This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
The Medicines Company
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 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|
- 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.
|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)|
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.
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.
- 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).
- 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.
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|
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:
Gram-Positive Bacterial Infections
ClinicalTrials.gov processed this record on May 18, 2017