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

Status: Completed

Conditions: Gram-Positive Bacterial Infections

Treatments: Drug: Oritavancin

Study type: Observational

Funder types: Industry

Identifiers

NCT03159403

MDCO-ORI-15-05

Details and patient eligibility

About

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

Enrollment: 325 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

325 participants in 1 patient group

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.

Treatment:

Drug: Oritavancin