Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2026-01-25 @ 8:52 AM
Study NCT ID:
NCT03159403
Status:
COMPLETED
Last Update Posted:
2018-03-12
First Post:
2017-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Retrospective Observational Study to Evaluate the Utilization, Outcomes, and Adverse Events in Participants Treated With Orbactiv® (Oritavancin) for Infections Caused by Gram Positive Bacteria in a Real World Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}], 'ancestors': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C100708', 'term': 'oritavancin'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 325}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-03-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-08', 'studyFirstSubmitDate': '2017-05-16', 'studyFirstSubmitQcDate': '2017-05-16', 'lastUpdatePostDateStruct': {'date': '2018-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Types Of Primary Infections Being Treated With Oritavancin', 'timeFrame': 'Day 1', 'description': 'The Types Of Primary Infections refers to whether the primary infection was skin or skin structure or other systemic infection (for example, bacteremia, prosthetic joint infection, osteomyelitis).'}, {'measure': 'Classification Of Primary Infections Being Treated With Oritavancin', 'timeFrame': 'Day 1', 'description': 'The classification of primary infection refers to whether a skin or skin structure infection was cellulitis, abscess, wound, or other.'}, {'measure': 'Proportion Of Participants With Positive Cultures For Gram Positive, Gram Negative, And Anaerobic Pathogens From The Infected Site', 'timeFrame': 'Up to 30 days after oritavancin IV infusion', 'description': 'All microbiology results during the infection event will be reported. Microbiology results will be noted only for the infection site for which oritavancin (in addition to other agents) is administered or other site related to the primary infection in case of multiple infections. An adverse event was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship.'}, {'measure': 'Duration Of Treatment With Oritavancin', 'timeFrame': 'Day 1 through end of oritavancin IV infusion', 'description': 'The number of days of treatment with oritavancin will be presented.'}, {'measure': 'Proportion Of Participants With A Clinical Outcome Of Cure, Improved, or Failure', 'timeFrame': 'Up to 30 days after oritavancin IV infusion', 'description': 'Clinical assessments will be based on participant records between end of infusion to 30 days following the last dose of Oritavancin. Clinical categories for assessment include:\n\n* Cure - Clinical signs and symptoms are resolved, and no additional antibiotic therapy is necessary for the treatment of the infection\n* Improved - Partial resolution of clinical signs and symptoms, and no additional antibiotic therapy is necessary for the treatment of the infection\n* Failure - Inadequate resolution, or new or worsening clinical signs and symptoms, such that additional antibiotic therapy is necessary for treatment of the infection\n* Non-evaluable - Unable to determine response because the participant record did not contain the necessary information to determine cure, improvement, or failure'}, {'measure': 'Proportion Of Participants With A Microbiologic Eradication Or Microbiologic Persistence', 'timeFrame': 'Up to 30 days after oritavancin IV infusion', 'description': 'Microbiological assessments will be based on participant records between end of infusion to 30 days following the last dose of oritavancin. Microbiological categories will include only gram positive pathogens believed to be related to the infection process and are defined as:\n\n* Microbiologic eradication (the baseline gram positive pathogen has been eradicated)\n* Microbiologic persistence (the baseline gram positive pathogen persists)\n* Culture drawn post-oritavancin therapy, but no information regarding microbiologic culture results\n* No culture collected following the last dose of oritavancin\n* No information available'}, {'measure': 'Use Of Concomitant Antibiotics With Oritavancin', 'timeFrame': 'Day 1 through end of oritavancin IV infusion', 'description': 'Concomitant antibiotics include those used between the first and last dose of oritavancin. The number of participants and the type of antibiotic taken will be presented.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gram-Positive Bacterial Infections']}, 'descriptionModule': {'briefSummary': 'This study is a retrospective, observational study to evaluate oritavancin use in participants under real world conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Participants in real world settings (which include infusion centers, clinics, emergency departments, and observation and inpatient hospital beds), who received at least one dose of oritavancin.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The participant was treated with at least one dose of oritavancin for a suspected or confirmed gram positive infection, as monotherapy or part of a broader regimen.\n* At least 60 days has elapsed since the participant received the last dose of oritavancin therapy (prior to data entry into the electronic Case Report Form).