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

March 8, 2018 updated by: Melinta Therapeutics, Inc.

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
325

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35243
        • Birmingham Infectious Disease and Infusion
    • California
      • Santa Barbara, California, United States, 93105
        • Santa Barbara Cottage Hospital
    • Florida
      • Fort Myers, Florida, United States, 33912
        • Florida Infectious Disease Care
      • Ocala, Florida, United States, 34471
        • Infectious Diseases Associates of North Central Florida, LLC
    • Georgia
      • Marietta, Georgia, United States, 30060
        • WellStar Health System - Kennestone
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Snake River Research, PLLC
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • St. Vincent Hospital And Health Care Center, Inc.
    • Iowa
      • Council Bluffs, Iowa, United States, 51503
        • Methodist Jennie Edmundson Hospital
    • Kansas
      • Wichita, Kansas, United States, 67214
        • IDC Clinical Research, LLC
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Clinical Infectious Disease Specialists
    • New York
      • Brooklyn, New York, United States, 11215
        • New York-Presbyterian Brooklyn Methodist Hospital
      • Buffalo, New York, United States, 14215
        • Erie County Medical Center
    • North Dakota
      • Minot, North Dakota, United States, 58701
        • Trinity Health Medical Group
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73109
        • Infectious Diseases Consultants of OKC
    • Pennsylvania
      • DuBois, Pennsylvania, United States, 15801
        • TruCare Internal Medicine and Infectious Diseases
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center
    • Texas
      • El Paso, Texas, United States, 79902
        • Center for Infectious Diseases & Travel Medicine
      • The Woodlands, Texas, United States, 77380
        • Houston Center For Infectious Diseases
      • Victoria, Texas, United States, 77901
        • Infectious Disease and Pulmonary
    • Utah
      • Saint George, Utah, United States, 84770
        • Foot & Ankle Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • Orbactiv®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Day 1
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.
Day 1
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.
Up to 30 days after oritavancin IV infusion
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.
Day 1 through end of oritavancin IV infusion
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
Up to 30 days after oritavancin IV infusion
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
Up to 30 days after oritavancin IV infusion
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.
Day 1 through end of oritavancin IV infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Melinta Therapeutics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Information, Global Health Science Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 12, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 15, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 8, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 16, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 18, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 12, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MDCO-ORI-15-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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