Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Endocarditis
Conditions
Brief 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.
Detailed description
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.
Interventions
DRUGOritavancin Injection
single 1200mg infusion of IV oritavancin.
Sponsors
University of Pennsylvania
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of grade 3 or 4 systemic (i.e., not a local reaction) adverse events associated with the administration of oritavancin | 6 weeks | Safety |
| Frequency of relapse of infection | 6 weeks | Efficacy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of hospitalization | 6 weeks | Duration of hospitalization |
| Relapse of systemic S. aureus infections | 6 weeks | Relapse of systemic S. aureus infections. Relapse will be defined as an isolation of the same S. aureus strain in subsequent cultures |
| Pharmacokinetic parameters of oritavancin: Cmin (μg/ml) | 6 weeks | Cmin (μg/ml) at week 1, 2, 4 and 6 after the administration of oritavancin |
| Patient satisfaction when using oritavancin measured using the Patient Satisfaction Questionnaire Short Form (PSQ-18) | 6 weeks | Patient satisfaction will be measured using The Patient Satisfaction Questionnaire Short Form (PSQ-18) |
Countries
United States
Outcome results
None listed