2925416
Last Update Posted: 2024-02-01
Recruiting has ended
All Genders accepted | 18 Years + |
22 Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
Safety of Either a Single or Two Intravenous Doses of Orbactiv in Participants With Acute Bacterial Skin and Skin Structure Infection
The purpose of this study was to evaluate the safety and tolerability of two 1200 milligram (mg) intravenous (IV) infusions of oritavancin when administered one week apart.
Clinical studies in adult participants with acute bacterial skin and skin structure infection (ABSSSI) have demonstrated that a single 1200-mg IV dose of oritavancin was clinically non-inferior, well tolerated, and had a similar safety profile to 7 to 10 days of IV vancomycin treatment. The 1200-mg dose of oritavancin is the United States approved therapeutic dose.
Participants with ABSSSI were enrolled in this study to obtain safety information of two 1200-mg IV infusions of oritavancin when administered one week apart.
Eligibility
Relevant conditions:
Skin Diseases, Bacterial
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the trial if you think are close to fitting criteria.
locations
Data sourced from ClinicalTrials.gov