Oritavancin for Staphylococcus Aureus Infections in Opioid Users

NCT ID: NCT03761953

Last Updated: 2022-04-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2022-03-24

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.

Conditions

Staphylococcus Aureus Bacteremia; Staphylococcus Aureus Endocarditis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oritavancin

Single IV infusion of 1200mg of oritavancin

Group Type: EXPERIMENTAL

Oritavancin Injection

Intervention Type: DRUG

single 1200mg infusion of IV oritavancin.

Interventions

Oritavancin Injection

single 1200mg infusion of IV oritavancin.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pablo Tebas, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Clinical Trials Unit. University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

831334

Identifier Type: -

Identifier Source: org_study_id