Wounds and Injuries Clinical Trial
— SIMPLIFIOfficial title:
Nuvocid® (Oritavancin) at Single or Infrequent Doses for the Treatment of Complicated Skin and Skin Structure Infections (SIMPLIFI)
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.
| Status | Completed |
| Enrollment | 294 |
| Est. completion date | May 2008 |
| Est. primary completion date | April 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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: 1. toxic shock syndrome or toxic-like syndrome 2. presumed or proven infection caused by Clostridium species 3. bone infections 4. ischemic or gangrenous ulcers or wounds 5. infections caused only by gram-negative bacteria 6. infection of an artificial joint that cannot be removed 7. infection of the scrotum, perineum or perianal region 8. infection of a severe burn wound 9. severe ear infection involving bone and/or cartilage 10. infection following injury in water possibly containing Vibrio species or following a history of eating raw oysters within 1 week prior to disease onset |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Australia | Targanta Recruiting Site | Cairns | Queensland |
| Australia | Targanta Recruiting Site | East Ringwood | Victoria |
| Australia | Targanta Recruiting Site | Fremantle | |
| Australia | Targanta Recruiting Site | Nambour | Queensland |
| Australia | Targanta Recruiting Site | Parkville | Victoria |
| Australia | Targanta Recruiting Site | Woolloongabba | Queensland |
| India | Targanta Recruiting Site | Ahmedabad | Gujarat |
| India | Targanta Recruiting Site | Bangalore | Karnataka |
| India | Targanta Recruiting Site | Bangalore | Karnataka |
| India | Targanta Recruiting Site | Bangalore | Karnataka |
| India | Targanta Recruiting Site | Baroda | Gujarat |
| India | Targanta Recruiting Site | Hyderabaad | Andhra Pradesh |
| India | Targanta Recruiting Site | Kochi | Kerala |
| India | Targanta Recruiting Site | Lucknow | Uttar Pradesh |
| India | Targanta Recruiting Site | Mumbai | Maharashtra |
| India | Targanta Recruiting Site | Pune | Maharashtra |
| Italy | Targanta Recruiting Site | Catania | |
| Italy | Targanta Recruiting Site | Mantova | |
| Italy | Targanta Recruiting Site | Milano | |
| Italy | Targanta Recruiting Site | Pisa | |
| Italy | Targanta Recruiting Site | Savona | |
| Italy | Targanta Recruiting Site | Siena | |
| Romania | Targanta Recruiting Site | Bucharest | |
| Romania | Targanta Recruiting Site | Craiova | |
| Ukraine | Targanta Recruiting Site | Ivano-frankovsk | |
| Ukraine | Targanta Recruiting Site | Ivano-frankovsk | |
| Ukraine | Targanta Recruiting Site | Kharkov | |
| Ukraine | Targanta Recruiting Site | Kiev | |
| Ukraine | Targanta Recruiting Site | Kiev | |
| Ukraine | Targanta Recruiting Site | Kiev | |
| Ukraine | Targanta Recruiting Site | Odessa | |
| Ukraine | Targanta Recruiting Site | Ternopil | |
| Ukraine | Targanta Recruiting Site | Zaporizhzhya | |
| United States | Targanta Recruiting Site | Albany | New York |
| United States | Targanta Recruiting Site | Anaheim | California |
| United States | Targanta Recruiting Site | Arlington | Texas |
| United States | Targanta Recruiting Site | Atlantis | Florida |
| United States | Targanta Recruiting Site | Baton Rouge | Louisiana |
| United States | Targanta Recruiting Site | Buena Park | California |
| United States | Targanta Recruiting Site | Chula Vista | California |
| United States | Targanta Recruiting Site | Columbus | Georgia |
| United States | Targanta Recruiting Site | Columbus | Ohio |
| United States | Targanta Recruiting Site | Cumberland | Maryland |
| United States | Targanta Recruiting Site | Detroit | Michigan |
| United States | Targanta Recruiting Site | Hawaiian Gardens | California |
| United States | Targanta Recruiting Site | Houston | Texas |
| United States | Targanta Recruiting Site | Houston | Texas |
| United States | Targanta Recruiting Site | Indianapolis | Indiana |
| United States | Targanta Recruiting Site | Inverness | Florida |
| United States | Targanta Recruiting Site | Jackson | Tennessee |
| United States | Targanta Recruiting Site | Lafayette | Louisiana |
| United States | Targanta Recruiting Site | Long Beach | California |
| United States | Targanta Recruiting Site | Los Angeles | California |
| United States | Targanta Recruiting Site | Marietta | Georgia |
| United States | Targanta Recruiting Site | Miami | Florida |
| United States | Targanta Recruiting Site | Minneapolis | Minnesota |
| United States | Targanta Recruiting Site | Mobile | Alabama |
| United States | Targanta Recruiting Site | New Orleans | Louisiana |
| United States | Targanta Recruiting Site | Oceanside | California |
| United States | Targanta Recruiting Site | Rolling Hills Estates | California |
| United States | Targanta Recruiting Site | Salt Lake City | Utah |
| United States | Targanta Recruiting Site | San Jose | California |
| United States | Targanta Recruiting Site | Savannah | Georgia |
| United States | Targanta Recruiting Site | Springfield | Illinois |
| United States | Targanta Recruiting Site | Toledo | Ohio |
| United States | Targanta Recruiting Site | Torrance | California |
| Lead Sponsor | Collaborator |
|---|---|
| Targanta Therapeutics Corporation |
United States, Australia, India, Italy, Romania, Ukraine,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Clinical success at follow-up | six months | No | |
| Secondary | To evaluate safety of dosing regimens. | six months | No |
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