Infective EndocarditisPhase 2OSCARNCT07550595
Oritavancin for Treatment of Serious Cardiac Infections
A Phase 2 study testing Oritavancin in people with Infective Endocarditis and Cardiac Device Infection, run by Kirby Institute at 3 sites in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infective Endocarditis, Cardiac Device Infection, Gram-positive Bacterial Infections
- What is being tested?
- Oritavancin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesAustralia
- Study dates
- 1 Jul 2026to 30 Sep 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Hospitalised for management of a cardiac infection (infective endocarditis or cardiovascular implantable electronic device infections)
- 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)
- Afebrile for at least 24 hours at screening
- Clearance of blood cultures for at least 24 hours at screening
- Receiving effective antibiotic therapy for at least 24 hours and no more than 14 days at screening
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- Willingness of both treating provider and participant to proceed with oritavancin therapy
- Able to provide written informed consent
- Willingness and ability to participate in study procedures, including follow-up visits and drug monitoring
Who cannot join
- History of severe allergic reaction or hypersensitivity to oritavancin or any of its components
- Severe renal impairment (eGFR < 30 mL/min/1.73 m²) or currently receiving dialysis
- Severe hepatic impairment (Child-Pugh class C)
- 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).
- Presence of prosthetic heart valve
- Culture negative endocarditis
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- Presence of any other active infection requiring concurrent antibiotic treatment that could interfere with study outcomes
- Infection with Gram positive organism not susceptible to oritavancin or vancomycin (vancomycin MIC > 2 μg/mL).
- Use of contraindicated medications (see Section 8)
- Participation in another interventional clinical trial that may confound study outcomes
- 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).
- 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).
- 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
- Medically unstable in opinion of treating clinician that would preclude participation
- 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).
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia3 sites
St Vincent's Hospital
Sydney, New South Wales, 2010
David Goodman
Prince of Wales Hospital
Sydney, New South Wales, 2031
Marianne Martinello
Royal Prince Alfred Hospital
Sydney, New South Wales, 2050
About this study
Official title: 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.
- Being tested
- Oritavancin
- Keywords
- Oritavancin, Long-acting antibiotic, Lipoglycopeptide, Infective endocarditis, Cardiac device infection, Gram-positive infection, Therapeutic drug monitoring, Pharmacokinetics
- Medical subject headings
- Endocarditis, Gram-Positive Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OritavancinDrug
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)
OritavancinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A1: Oritavancin, guideline-based dosing | Experimental | 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 Receives: Drug: Oritavancin |
| Cohort A2: Oritavancin (TDM-guided dosing) | Experimental | 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 Receives: Drug: Oritavancin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Desirability of Outcome Ranking (DOOR) at Day 70
Composite ordinal outcome adapted for Gram-positive cardiac infections. Participants will be ranked from most to least desirable outcome as follows:
- = alive with no clinical failure, infectious complication, or serious adverse event/adverse event leading to study drug discontinuation;
- = alive with 1 of these events;
- = alive with 2 of these events;
- = alive with all 3 of these events;
- = 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.
Measured: Day 70 post-enrolment
Secondary outcomes (15)
Total oritavancin plasma concentration at scheduled sampling time points
Observed total oritavancin plasma concentrations measured at protocol-specified sampling time points to support development of the population pharmacokinetic model.
Measured: From post-dose Day 1 through Day 70 post-enrolment
Oritavancin dosing interval achieved in the therapeutic drug monitoring-guided cohort
Time interval in days between consecutive oritavancin doses in participants managed using therapeutic drug monitoring-guided dosing.
Measured: From Day 1 to Day 70 post-enrolment
Number of participants with treatment-emergent adverse events in the oritavancin cohorts
Number of participants receiving oritavancin with at least 1 treatment-emergent adverse event.
Measured: From enrolment to Day 180 post-enrolment
Number of participants with serious adverse events in the oritavancin cohorts
Number of participants receiving oritavancin with at least 1 serious adverse event.
Measured: From enrolment to Day 180 post-enrolment
Number of participants with infusion-related reactions in the oritavancin cohorts
Number of participants receiving oritavancin with at least 1 infusion-related reaction.
Measured: From enrolment to Day 180 post-enrolment
Change from Baseline to Day 70 in EuroQol 5-Dimension 5-Level Index Score
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.
