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

NCT ID: NCT03159403

Last Updated: 2018-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

325 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-12

Study Completion Date

2018-03-08

Brief Summary

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

Detailed Description

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Conditions

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Gram-Positive Bacterial Infections

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Oritavancin

Intervention Type DRUG

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

Interventions

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Oritavancin

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

Intervention Type DRUG

Other Intervention Names

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Orbactiv®

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Melinta Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Information

Role: STUDY_DIRECTOR

Global Health Science Center

Locations

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Birmingham Infectious Disease and Infusion

Birmingham, Alabama, United States

Site Status

Santa Barbara Cottage Hospital

Santa Barbara, California, United States

Site Status

Florida Infectious Disease Care

Fort Myers, Florida, United States

Site Status

Infectious Diseases Associates of North Central Florida, LLC

Ocala, Florida, United States

Site Status

WellStar Health System - Kennestone

Marietta, Georgia, United States

Site Status

Snake River Research, PLLC

Idaho Falls, Idaho, United States

Site Status

St. Vincent Hospital and Health Care Center, Inc.

Indianapolis, Indiana, United States

Site Status

Methodist Jennie Edmundson Hospital

Council Bluffs, Iowa, United States

Site Status

IDC Clinical Research, LLC

Wichita, Kansas, United States

Site Status

Clinical Infectious Disease Specialists

Las Vegas, Nevada, United States

Site Status

New York-Presbyterian Brooklyn Methodist Hospital

Brooklyn, New York, United States

Site Status

Erie County Medical Center

Buffalo, New York, United States

Site Status

Trinity Health Medical Group

Minot, North Dakota, United States

Site Status

Infectious Diseases Consultants of OKC

Oklahoma City, Oklahoma, United States

Site Status

TruCare Internal Medicine and Infectious Diseases

DuBois, Pennsylvania, United States

Site Status

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Site Status

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

Center for Infectious Diseases & Travel Medicine

El Paso, Texas, United States

Site Status

Houston Center For Infectious Diseases

The Woodlands, Texas, United States

Site Status

Infectious Disease and Pulmonary

Victoria, Texas, United States

Site Status

Foot & Ankle Institute

St. George, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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MDCO-ORI-15-05

Identifier Type: -

Identifier Source: org_study_id

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