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

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

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

Study Overview

• Status: Completed
• Conditions: Gram-Positive Bacterial Infections
• Intervention / Treatment: Drug: Oritavancin

• Study Type: Observational
• Enrollment (Actual): 325

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35243
      • Birmingham Infectious Disease and Infusion
  • California
    • Santa Barbara, California, United States, 93105
      • Santa Barbara Cottage Hospital
  • Florida
    • Fort Myers, Florida, United States, 33912
      • Florida Infectious Disease Care
    • Ocala, Florida, United States, 34471
      • Infectious Diseases Associates of North Central Florida, LLC
  • Georgia
    • Marietta, Georgia, United States, 30060
      • WellStar Health System - Kennestone
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Snake River Research, PLLC
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • St. Vincent Hospital And Health Care Center, Inc.
  • Iowa
    • Council Bluffs, Iowa, United States, 51503
      • Methodist Jennie Edmundson Hospital
  • Kansas
    • Wichita, Kansas, United States, 67214
      • IDC Clinical Research, LLC
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Clinical Infectious Disease Specialists
  • New York
    • Brooklyn, New York, United States, 11215
      • New York-Presbyterian Brooklyn Methodist Hospital
    • Buffalo, New York, United States, 14215
      • Erie County Medical Center
  • North Dakota
    • Minot, North Dakota, United States, 58701
      • Trinity Health Medical Group
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73109
      • Infectious Diseases Consultants of OKC
  • Pennsylvania
    • DuBois, Pennsylvania, United States, 15801
      • TruCare Internal Medicine and Infectious Diseases
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • Texas
    • El Paso, Texas, United States, 79902
      • Center for Infectious Diseases & Travel Medicine
    • The Woodlands, Texas, United States, 77380
      • Houston Center For Infectious Diseases
    • Victoria, Texas, United States, 77901
      • Infectious Disease and Pulmonary
  • Utah
    • Saint George, Utah, United States, 84770
      • Foot & Ankle Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Oritavancin; 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; This study is an observational study. All participants were administered oritavancin prior to enrollment in this study.; Other Names: Orbactiv®

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Melinta Therapeutics, Inc.
• Investigators: Study Director: Medical Information, Global Health Science Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 12, 2017
• Primary Completion (ACTUAL): February 15, 2018
• Study Completion (ACTUAL): March 8, 2018

Study Registration Dates

• First Submitted: May 16, 2017
• First Submitted That Met QC Criteria: May 16, 2017
• First Posted (ACTUAL): May 18, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 12, 2018
• Last Update Submitted That Met QC Criteria: March 8, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Bacterial Infections; Gram-Positive Bacterial Infections; Anti-Infective Agents; Anti-Bacterial Agents; Oritavancin
• Other Study ID Numbers: MDCO-ORI-15-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No