Measured: Baseline to Day 70 post-enrolment
Proportion of participants completing protocol-specified dosing and monitoring through Day 70
Proportion of participants who complete the protocol-specified dosing schedule and planned therapeutic drug monitoring/sample collection through Day 70.
Measured: From enrolment to Day 70 post-enrolment
Recruitment rate
Proportion of eligible participants who are enrolled into the study.
Measured: From study opening to completion of enrolment
Retention rate at Day 70
Proportion of enrolled participants who complete Day 70 follow-up.
Measured: From enrolment to Day 70 post-enrolment
Number of participants who complete planned study treatment
Number of participants who complete their planned study treatment course as determined by the treating clinician and protocol-defined study treatment period.
Measured: By Day 70 post-enrolment
Number of participants with clinical or microbiological failure
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.
Measured: By Day 70 post-enrolment
Number of participants with hospital readmission by Day 70
Number of participants with at least 1 hospital readmission.
Measured: By Day 70 post-enrolment
Number of participants who die by Day 70
All-cause mortality.
Measured: By Day 70 post-enrolment
Number of participants with hospital readmission by Day 180
Number of participants with at least 1 hospital readmission.
Measured: By Day 180 post-enrolment
Number of participants who die by Day 180
All-cause mortality.
Measured: By Day 180 post-enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infective EndocarditisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Gail Matthews, MBChB MRCP(UK) FRACP PhD FAAHM, Principal investigator, Kirby Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07550595
- Sponsor's protocol ID
- OSCAR
- Acronym
- OSCAR
- Status last verified
- Apr 2026
- First submitted
- 26 Mar 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07550595
- Acronym / sponsor ID
- OSCAR / OSCAR
- Keywords
- Oritavancin, Long-acting antibiotic, Lipoglycopeptide, Infective endocarditis, Cardiac device infection, Gram-positive infection, Therapeutic drug monitoring, Pharmacokinetics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Kirby InstituteOther government
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 24 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A1: Oritavancin, guideline-based dosing | Experimental | Drug: OritavancinParticipants 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 |
| Cohort A2: Oritavancin (TDM-guided dosing) | Experimental | Drug: OritavancinParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥18 years
- Hospitalised for management of a cardiac infection (infective endocarditis or cardiovascular implantable electronic device infections)
- 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)
- Afebrile for at least 24 hours at screening
- Clearance of blood cultures for at least 24 hours at screening
Key exclusion criteria (15 listed)
- History of severe allergic reaction or hypersensitivity to oritavancin or any of its components
- Severe renal impairment (eGFR < 30 mL/min/1.73 m²) or currently receiving dialysis
- Severe hepatic impairment (Child-Pugh class C)
- 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).
- Presence of prosthetic heart valve
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OritavancinOritavancin 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 | Cohort A1: Oritavancin, guideline-based dosing |
| OritavancinParticipants 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. | Drug | Cohort A2: Oritavancin (TDM-guided dosing) |
Primary outcome
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.
15 secondary outcomes
Total oritavancin plasma concentration at scheduled sampling time points
Time frame: 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
Number of participants with treatment-emergent adverse events in the oritavancin cohorts
Time frame: 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 with infusion-related reactions in the oritavancin cohorts
Time frame: From enrolment to 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
Proportion of participants completing protocol-specified dosing and monitoring through Day 70
Time frame: From enrolment to Day 70 post-enrolment
Recruitment rate
Time frame: From study opening to completion of enrolment
Retention rate at Day 70
Time frame: 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 with clinical or microbiological failure
Time frame: By Day 70 post-enrolment
Number of participants with hospital readmission by Day 70
Time frame: By Day 70 post-enrolment
Number of participants who die by Day 70
Time frame: By Day 70 post-enrolment
Number of participants with hospital readmission by Day 180
Time frame: By Day 180 post-enrolment
Number of participants who die by Day 180
Time frame: By Day 180 post-enrolment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gail Matthews, MBChB MRCP(UK) FRACP PhD FAAHM principal investigator
Kirby Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oritavancin in people with Infective Endocarditis and Cardiac Device Infection, run by Kirby Institute at 3 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hila Haskelberg (61293850900, hhaskelberg@kirby.unsw.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Desirability of Outcome Ranking (DOOR) at Day 70 (time frame: Day 70 post-enrolment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.