NCT00514527

A Study for Patients With Complicated Skin and Skin Structure Infections

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 294 (estimated)
• Sponsor: Targanta Therapeutics Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Staphylococcal Skin Infections
• Wounds and Injuries
• Abscess
• Cellulitis
• Streptococcal Infections

Interventions

Type	Name	Description
DRUG	oritavancin	Oritavancin as a single, infrequent or daily dose.

Timeline

• Start date: 2007-08-01
• Primary completion: 2008-04-01
• Completion: 2008-05-01
• First posted: 2007-08-10
• Last updated: 2008-08-14

Locations

66 sites across 6 countries: United States, Australia, India, Italy, Romania, Ukraine