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Oritavancin for Staphylococcus Aureus Infections in Opioid Users

NCT03761953 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2022-04-06

No results posted yet for this study

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

Interventions

DRUG

Oritavancin Injection

single 1200mg infusion of IV oritavancin.

Sponsors & Collaborators

Principal Investigators

  • Pablo Tebas, MD · University of Pennsylvania

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2022-03-24
Completion
2022-03-24
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03761953 on ClinicalTrials.gov