WithdrawnPhase 4

Oritavancin for Staphylococcus Aureus Infections in Opioid Users

Stopped: COVID 19 pandemic

United States0Started 2019-07-01

Plain-language summary

This will be a pilot single-arm study consisting of 15 participants evaluating the use of oritavancin in the final consolidation phase (last two weeks of treatment) of systemic infections with Staphylococcus aureus (S. aureus) in opioid users. The purpose of this pilot proposal is to collect information for a subsequent large, randomized intervention. Primary endpoints will be 1) Safety and tolerability, and 2) Duration of hospitalization and rate of recurrence.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 18 years of age and older * Systemic infection with S. aureus * Afebrile for \>48 hours * Negative blood cultures for at least 48 hours * Absolute neutrophil count (ANC) equal or greater 750/mm3 * Hemoglobin \> 9.0 g/dL * Platelet count equal or \> 50,000/mm3 * Creatinine \< 2.0 x ULN * AST ; ALT, and alkaline phosphatase \< 2.0 x ULN * Willing to use a medically accepted method of contraception Exclusion Criteria: * Require valve replacement surgery * Have prosthetic material in body (This includes prosthetic heart valves and/or prosthetic joints) * Septic emboli to central nervous system or lungs * Breast feeding during entire participation * Pregnant * Polymicrobial infection * Require anticoagulation * Allergy to vancomycin or oritavancin

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Frequency of grade 3 or 4 systemic (i.e., not a local reaction) adverse events associated with the administration of oritavancin

Timeframe: 6 weeks

Frequency of relapse of infection

Timeframe: 6 weeks

Trial details

NCT IDNCT03761953

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03-24

View on ClinicalTrials.gov More Staphylococcus Aureus Bacteremia trials