\n\nExclusion Criteria:\n\n* The participant received oritavancin as a part of a controlled clinical trial.\n* The participant received oritavancin as a part of a Medicines Company-sponsored single or multi-centered pharmacoeconomic outcomes study.'}, 'identificationModule': {'nctId': 'NCT03159403', 'briefTitle': 'A Retrospective Observational Study to Evaluate the Utilization, Outcomes, and Adverse Events in Participants Treated With Orbactiv® (Oritavancin) for Infections Caused by Gram Positive Bacteria in a Real World Setting', 'organization': {'class': 'INDUSTRY', 'fullName': 'Melinta Therapeutics, Inc.'}, 'officialTitle': 'Retrospective, Observational Evaluation of the Utilization, Outcomes, and Adverse Events Associated With Orbactiv® for the Treatment of Infections Presumed or Confirmed to be Caused by Gram Positive Bacteria in a Real World Setting', 'orgStudyIdInfo': {'id': 'MDCO-ORI-15-05'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Oritavancin', 'description': 'Participants who received at least one dose (at least one for 3 hours per dose) of oritavancin intravenous (IV) as monotherapy or part of a broader regimen. The maximum number of doses to be received by a participant is not known at this time.', 'interventionNames': ['Drug: Oritavancin']}], 'interventions': [{'name': 'Oritavancin', 'type': 'DRUG', 'otherNames': ['Orbactiv®'], 'description': 'This study is an observational study. All participants were administered oritavancin prior to enrollment in this study.', 'armGroupLabels': ['Oritavancin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35243', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Birmingham Infectious Disease and Infusion', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '93105', 'city': 'Santa Barbara', 'state': 'California', 'country': 'United States', 'facility': 'Santa Barbara Cottage Hospital', 'geoPoint': {'lat': 34.42083, 'lon': -119.69819}}, {'zip': '33912', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Infectious Disease Care', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '34471', 'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'facility': 'Infectious Diseases Associates of North Central Florida, LLC', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'WellStar Health System - Kennestone', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '83404', 'city': 'Idaho Falls', 'state': 'Idaho', 'country': 'United States', 'facility': 'Snake River Research, PLLC', 'geoPoint': {'lat': 43.46658, 'lon': -112.03414}}, {'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'St. Vincent Hospital and Health Care Center, Inc.', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '51503', 'city': 'Council Bluffs', 'state': 'Iowa', 'country': 'United States', 'facility': 'Methodist Jennie Edmundson Hospital', 'geoPoint': {'lat': 41.26194, 'lon': -95.86083}}, {'zip': '67214', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'IDC Clinical Research, LLC', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '89128', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Clinical Infectious Disease Specialists', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '11215', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'New York-Presbyterian Brooklyn Methodist Hospital', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '14215', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Erie County Medical Center', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '58701', 'city': 'Minot', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Trinity Health Medical Group', 'geoPoint': {'lat': 48.23251, 'lon': -101.29627}}, {'zip': '73109', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Infectious Diseases Consultants of OKC', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '15801', 'city': 'DuBois', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'TruCare Internal Medicine and Infectious Diseases', 'geoPoint': {'lat': 41.11923, 'lon': -78.76003}}, {'zip': '15212', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Allegheny General Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '79902', 'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'facility': 'Center for Infectious Diseases & Travel Medicine', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}, {'zip': '77380', 'city': 'The Woodlands', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Center For Infectious Diseases', 'geoPoint': {'lat': 30.15799, 'lon': -95.48938}}, {'zip': '77901', 'city': 'Victoria', 'state': 'Texas', 'country': 'United States', 'facility': 'Infectious Disease and Pulmonary', 'geoPoint': {'lat': 28.80527, 'lon': -97.0036}}, {'zip': '84770', 'city': 'St. George', 'state': 'Utah', 'country': 'United States', 'facility': 'Foot & Ankle Institute', 'geoPoint': {'lat': 37.10415, 'lon': -113.58412}}], 'overallOfficials': [{'name': 'Medical Information', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Global Health Science Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Melinta Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}