A Study for Patients With Complicated Skin and Skin Structure Infections

Study Overview
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Brief Summary
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Two Phase III trials to demonstrate the efficacy and safety of oritavancin in the treatment of complicated skin and skin structure infections (cSSSI) have been completed. The pharmacokinetic profile of oritavancin in humans suggests that oritavancin has the potential to be used safely and effectively when given either as a single dose or as an infrequent dose for cSSSI. Data from animals support this theory. SIMPLIFI has been designed to evaluate the efficacy and safety of either a single dose of oritavancin or an infrequent dose of oritavancin (First dose on Day one with an option for a second dose on Day five) compared to the previously studied dosing regimen of 200mg oritavancin given once daily for 3 to 7 days.

Official Title
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Nuvocid® (Oritavancin) at Single or Infrequent Doses for the Treatment of Complicated Skin and Skin Structure Infections (SIMPLIFI)

Conditions
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Staphylococcal Skin Infections, Wounds and Injuries, Abscess, Cellulitis, Streptococcal Infections

Intervention / Treatment
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* Drug: oritavancin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Complicated skin and skin structure infection, presumed or proven to be caused by gram-positive pathogen(s). Patients, ages 18 years and older, must not be below normal body weight or morbidly obese. Female patients must not be pregnant at time of enrollment and must agree to a reliable method of birth control during the study and for 6 months following the last dose of study drug. Exclusion Criteria: Patients: with a condition which would prevent performing protocol safety and efficacy assessments. who have received antibiotics for more than 24 hours within the last 3 days. with an infection involving deep tissues or unlikely to be caused by gram positive bacteria who are nursing and will not stop nursing for at least 6 months with a prior allergic reaction to glycopeptides (e.g. vancomycin) with any of the following: toxic shock syndrome or toxic-like syndrome presumed or proven infection caused by Clostridium species bone infections ischemic or gangrenous ulcers or wounds infections caused only by gram-negative bacteria infection of an artificial joint that cannot be removed infection of the scrotum, perineum or perianal region infection of a severe burn wound severe ear infection involving bone and/or cartilage infection following injury in water possibly containing Vibrio species or following a history of eating raw oysters within 1 week prior to disease onset

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: oritavancin<br>* Oritavancin as a single, infrequent or daily dose.<br>|
| Experimental: 2<br> | Drug: oritavancin<br>* Oritavancin as a single, infrequent or daily dose.<br>|
| Experimental: 3<br> | Drug: oritavancin<br>* Oritavancin as a single, infrequent or daily dose.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical success at follow-up |  | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate safety of dosing regimens. |  | six months |