Clinical trial NCT03159403: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gram-Positive Bacterial Infections
Lead sponsor: Melinta Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2017-05-18
Enrollment: 325
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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


Eligibility criteria: 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.

Primary outcomes:
measure: Types Of Primary Infections Being Treated With Oritavancin
timeFrame: Day 1
measure: Classification Of Primary Infections Being Treated With Oritavancin
timeFrame: Day 1
measure: Proportion Of Participants With Positive Cultures For Gram Positive, Gram Negative, And Anaerobic Pathogens From The Infected Site
timeFrame: Up to 30 days after oritavancin IV infusion
measure: Duration Of Treatment With Oritavancin
timeFrame: Day 1 through end of oritavancin IV infusion
measure: Proportion Of Participants With A Clinical Outcome Of Cure, Improved, or Failure
timeFrame: Up to 30 days after oritavancin IV infusion
measure: Proportion Of Participants With A Microbiologic Eradication Or Microbiologic Persistence
timeFrame: Up to 30 days after oritavancin IV infusion
measure: Use Of Concomitant Antibiotics With Oritavancin
timeFrame: Day 1 through end of oritavancin IV infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Infectious Disease and Infusion
state: Alabama
city: Santa Barbara
country: United States
facility: Santa Barbara Cottage Hospital
state: California
city: Fort Myers
country: United States
facility: Florida Infectious Disease Care
state: Florida
city: Ocala
country: United States
facility: Infectious Diseases Associates of North Central Florida, LLC
state: Florida
city: Marietta
country: United States
facility: WellStar Health System - Kennestone
state: Georgia
city: Idaho Falls
country: United States
facility: Snake River Research, PLLC
state: Idaho
city: Indianapolis
country: United States
facility: St. Vincent Hospital and Health Care Center, Inc.
state: Indiana
city: Council Bluffs
country: United States
facility: Methodist Jennie Edmundson Hospital
state: Iowa
city: Wichita
country: United States
facility: IDC Clinical Research, LLC
state: Kansas
city: Las Vegas
country: United States
facility: Clinical Infectious Disease Specialists
state: Nevada
city: Brooklyn
country: United States
facility: New York-Presbyterian Brooklyn Methodist Hospital
state: New York
city: Buffalo
country: United States
facility: Erie County Medical Center
state: New York
city: Minot
country: United States
facility: Trinity Health Medical Group
state: North Dakota
city: Oklahoma City
country: United States
facility: Infectious Diseases Consultants of OKC
state: Oklahoma
city: DuBois
country: United States
facility: TruCare Internal Medicine and Infectious Diseases
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: El Paso
country: United States
facility: Center for Infectious Diseases & Travel Medicine
state: Texas
city: The Woodlands
country: United States
facility: Houston Center For Infectious Diseases
state: Texas
city: Victoria
country: United States
facility: Infectious Disease and Pulmonary
state: Texas
city: Saint George
country: United States
facility: Foot & Ankle Institute
state: Utah
Study officials:
affiliation: Global Health Science Center
name: Medical Information
role: STUDY_DIRECTOR
References: