Oritavancin for Treatment of Serious Cardiac Infections (OSCAR)

April 23, 2026 updated by: Kirby Institute

A Multicentre Phase II Prospective Pilot Study of Pharmacokinetic- and TDM-guided Oritavancin Dosing Strategies for the Management of Gram-positive Cardiac Infections (the OSCAR Study)

Cardiac infections, including infective endocarditis and cardiovascular implantable electronic device infections, are associated with substantial morbidity and mortality and are commonly caused by gram-positive bacteria. Standard management typically requires prolonged courses of intravenous antibiotics and extended hospitalisation, which are costly, burdensome, and associated with complications related to long-term vascular access. People who inject drugs are disproportionately affected and often experience stigma, barriers to care, and poorer outcomes. Long-acting lipoglycopeptides such as oritavancin maintain therapeutic serum concentrations for prolonged periods and may offer an alternative to conventional intravenous antibiotic regimens. Oritavancin is not TGA-registered in Australia and is accessed as an unregistered medicine (for example, via SAS or clinical trials). It is approved in other jurisdictions, including the United States and European Union, for acute bacterial skin and skin structure infections. Prospective data in cardiac infections remain limited, and optimal dosing strategies, including the role of therapeutic drug monitoring, are uncertain. This multicentre, open-label pilot study will assess the feasibility, pharmacokinetics, safety, acceptability, and preliminary efficacy of oritavancin for gram-positive cardiac infections using both standard fixed dosing and TDM-guided dosing strategies. Findings will inform PK/PD modelling, the potential role of TDM, and the design of future larger-scale trials and models of care, including alternatives to prolonged inpatient intravenous therapy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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.
Interventional

Enrollment (Estimated)

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.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
      • Sydney, New South Wales, Australia, 2010
        • St Vincent's Hospital
        • Principal Investigator:
          • David Goodman
      • Sydney, New South Wales, Australia, 2031
        • Prince of Wales Hospital
        • Principal Investigator:
          • Marianne Martinello

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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥18 years
  2. Hospitalised for management of a cardiac infection (infective endocarditis or cardiovascular implantable electronic device infections)
  3. Gram-positive organism identified in blood or tissue culture, that in the opinion of the investigator is the cause of cardiac infection and would be treatable with a finite antibiotic duration (e.g., 4-6 weeks)
  4. Afebrile for at least 24 hours at screening
  5. Clearance of blood cultures for at least 24 hours at screening
  6. Receiving effective antibiotic therapy for at least 24 hours and no more than 14 days at screening
  7. Willingness of both treating provider and participant to proceed with oritavancin therapy
  8. Able to provide written informed consent
  9. Willingness and ability to participate in study procedures, including follow-up visits and drug monitoring

Exclusion Criteria:

  1. History of severe allergic reaction or hypersensitivity to oritavancin or any of its components
  2. Severe renal impairment (eGFR < 30 mL/min/1.73 m²) or currently receiving dialysis
  3. Severe hepatic impairment (Child-Pugh class C)
  4. Current infection involving the central nervous system, including septic emboli, ischemic or haemorrhagic stroke, epidural abscess, or meningitis (excluding prior/unrelated central nervous system events).
  5. Presence of prosthetic heart valve
  6. Culture negative endocarditis
  7. Presence of any other active infection requiring concurrent antibiotic treatment that could interfere with study outcomes
  8. Infection with Gram positive organism not susceptible to oritavancin or vancomycin (vancomycin MIC > 2 μg/mL).
  9. Use of contraindicated medications (see Section 8)
  10. Participation in another interventional clinical trial that may confound study outcomes
  11. Pregnant or breastfeeding people, or those planning to become pregnant during the study period (people of childbearing potential must have a negative pregnancy test during hospitalization and use effective contraception for trial duration and for 3 months after last infusion of study medication).
  12. Immunosuppression (defined as active chemotherapy expected to cause absolute neutrophil count <100 cells/mm3 lasting >7 days during the study period, bone marrow transplantation in the preceding 90 days, solid organ transplantation within prior 3 months or receipt of augmented immunosuppression for rejection within 3 months, chronic granulomatous disease, HIV with a CD4 count <50 cells/mm3 based on last known measure).
  13. Any condition (e.g. severe cognitive impairment, psychiatric illness, active withdrawal) that, in the opinion of the investigator, would limit the participant's ability to comply with study procedures or give informed consent
  14. Medically unstable in opinion of treating clinician that would preclude participation
  15. Cases in which the investigator deem curative or finite antibiotic treatment unlikely (e.g., long term indefinite suppressive antibiotics are likely such as retained hardware).

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

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Experimental: Cohort A1: Oritavancin, guideline-based dosing
Participants will receive oritavancin intravenously using a fixed weekly dosing schedule consistent with contemporary guideline-based practice. Intensive pharmacokinetic sampling will be performed to develop a population pharmacokinetic model
Drug: Oritavancin
Oritavancin administered by intravenous infusion using a fixed weekly dosing schedule consistent with the protocol-defined guideline-based regimen (1.2 g IV once weekly)
Drug: Oritavancin
Participants will receive an initial oritavancin dose (e.g. 1.2 g IV), with subsequent dosing intervals and/or additional doses informed by pre-specified TDM algorithms and individual PK estimates derived from the population model developed in Group B1.
Experimental: Cohort A2: Oritavancin (TDM-guided dosing)
Participants will receive oritavancin intravenously with subsequent dosing intervals and/or additional doses guided by therapeutic drug monitoring and individual pharmacokinetic estimates derived from the population pharmacokinetic model developed in Cohort A1
Drug: Oritavancin
Oritavancin administered by intravenous infusion using a fixed weekly dosing schedule consistent with the protocol-defined guideline-based regimen (1.2 g IV once weekly)
Drug: Oritavancin
Participants will receive an initial oritavancin dose (e.g. 1.2 g IV), with subsequent dosing intervals and/or additional doses informed by pre-specified TDM algorithms and individual PK estimates derived from the population model developed in Group B1.

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
Desirability of Outcome Ranking (DOOR) at Day 70
Time Frame: Day 70 post-enrolment

Composite ordinal outcome adapted for Gram-positive cardiac infections. Participants will be ranked from most to least desirable outcome as follows:

  1. = alive with no clinical failure, infectious complication, or serious adverse event/adverse event leading to study drug discontinuation;
  2. = alive with 1 of these events;
  3. = alive with 2 of these events;
  4. = alive with all 3 of these events;
  5. = death. Within each rank, ties will be resolved using net change in EQ-5D score from baseline to Day 70, with greater improvement indicating a more desirable outcome.
Day 70 post-enrolment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total oritavancin plasma concentration at scheduled sampling time points
Time Frame: From post-dose Day 1 through Day 70 post-enrolment
Observed total oritavancin plasma concentrations measured at protocol-specified sampling time points to support development of the population pharmacokinetic model.
From post-dose Day 1 through Day 70 post-enrolment
Oritavancin dosing interval achieved in the therapeutic drug monitoring-guided cohort
Time Frame: From Day 1 to Day 70 post-enrolment
Time interval in days between consecutive oritavancin doses in participants managed using therapeutic drug monitoring-guided dosing.
From Day 1 to Day 70 post-enrolment
Number of participants with treatment-emergent adverse events in the oritavancin cohorts
Time Frame: From enrolment to Day 180 post-enrolment
Number of participants receiving oritavancin with at least 1 treatment-emergent adverse event.
From enrolment to Day 180 post-enrolment
Number of participants with serious adverse events in the oritavancin cohorts
Time Frame: From enrolment to Day 180 post-enrolment
Number of participants receiving oritavancin with at least 1 serious adverse event.
From enrolment to Day 180 post-enrolment
Number of participants with infusion-related reactions in the oritavancin cohorts
Time Frame: From enrolment to Day 180 post-enrolment
Number of participants receiving oritavancin with at least 1 infusion-related reaction.
From enrolment to Day 180 post-enrolment
Proportion of participants completing protocol-specified dosing and monitoring through Day 70
Time Frame: From enrolment to Day 70 post-enrolment
Proportion of participants who complete the protocol-specified dosing schedule and planned therapeutic drug monitoring/sample collection through Day 70.
From enrolment to Day 70 post-enrolment
Recruitment rate
Time Frame: From study opening to completion of enrolment
Proportion of eligible participants who are enrolled into the study.
From study opening to completion of enrolment
Retention rate at Day 70
Time Frame: From enrolment to Day 70 post-enrolment
Proportion of enrolled participants who complete Day 70 follow-up.
From enrolment to Day 70 post-enrolment
Number of participants who complete planned study treatment
Time Frame: By Day 70 post-enrolment
Number of participants who complete their planned study treatment course as determined by the treating clinician and protocol-defined study treatment period.
By Day 70 post-enrolment
Number of participants with clinical or microbiological failure
Time Frame: By Day 70 post-enrolment
Number of participants with clinical or microbiological failure, including worsening or recurrent signs of cardiac infection, need for change/addition of antibiotic therapy due to inadequate response, or relapse with the same organism following study treatment.
By Day 70 post-enrolment
Number of participants with hospital readmission by Day 70
Time Frame: By Day 70 post-enrolment
Number of participants with at least 1 hospital readmission.
By Day 70 post-enrolment
Number of participants who die by Day 70
Time Frame: By Day 70 post-enrolment
All-cause mortality.
By Day 70 post-enrolment
Number of participants with hospital readmission by Day 180
Time Frame: By Day 180 post-enrolment
Number of participants with at least 1 hospital readmission.
By Day 180 post-enrolment
Number of participants who die by Day 180
Time Frame: By Day 180 post-enrolment
All-cause mortality.
By Day 180 post-enrolment
Change from Baseline to Day 70 in EuroQol 5-Dimension 5-Level Index Score
Time Frame: Baseline to Day 70 post-enrolment
Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L). The EQ-5D-5L index score is derived from participant responses across five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Using the Australian EQ-5D-5L value set, possible index scores range from -0.30 to 1.00, where 1.00 represents full health, 0 represents a health state equivalent to death, and scores below 0 represent health states valued worse than death. Higher scores indicate better health-related quality of life. Change will be calculated as the Day 70 score minus the baseline score; a positive change indicates improvement.
Baseline to Day 70 post-enrolment

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.
Kirby Institute

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.
  • Principal Investigator: Gail Matthews, MBChB MRCP(UK) FRACP PhD FAAHM, Kirby Institute

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 (Estimated)

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.
July 1, 2026

Primary Completion (Estimated)

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.
June 30, 2028

Study Completion (Estimated)

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.
September 30, 2028

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).
March 26, 2026

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.
April 19, 2026

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.
April 24, 2026

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.
April 29, 2026

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.
April 23, 2026

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.
April 1, 2026

More Information

Terms related to this study

Keywords

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.
  • OSCAR

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

No

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.

Clinical Trials on Infective Endocarditis

Clinical Trials on Oritavancin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings