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

NCT03159403 | Completed FDA Drug

• 1 other identifier: MDCO-ORI-15-05
• Study Type: observational
• Target: 325
• Locations: 1 country
• Sites: 21

Brief Summary

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

Conditions

Gram-Positive Bacterial Infections

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (1)

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

Interventions

Oritavancin DRUG

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

Also known as: Orbactiv®

Oritavancin

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Melinta Therapeutics, Inc.: lead

Study Sites (21)

Birmingham Infectious Disease and Infusion

Birmingham, Alabama, 35243, United States

Location

Santa Barbara Cottage Hospital

Santa Barbara, California, 93105, United States

Location

Florida Infectious Disease Care

Fort Myers, Florida, 33912, United States

Location

Infectious Diseases Associates of North Central Florida, LLC

Ocala, Florida, 34471, United States

Location

WellStar Health System - Kennestone

Marietta, Georgia, 30060, United States

Location

Snake River Research, PLLC

Idaho Falls, Idaho, 83404, United States

Location

St. Vincent Hospital and Health Care Center, Inc.

Indianapolis, Indiana, 46260, United States

Location

Methodist Jennie Edmundson Hospital

Council Bluffs, Iowa, 51503, United States

Location

IDC Clinical Research, LLC

Wichita, Kansas, 67214, United States

Location

Clinical Infectious Disease Specialists

Las Vegas, Nevada, 89128, United States

Location

New York-Presbyterian Brooklyn Methodist Hospital

Brooklyn, New York, 11215, United States

Location

Erie County Medical Center

Buffalo, New York, 14215, United States

Location

Trinity Health Medical Group

Minot, North Dakota, 58701, United States

Location

Infectious Diseases Consultants of OKC

Oklahoma City, Oklahoma, 73109, United States

Location

TruCare Internal Medicine and Infectious Diseases

DuBois, Pennsylvania, 15801, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Center for Infectious Diseases & Travel Medicine

El Paso, Texas, 79902, United States

Location

Houston Center For Infectious Diseases

The Woodlands, Texas, 77380, United States

Location

Infectious Disease and Pulmonary

Victoria, Texas, 77901, United States

Location

Foot & Ankle Institute

St. George, Utah, 84770, United States

Location

MeSH Terms

Conditions

Gram-Positive Bacterial Infections

Interventions

oritavancin

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Medical Information

  Global Health Science Center

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: May 18, 2017
• Study Start: April 12, 2017
• Primary Completion: February 15, 2018
• Study Completion: March 8, 2018
• Last Updated: March 12, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (21)