A Study for Patients With Complicated Skin and Skin Structure Infections

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Staphylococcal Skin Infections Abscess Bacterial Infections Bacterial Infections and Mycoses Cellulitis Connective Tissue Diseases Gram-Positive Bacterial Infections Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Staphylococcal Infections Streptococcal Infections Suppuration Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Targanta Recruiting Site, Cairns, Queensland, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oritavancin

Drug

Oritavancin as a single, infrequent or daily dose.

Primary outcomes

Clinical success at follow-up

Time frame: six months

Secondary outcomes

To evaluate safety of dosing regimens.

Time frame: six months

Sponsors and collaborators

Lead sponsor

Targanta Therapeutics Corporation

Industry

Registry information

Official study title

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

Acronym: SIMPLIFI

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2008
First posted: Aug 10, 2007
Registry last updated: Aug 14, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed