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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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT02452918
Study type Interventional
Source The Medicines Company
Contact
Status Completed
Phase Phase 4
Start date September 29, 2015
Completion date July 5, 2016

See also
  Status Clinical Trial Phase
Completed NCT04298463 - Retrospective Effectiveness Study of Dalbavancin and Other Standard of Care of the Same Class in Patients With ABSSSI
Recruiting NCT05599295 - Study to Evaluate the Safety and Tolerability of Single-Dose Intravenous (IV) Oritavancin Phase 2
Completed NCT03233438 - Development of a New Critical Pathway for Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Phase 4
Completed NCT03873987 - Relative Exposure and Safety Study of Kimyrsa in ABSSSI Patients Phase 1
Not yet recruiting NCT04229511 - Development of Risk Score Model and Decision Tree Algorithm for Predicting Infections With CRKp in Colonized Patients