Safety of Either a Single or Two Intravenous Doses of Orbactiv in Participants With Acute Bacteri⦠(NCT02925416) | Clinical Trial Compass
CompletedPhase 4
Safety of Either a Single or Two Intravenous Doses of Orbactiv in Participants With Acute Bacterial Skin and Skin Structure Infection
United States22 participantsStarted 2017-01-24
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Diagnosis of ABSSSI (wound infections, cellulitis/erysipelas, or cutaneous abscess) suspected or confirmed to be caused by a Gram-positive pathogen requiring IV therapy
* Able to give informed consent and willing to comply with all required study procedures
Exclusion Criteria:
* 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 or associated with any of the following:
* Infections suspected or documented to be caused by Gram-negative pathogens (i.e., human or animal bites, injuries contaminated with fresh or salt water, external malignant otitis)
* Wound infections (surgical or traumatic) and abscesses with only Gram-negative pathogens
* Diabetic foot infections (infection extending distal to the malleoli in a participant with diabetes mellitus and peripheral neuropathy and/or vascular insufficiency or any ulceration of their foot)
* Concomitant infection at another site not including a secondary ABSSSI lesion (e.g., septic arthritis, endocarditis, osteomyelitis)
* Infected burns
* A primary infection secondary to a pre-existing skin disease with associated inflammatory changes such as atopic dermatitis, eczema, or hidradenitis suppurativa
* Decubitus or chronic skin ulcer, or ischemic ulcer due to peripheral vascular disease (arterial or venous)
* Any evolving necrotizing process (i.e., necrotizing fasciitiā¦
What they're measuring
1
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: Up to Day 21 after first administration of oritavancin