Oritavancin for Staphylococcus Aureus Infections in Opioid Users

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT03761953
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arm: 1
• Actual Duration (Months): 32.8
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Staphylococcus Aureus Bacteremia; Staphylococcus Aureus Endocarditis	Drug: Oritavancin Injection	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: This will be a pilot single-arm study consisting of 15 patients 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.This will be a pilot single-arm study consisting of 15 patients 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.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jul 1, 2019
• Actual Primary Completion Date: Mar 24, 2022
• Actual Study Completion Date: Mar 24, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Oritavancin Single IV infusion of 1200mg of oritavancin	Drug: Oritavancin Injection; single 1200mg infusion of IV oritavancin.

Outcome Measures

Primary Outcome Measures

1. Frequency of grade 3 or 4 systemic (i.e., not a local reaction) adverse events associated with the administration of oritavancin [6 weeks]

   Safety

2. Frequency of relapse of infection [6 weeks]

   Efficacy

Secondary Outcome Measures

1. Duration of hospitalization [6 weeks]

   Duration of hospitalization

2. Relapse of systemic S. aureus infections [6 weeks]

   Relapse of systemic S. aureus infections. Relapse will be defined as an isolation of the same S. aureus strain in subsequent cultures

3. Pharmacokinetic parameters of oritavancin: Cmin (μg/ml) [6 weeks]

   Cmin (μg/ml) at week 1, 2, 4 and 6 after the administration of oritavancin

4. Patient satisfaction when using oritavancin measured using the Patient Satisfaction Questionnaire Short Form (PSQ-18) [6 weeks]

   Patient satisfaction will be measured using The Patient Satisfaction Questionnaire Short Form (PSQ-18)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Trials Unit. University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104--607

Sponsors and Collaborators

• University of Pennsylvania

Investigators

• Principal Investigator: Pablo Tebas, MD, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT03761953
• Other Study ID Numbers: 831334
• First Posted: Dec 3, 2018
• Last Update Posted: Apr 6, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Staphylococcal Infections; Bacteremia; Endocarditis; Oritavancin

Study Results

No Results Posted as of Apr 6, 2022