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)

Acute Bacterial Skin and Skin Structure Infection Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02452918
• Other study ID #: MDCO-ORI-14-03
• Status: Completed
• Phase: Phase 4
• Start date: September 29, 2015
• Est. completion date: July 5, 2016

Study information

• Verified date: December 2023
• Source: The Medicines Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: July 5, 2016
• Est. primary completion date: July 5, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Bacterial Skin and Skin Structure Infection
• Communicable Diseases
• Infections
• Skin Diseases, Bacterial

Intervention

Drug:
• Oritavancin
Administered intravenously
• Warfarin
Administered as a concomitant medication at a standard dose and dosing schedule

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Medicines Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants With a Clinical Response of Cure	Participants were classified by investigator assessment as "success" for clinical response of cure if all of the following were met: cessation of spread or reduction of the lesion; resolution (absence) of fever (temperature less than 37.7° Celsius); no rescue antibiotic medication; complete or nearly complete resolution of baseline signs and symptoms of the primary infection such that no further treatment with antibiotics was needed.	At 48 to 72 hours after start of oritavancin dose and at Day 7