Oritavancin for Staphylococcus Aureus Infections in Opioid Users

NCT03761953 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: 831334
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Staphylococcus Aureus Bacteremia; Staphylococcus Aureus Endocarditis

Outcome Measures

Primary Outcomes (2)

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

  Safety

  6 weeks

• Frequency of relapse of infection

  Efficacy

  6 weeks

Secondary Outcomes (4)

• Duration of hospitalization

  6 weeks

• Relapse of systemic S. aureus infections

  6 weeks

• Pharmacokinetic parameters of oritavancin: Cmin (μg/ml)

  6 weeks

• Patient satisfaction when using oritavancin measured using the Patient Satisfaction Questionnaire Short Form (PSQ-18)

  6 weeks

Study Arms (1)

Oritavancin

EXPERIMENTAL

Single IV infusion of 1200mg of oritavancin

Drug: Oritavancin Injection

Interventions

Oritavancin Injection DRUG

single 1200mg infusion of IV oritavancin.

Oritavancin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Clinical Trials Unit. University of Pennsylvania

Philadelphia, Pennsylvania, 19104--607, United States

Location

MeSH Terms

Interventions

oritavancin

Study Officials

• Pablo Tebas, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 9, 2018
• First Posted: December 3, 2018
• Study Start: July 1, 2019
• Primary Completion: March 24, 2022
• Study Completion: March 24, 2022
• Last Updated: April 6, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)