Oritavancin for Staphylococcus Aureus Infections in Opioid Users

Staphylococcus Aureus Bacteremia Clinical Trial

Official title:

A Pilot Proof of Concept Single-Center Study of the Use of Oritavancin in Systemic Staphylococcus Aureus Infections in Patients With Opioid Use Disorder

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03761953
• Other study ID #: 831334
• Status: Withdrawn
• Phase: Phase 4
• Start date: July 1, 2019
• Est. completion date: March 24, 2022

Study information

• Verified date: March 2022
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 24, 2022
• Est. primary completion date: March 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bacteremia
• Endocarditis
• Staphylococcal Infections
• Staphylococcus Aureus Bacteremia
• Staphylococcus Aureus Endocarditis

Intervention

Drug:
• Oritavancin Injection
single 1200mg infusion of IV oritavancin.

Locations

Country	Name	City	State
United States	Clinical Trials Unit. University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of grade 3 or 4 systemic (i.e., not a local reaction) adverse events associated with the administration of oritavancin	Safety	6 weeks
Primary	Frequency of relapse of infection	Efficacy	6 weeks
Secondary	Duration of hospitalization	Duration of hospitalization	6 weeks
Secondary	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	6 weeks
Secondary	Pharmacokinetic parameters of oritavancin: Cmin (µg/ml)	Cmin (µg/ml) at week 1, 2, 4 and 6 after the administration of oritavancin	6 weeks
Secondary	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)	6 weeks