Phase 4
N=17
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
Bottom Line
View on ClinicalTrials.gov: NCT02452918 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) — 2; 1; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Oritavancin (Drug); Warfarin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Medicines Company
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
2; 1; 0; 0 | — |
| SECONDARY Number of Participants With a Clinical Response of Cure |
15; 2 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02452918). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.