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A Study to Evaluate the Safety of a Single Intravenous (IV) Dose of Orbactiv (Oritavancin) in Participants on Chronic Warfarin Therapy Being Treated For Acute Bacterial Skin and Skin Structure Infection (ABSSSI)

NCT ID: NCT02452918

Last Updated: 2023-12-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-29

Study Completion Date

2016-07-05

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Bacterial Skin and Skin Structure Infection

Keywords

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skin infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oritavancin 1200 mg Without Concomitant Warfarin Therapy

Oritavancin as a single 1200 mg IV dose administered over 3 hours in participants with ABSSSI who were not on concomitant warfarin therapy

Group Type EXPERIMENTAL

Oritavancin

Intervention Type DRUG

Administered intravenously

Oritavancin 1200 mg With Concomitant Warfarin Therapy

Oritavancin as a single 1200 mg IV dose administered over 3 hours in participants with ABSSSI who were on concomitant warfarin therapy at a standard dose and dosing schedule

Group Type EXPERIMENTAL

Oritavancin

Intervention Type DRUG

Administered intravenously

Warfarin

Intervention Type DRUG

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

Interventions

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Oritavancin

Administered intravenously

Intervention Type DRUG

Warfarin

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

Intervention Type DRUG

Other Intervention Names

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Orbactiv

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of ABSSSI (wound infection, cellulitis/erysipelas, or cutaneous abscess) suspected or confirmed to be caused by a Gram-positive pathogen requiring IV therapy
* Must be currently being treated with chronic warfarin therapy\* \*Participants in the non-warfarin group are not required to be on chronic warfarin therapy.

Exclusion Criteria

* Known or suspected bacteremia, sepsis or refractory shock
* Participants who are likely to need treatment with IV heparin within 48 hours
* Significant or life-threatening condition
* Women who are pregnant or nursing
* Receiving chronic systemic immunosuppressive therapy such as chemotherapy or prednisone
* CD4 count \<200 cells/mm\^3 in participants with known human immunodeficiency virus or acquired immune deficiency syndrome
* Neutropenia
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Medicines Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Information

Role: STUDY_DIRECTOR

Melinta Therapeutics, Inc.

Locations

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Somers Point, New Jersey, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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MDCO-ORI-14-03

Identifier Type: -

Identifier Source: org_study_id