Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-01-05 @ 6:10 PM
Study NCT ID:
NCT00303550
Status:
COMPLETED
Last Update Posted:
2007-03-27
First Post:
2006-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Intravenous (I.V.) Iclaprim Versus Linezolid in Complicated Skin and Skin Structure Infections [cSSSI] (ASSIST-2)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017192', 'term': 'Skin Diseases, Bacterial'}, {'id': 'D002481', 'term': 'Cellulitis'}], 'ancestors': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'statusVerifiedDate': '2006-03', 'lastUpdateSubmitDate': '2007-03-26', 'studyFirstSubmitDate': '2006-03-15', 'studyFirstSubmitQcDate': '2006-03-15', 'lastUpdatePostDateStruct': {'date': '2007-03-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-03-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical cure rate (the ratio of number of clinically cured patients to the total number of patients in the population) at 7 to 14 days after the end of therapy'}], 'secondaryOutcomes': [{'measure': 'Microbiological eradication rate at 7-14 days after end of therapy'}, {'measure': 'Safety evaluations conducted during the study'}]}, 'conditionsModule': {'keywords': ['skin infection', 'complicated skin infection', 'skin structure infection', 'Complicated Skin and Skin Structure Infection'], 'conditions': ['Skin Diseases, Bacterial']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.arpida.ch', 'label': 'ARPIDA AG corporate website'}]}, 'descriptionModule': {'briefSummary': 'The study is now completed', 'detailedDescription': 'Primary Objective:\n\nThe primary objective of this study is to compare the clinical cure rates of iclaprim and linezolid at the test of cure (TOC) visit (7 to 14 days after the end of treatment).\n\nSecondary Objectives:\n\nThe secondary objectives of this study are to compare iclaprim with linezolid regarding:\n\n* Clinical efficacy at the end of study medication treatment;\n* Time to resolution of systemic and local signs and symptoms of complicated skin and skin structure infection (cSSSI);\n* Clinical outcome in the microbiologically evaluable (ME) population;\n* Bacteriologic outcome in the ME population;\n* Bacteriologic eradication rates of Baseline (BL) pathogens;\n* Clinical outcome in the modified intent-to-treat (MITT) population;\n* Bacteriologic outcome in the MITT population;\n* Baseline in vitro susceptibility of isolated pathogens in the ME population; and\n* Safety and tolerability of iclaprim treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of an infection consistent with complicated skin and skin structure infection due to a gram positive pathogen.\n\nExclusion Criteria:\n\n* Known or suspected hypersensitivity to any study medication or other related anti-infective medication\n* Any known or suspected condition or concurrent treatment contraindicated by the prescribing information\n* Previous enrollment in this study\n* Treatment with any investigational drug within 30 days before enrollment'}, 'identificationModule': {'nctId': 'NCT00303550', 'briefTitle': 'Study of Intravenous (I.V.) Iclaprim Versus Linezolid in Complicated Skin and Skin Structure Infections [cSSSI] (ASSIST-2)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Arpida AG'}, 'officialTitle': 'Phase 3, Randomized, Investigator-Blind, Multi-Center Study to Evaluate Efficacy and Safety of Intravenous Iclaprim Versus Linezolid in Complicated Skin and Skin Structure Infections (ASSIST-2)', 'orgStudyIdInfo': {'id': 'Protocol No. ICLA-09-CSI2'}, 'secondaryIdInfos': [{'id': 'ASSIST-2'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Intravenous iclaprim', 'type': 'DRUG'}, {'name': 'Intravenous linezolid', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60540', 'city': 'Naperville', 'state': 'Illinois', 'country': 'United States', 'facility': 'Edward Hospital & Health Services', 'geoPoint': {'lat': 41.78586, 'lon': -88.14729}}, {'zip': '82601', 'city': 'Casper', 'state': 'Wyoming', 'country': 'United States', 'facility': 'Wyoming Medical Center', 'geoPoint': {'lat': 42.86663, 'lon': -106.31308}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arpida AG', 'class': 'INDUSTRY'}}}}