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

Melinta Therapeutics, Inc.325 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

325

Conditions

Gram-Positive Bacterial Infections

Interventions

OritavancinDRUG

This study is an observational study. All participants were administered oritavancin prior to enrollment in this study.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (21)

Birmingham Infectious Disease and Infusion

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

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).

Time frame: 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.

Time frame: 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.

Time frame: Up to 30 days after oritavancin IV infusion

Duration Of Treatment With Oritavancin

The number of days of treatment with oritavancin will be presented.

Time frame: 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

Data from ClinicalTrials.gov

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