CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 17 enrolled
Drug / intervention
Oritavancin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02452918
NCT02452918Phase 4Completed
CompareCT.gov

An Open-Label Study to Evaluate the Safety of a Single 1200 mg IV Dose of Orbactiv (Oritavancin) in Subjects on Concomitant Chronic Warfarin Therapy Being Treated For Acute Bacterial Skin and Skin Structure Infection (ABSSSI)

The Medicines Company·interventional·Posted May 25, 2015·Updated Dec 20, 2023

In Brief

A Phase 4 clinical trial evaluating Oritavancin and Warfarin for Acute Bacterial Skin and Skin Structure Infection. Completed, enrolled 17 participants across 1 site.

Detailed Summary

This was a Phase 4, multicenter, open-label safety study of a single 1200 milligrams (mg) IV infusion of oritavancin in adult participants on chronic warfarin with acute bacterial skin and skin structure infection (ABSSSI) suspected or proven to be caused by Gram-positive pathogens. An additional group of participants with ABSSSI, who were not on concomitant warfarin therapy, were also enrolled to obtain additional information following a single dose of oritavancin administration.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Bacterial Skin and Skin Structure Infection
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 25, 2015
Enrollment StartSep 29, 2015
Primary CompletionJul 5, 2016
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 11.1 years ago

Interventions

Oritavancindrug

Administered intravenously

Warfarindrug

Administered as a concomitant medication at a standard dose and dosing schedule