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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
single 1200mg infusion of IV oritavancin.
Clinical Trials Unit. University of Pennsylvania
Philadelphia, Pennsylvania, United States
Frequency of grade 3 or 4 systemic (i.e., not a local reaction) adverse events associated with the administration of oritavancin
Safety
Time frame: 6 weeks
Frequency of relapse of infection
Efficacy
Time frame: 6 weeks
Duration of hospitalization
Duration of hospitalization
Time frame: 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
Time frame: 6 weeks
Pharmacokinetic parameters of oritavancin: Cmin (μg/ml)
Cmin (μg/ml) at week 1, 2, 4 and 6 after the administration of oritavancin
Time frame: 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)
Time frame: 6 weeks
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