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

Study Overview
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Brief Summary
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This study is a retrospective, observational study to evaluate oritavancin use in participants under real world conditions.

Official Title
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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

Conditions
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Gram-Positive Bacterial Infections

Intervention / Treatment
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* Drug: Oritavancin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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). Exclusion Criteria: The participant received oritavancin as a part of a controlled clinical trial. The participant received oritavancin as a part of a Medicines Company-sponsored single or multi-centered pharmacoeconomic outcomes study.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Oritavancin<br>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. | Drug: Oritavancin<br>* This study is an observational study. All participants were administered oritavancin prior to enrollment in this study.<br>* Other names: Orbactiv®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Types Of Primary Infections Being Treated With Oritavancin | 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). | Day 1 | 
| Classification Of Primary Infections Being Treated With Oritavancin | The classification of primary infection refers to whether a skin or skin structure infection was cellulitis, abscess, wound, or other. | Day 1 | 
| Proportion Of Participants With Positive Cultures For Gram Positive, Gram Negative, And Anaerobic Pathogens From The Infected Site | 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. | Up to 30 days after oritavancin IV infusion | 
| Duration Of Treatment With Oritavancin | The number of days of treatment with oritavancin will be presented. | Day 1 through end of oritavancin IV infusion | 
| Proportion Of Participants With A Clinical Outcome Of Cure, Improved, or Failure | 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: Cure - Clinical signs and symptoms are resolved, and no additional antibiotic therapy is necessary for the treatment of the infection Improved - Partial resolution of clinical signs and symptoms, and no additional antibiotic therapy is necessary for the treatment of the infection Failure - Inadequate resolution, or new or worsening clinical signs and symptoms, such that additional antibiotic therapy is necessary for treatment of the infection Non-evaluable - Unable to determine response because the participant record did not contain the necessary information to determine cure, improvement, or failure | Up to 30 days after oritavancin IV infusion | 
| Proportion Of Participants With A Microbiologic Eradication Or Microbiologic Persistence | 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: Microbiologic eradication (the baseline gram positive pathogen has been eradicated) Microbiologic persistence (the baseline gram positive pathogen persists) Culture drawn post-oritavancin therapy, but no information regarding microbiologic culture results No culture collected following the last dose of oritavancin No information available | Up to 30 days after oritavancin IV infusion | 
| Use Of Concomitant Antibiotics With Oritavancin | 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. | Day 1 through end of oritavancin IV infusion |