Oritavancin for Staphylococcus Aureus Infections in Opioid Users

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pennsylvania
• Treatments: Oritavancin

Criteria

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