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

Gram-Positive Bacterial Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03159403
• Other study ID #: MDCO-ORI-15-05
• Status: Completed
• Phase: N/A
• First received: May 16, 2017
• Last updated: March 8, 2018
• Start date: April 12, 2017
• Est. completion date: March 8, 2018

Study information

• Verified date: March 2018
• Source: Melinta Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 325
• Est. completion date: March 8, 2018
• Est. primary completion date: February 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Gram-Positive Bacterial Infections
• Infection

Intervention

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

Locations

Country	Name	City	State
United States	Birmingham Infectious Disease and Infusion	Birmingham	Alabama
United States	New York-Presbyterian Brooklyn Methodist Hospital	Brooklyn	New York
United States	Erie County Medical Center	Buffalo	New York
United States	Methodist Jennie Edmundson Hospital	Council Bluffs	Iowa
United States	TruCare Internal Medicine and Infectious Diseases	DuBois	Pennsylvania
United States	Center for Infectious Diseases & Travel Medicine	El Paso	Texas
United States	Florida Infectious Disease Care	Fort Myers	Florida
United States	Snake River Research, PLLC	Idaho Falls	Idaho
United States	St. Vincent Hospital and Health Care Center, Inc.	Indianapolis	Indiana
United States	Clinical Infectious Disease Specialists	Las Vegas	Nevada
United States	WellStar Health System - Kennestone	Marietta	Georgia
United States	Trinity Health Medical Group	Minot	North Dakota
United States	Infectious Diseases Associates of North Central Florida, LLC	Ocala	Florida
United States	Infectious Diseases Consultants of OKC	Oklahoma City	Oklahoma
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Foot & Ankle Institute	Saint George	Utah
United States	Santa Barbara Cottage Hospital	Santa Barbara	California
United States	Houston Center For Infectious Diseases	The Woodlands	Texas
United States	Infectious Disease and Pulmonary	Victoria	Texas
United States	IDC Clinical Research, LLC	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Melinta Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Duration Of Treatment With Oritavancin	The number of days of treatment with oritavancin will be presented.	Day 1 through end of oritavancin IV infusion
Primary	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
Primary	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
Primary	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