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)

NCT02452918 | Completed Phase 4 Results

• 1 other identifier: MDCO-ORI-14-03
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Bacterial Skin and Skin Structure Infection

Keywords

skin infection

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment, including abnormal vital signs or laboratory assessments. An SAE was defined as any untoward medical occurrence that at any dose resulted in any of the following outcomes as fatal, life-threatening, required in-participant hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, an important medical event. A summary of all SAEs and Other AEs (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

  Up to 2 weeks after first administration of oritavancin

Secondary Outcomes (1)

• Number of Participants With a Clinical Response of Cure

  At 48 to 72 hours after start of oritavancin dose and at Day 7

Study Arms (2)

Oritavancin 1200 mg Without Concomitant Warfarin Therapy

EXPERIMENTAL

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

Drug: Oritavancin

Oritavancin 1200 mg With Concomitant Warfarin Therapy

EXPERIMENTAL

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

Drug: Oritavancin; Drug: Warfarin

Interventions

Oritavancin DRUG

Administered intravenously

Also known as: Orbactiv

Oritavancin 1200 mg With Concomitant Warfarin Therapy; Oritavancin 1200 mg Without Concomitant Warfarin Therapy

Warfarin DRUG

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

Oritavancin 1200 mg With Concomitant Warfarin Therapy

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Medicines Company: lead

Study Sites (1)

Unknown Facility

Somers Point, New Jersey, 08244, United States

Location

MeSH Terms

Conditions

Cellulitis

Interventions

oritavancin; Warfarin

Condition Hierarchy (Ancestors)

Skin Diseases, Infectious; Infections; Suppuration; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Study Director
• Organization: Melinta Therapeutics

medinfo@melinta.com

1-844-633-6568

Study Officials

• Medical Information

  Melinta Therapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2015
• First Posted: May 25, 2015
• Study Start: September 29, 2015
• Primary Completion: July 5, 2016
• Study Completion: July 5, 2016
• Last Updated: December 20, 2023
• Results First Posted: December 20, 2023

Record last verified: 2023-12

Locations

US (1)