Status:
WITHDRAWN
Oritavancin for Staphylococcus Aureus Infections in Opioid Users
Lead Sponsor:
University of Pennsylvania
Conditions:
Staphylococcus Aureus Bacteremia
Staphylococcus Aureus Endocarditis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 Staphyl...
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 24 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03761953
Start Date
July 1 2019
End Date
March 24 2022
Last Update
April 6 2022
Active Locations (1)
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1
Clinical Trials Unit. University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104--607