Oritavancin for Staphylococcus Aureus Infections in Opioid Users
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Cardiology, Infectious Disease, Hospital |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Immunology / Infectious Diseases, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/5/2018 |
| Start Date: | January 1, 2019 |
| End Date: | December 31, 2019 |
| Contact: | Pablo Tebas, MD |
| Email: | pablo.tebas@uphs.upenn.edu |
| Phone: | 2679755735 |
A Pilot Proof of Concept Single-Center Study of the Use of Oritavancin in Systemic Staphylococcus Aureus Infections in Patients With Opioid Use Disorder
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.
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.
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.
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
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