At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 22 enrolled
Drug / intervention
Oritavancin +1 moredrug
Likely dose
1200 mg intravenously as a single dose or two IV dosesAI-extracted
Key inclusion· 2
- ✓Diagnosis of ABSSSI (wound infection, cellulitis/erysipelas, or cutaneous abscess) suspected or confirmed to be caused by Gram-positive pathogen requiring IV therapy
- ✓Able to give informed consent and willing to comply with all required study procedures
Key exclusion· 11
- ✕Infections associated with or in close proximity to a prosthetic device
- ✕Severe sepsis or refractory shock
- ✕Known or suspected bacteremia at time of screening
- ✕ABSSSI due to Gram-negative pathogens including human/animal bites, water contamination, or external malignant otitis
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-Blind, Randomized Study to Evaluate the Safety of Either a Single 1200-mg Intravenous (IV) Dose of Orbactiv™ (Oritavancin) and Placebo or Two IV Doses of Orbactiv™ in Subjects Being Treated for Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
In Brief
A Phase 4 clinical trial evaluating Oritavancin and Placebo (D5W) for Skin Diseases, Bacterial. Completed, enrolled 22 participants across 1 site.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSkin Diseases, Bacterial
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedOct 2016
Enrollment StartJan 2017
Primary CompletionJun 2017
TodayJul 2026
First PostedOct 5, 2016
Enrollment StartJan 24, 2017
Primary CompletionJun 20, 2017
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 9.7 years ago
Interventions
Oritavancindrug
Administered intravenously
Placebo (D5W)drug
Administered intravenously