Trial | NCT00514527  Report issue

Title

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)

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    294
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.
Study Started
Aug 31
2007
Primary Completion
Apr 30
2008
Study Completion
May 31
2008
Last Update
Aug 14
2008
Estimate

Drug oritavancin

Oritavancin as a single, infrequent or daily dose.

1 Experimental

2 Experimental

3 Experimental

Criteria 

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
No Results Posted