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New antibiotic strategy could shorten hospital stays for heart infections

NCT ID NCT07550595

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study tests a long-acting antibiotic called oritavancin for treating gram-positive heart infections, such as infective endocarditis. The goal is to see if weekly IV doses can replace the usual weeks-long hospital stays and daily antibiotics. The study will enroll 20 adults and compare standard dosing with dosing guided by drug level monitoring.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Oritavancin (an antibiotic given by IV)
What this could lead to
If successful, this could offer a shorter, more convenient antibiotic treatment for serious heart infections, potentially reducing hospital stays and improving access for people who inject drugs.
What could go wrong
This is a small, early-phase pilot study with only 20 participants, so results may not apply broadly. Oritavancin is not yet approved for heart infections, and optimal dosing is still uncertain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Prince of Wales Hospital

    Sydney, New South Wales, 2031, Australia

  • Royal Prince Alfred Hospital

    Sydney, New South Wales, 2050, Australia

  • St Vincent's Hospital

    Sydney, New South Wales, 2010, Australia

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