Oritavancin for Staphylococcus Aureus Infections in Opioid Users

A Pilot Proof of Concept Single-Center Study of the Use of Oritavancin in Systemic Staphylococcus Aureus Infections in Patients With Opioid Use Disorder

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.

This will be an early phase, single center, open label pilot study of 15 participants designed to evaluate the effects of oritavancin in patients with Opioid Use Disorder and/or Intravenous Drug Use and systemic S. aureus infections. In this study systemic infections refers to bacteremia or Infectious Endocarditis. Participants who meet inclusion and exclusion criteria will receive a single 1200mg infusion of oritavancin to complete 4 weeks of antibiotic therapy (including the inpatient phase) for isolated bacteremia and 6 weeks for IE. Participants will be evaluated weekly until completion of treatment and then at week 4 and week 6 after the infusion of oritavancin. Participants will have blood drawn at each visit to monitor for toxicity and pharmacokinetics and will be evaluated clinically and by culture for the presence of relapse of the infection. At the last visit, participants will have an echocardiogram.

This will be a pilot single-arm study consisting of 15 patients 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.

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

Relapse of systemic S. aureus infections. Relapse will be defined as an isolation of the same S. aureus strain in subsequent cultures

Patient satisfaction when using oritavancin measured using the Patient Satisfaction Questionnaire Short Form (PSQ-18)

Patient satisfaction will be measured using The Patient Satisfaction Questionnaire Short Form (PSQ-18)

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