Oritavancin for Staphylococcus Aureus Infections in Opioid Users

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Endocarditis

Intervention / Treatment
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* Drug: Oritavancin Injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oritavancin<br>Single IV infusion of 1200mg of oritavancin | Drug: Oritavancin Injection<br>* single 1200mg infusion of IV oritavancin.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of grade 3 or 4 systemic (i.e., not a local reaction) adverse events associated with the administration of oritavancin | Safety | 6 weeks | 
| Frequency of relapse of infection | Efficacy | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of hospitalization | Duration of hospitalization | 6 weeks | 
| Relapse of systemic S. aureus infections | Relapse of systemic S. aureus infections. Relapse will be defined as an isolation of the same S. aureus strain in subsequent cultures | 6 weeks | 
| Pharmacokinetic parameters of oritavancin: Cmin (μg/ml) | Cmin (μg/ml) at week 1, 2, 4 and 6 after the administration of oritavancin | 6 weeks | 
| 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) | 6 weeks |