, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ortho-McNeil Janssen Scientific Affairs, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}