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

Completed

• Conditions: Gram-Positive Bacterial Infections
• Interventions: Drug: Oritavancin

• Registration Number: NCT03159403
• Lead Sponsor: Melinta Therapeutics, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-12
• Study First Submitted: 2017-05-16
• Study First Submitted QC: 2017-05-16
• Study First Posted: 2017-05-18
• Primary Completion: 2018-02-15
• Status Verified: 2018-03
• Study Completion: 2018-03-08
• Last Update Submitted: 2018-03-08
• Last Update Posted: 2018-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 325

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Oritavancin	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.

Primary Outcome Measures

Name	Time	Method
Types Of Primary Infections Being Treated With Oritavancin	Day 1	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).
Classification Of Primary Infections Being Treated With Oritavancin	Day 1	The classification of primary infection refers to whether a skin or skin structure infection was cellulitis, abscess, wound, or other.
Proportion Of Participants With Positive Cultures For Gram Positive, Gram Negative, And Anaerobic Pathogens From The Infected Site	Up to 30 days after oritavancin IV infusion	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.
Duration Of Treatment With Oritavancin	Day 1 through end of oritavancin IV infusion	The number of days of treatment with oritavancin will be presented.
Proportion Of Participants With A Clinical Outcome Of Cure, Improved, or Failure	Up to 30 days after oritavancin IV infusion	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
Proportion Of Participants With A Microbiologic Eradication Or Microbiologic Persistence	Up to 30 days after oritavancin IV infusion	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
Use Of Concomitant Antibiotics With Oritavancin	Day 1 through end of oritavancin IV infusion	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.

Trial Locations

Locations (21)

Birmingham Infectious Disease and Infusion; 🇺🇸 Birmingham, Alabama, United States

Santa Barbara Cottage Hospital; 🇺🇸 Santa Barbara, California, United States

Florida Infectious Disease Care; 🇺🇸 Fort Myers, Florida, United States

Infectious Diseases Associates of North Central Florida, LLC; 🇺🇸 Ocala, Florida, United States

WellStar Health System - Kennestone; 🇺🇸 Marietta, Georgia, United States

Snake River Research, PLLC; 🇺🇸 Idaho Falls, Idaho, United States

St. Vincent Hospital and Health Care Center, Inc.; 🇺🇸 Indianapolis, Indiana, United States

Methodist Jennie Edmundson Hospital; 🇺🇸 Council Bluffs, Iowa, United States

IDC Clinical Research, LLC; 🇺🇸 Wichita, Kansas, United States

Clinical Infectious Disease Specialists; 🇺🇸 Las Vegas, Nevada, United States

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