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


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This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

The Medicines Company

ClinicalTrials.gov Identifier:

NCT03159403

First received: May 16, 2017

Last updated: May 16, 2017

Last verified: May 2017

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

Gram-Positive Bacterial Infections Drug: Oritavancin

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
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

Primary Outcome Measures:

  • Types Of Primary Infections Being Treated With Oritavancin [ Time Frame: Day 1 ]

    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).

  • Classification Of Primary Infections Being Treated With Oritavancin [ Time Frame: Day 1 ]

    The classification of primary infection refers to whether a skin or skin structure infection was cellulitis, abscess, wound, or other.

  • Proportion Of Participants With Positive Cultures For Gram Positive, Gram Negative, And Anaerobic Pathogens From The Infected Site [ Time Frame: Up to 30 days after oritavancin IV infusion ]

    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.

  • Duration Of Treatment With Oritavancin [ Time Frame: Day 1 through end of oritavancin IV infusion ]

    The number of days of treatment with oritavancin will be presented.

  • Proportion Of Participants With A Clinical Outcome Of Cure, Improved, or Failure [ Time Frame: Up to 30 days after oritavancin IV infusion ]

    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

  • Proportion Of Participants With A Microbiologic Eradication Or Microbiologic Persistence [ Time Frame: Up to 30 days after oritavancin IV infusion ]

    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

  • Use Of Concomitant Antibiotics With Oritavancin [ Time Frame: Day 1 through end of oritavancin IV infusion ]

    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.

Estimated Enrollment: 300
Actual Study Start Date: April 12, 2017
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
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

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

Other Name: Orbactiv®

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample

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.

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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03159403

Birmingham Infectious Disease and Infusion
Birmingham, Alabama, United States, 35243
Florida Infectious Disease Care
Fort Myers, Florida, United States, 33912
Snake River Research, PLLC
Idaho Falls, Idaho, United States, 83404
IDC Clinical Research, LLC
Wichita, Kansas, United States, 67214
Infectious Diseases Consultants of OKC
Oklahoma City, Oklahoma, United States, 73109
TruCare Internal Medicine and Infectious Diseases
DuBois, Pennsylvania, United States, 15801
Houston Center For Infectious Diseases
The Woodlands, Texas, United States, 77380

The Medicines Company

Study Director: Medical Information Global Health Science Center

Study Data/Documents: Package Insert  This link exits the ClinicalTrials.gov site

Identifier: ORBACTIV® (oritavancin)
ORBACTIV® (oritavancin). United States Prescribing Information. The Medicines Company; Parsippany, New Jersey. October 2016

Responsible Party: The Medicines Company
ClinicalTrials.gov Identifier: NCT03159403     History of Changes
Other Study ID Numbers: MDCO-ORI-15-05
Study First Received: May 16, 2017
Last Updated: May 16, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Infection
Communicable Diseases
Bacterial Infections
Gram-Positive Bacterial Infections
Oritavancin
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on May 18, 2017