Clinical trial NCT00514527: A Study for Patients With Complicated Skin and Skin Structure Infections
Official title: Nuvocid® (Oritavancin) at Single or Infrequent Doses for the Treatment of Complicated Skin and Skin Structure Infections (SIMPLIFI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Staphylococcal Skin Infections
Wounds and Injuries
Abscess
Cellulitis
Streptococcal Infections
Lead sponsor: Targanta Therapeutics Corporation
Sponsor class: INDUSTRY
First posted: 2007-08-10
Enrollment: 294
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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:

  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

Primary outcomes:
measure: Clinical success at follow-up
timeFrame: six months
Secondary outcomes:
measure: To evaluate safety of dosing regimens.
timeFrame: six months
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Targanta Recruiting Site
state: Alabama
city: Anaheim
country: United States
facility: Targanta Recruiting Site
state: California
city: Buena Park
country: United States
facility: Targanta Recruiting Site
state: California
city: Chula Vista
country: United States
facility: Targanta Recruiting Site
state: California
city: Hawaiian Gardens
country: United States
facility: Targanta Recruiting Site
state: California
city: Long Beach
country: United States
facility: Targanta Recruiting Site
state: California
city: Los Angeles
country: United States
facility: Targanta Recruiting Site
state: California
city: Oceanside
country: United States
facility: Targanta Recruiting Site
state: California
city: Rolling Hills Estates
country: United States
facility: Targanta Recruiting Site
state: California
city: San Jose
country: United States
facility: Targanta Recruiting Site
state: California
city: Torrance
country: United States
facility: Targanta Recruiting Site
state: California
city: Atlantis
country: United States
facility: Targanta Recruiting Site
state: Florida
city: Inverness
country: United States
facility: Targanta Recruiting Site
state: Florida
city: Miami
country: United States
facility: Targanta Recruiting Site
state: Florida
city: Columbus
country: United States
facility: Targanta Recruiting Site
state: Georgia
city: Marietta
country: United States
facility: Targanta Recruiting Site
state: Georgia
city: Savannah
country: United States
facility: Targanta Recruiting Site
state: Georgia
city: Springfield
country: United States
facility: Targanta Recruiting Site
state: Illinois
city: Indianapolis
country: United States
facility: Targanta Recruiting Site
state: Indiana
city: Baton Rouge
country: United States
facility: Targanta Recruiting Site
state: Louisiana
city: Lafayette
country: United States
facility: Targanta Recruiting Site
state: Louisiana
city: New Orleans
country: United States
facility: Targanta Recruiting Site
state: Louisiana
city: Cumberland
country: United States
facility: Targanta Recruiting Site
state: Maryland
city: Detroit
country: United States
facility: Targanta Recruiting Site
state: Michigan
city: Minneapolis
country: United States
facility: Targanta Recruiting Site
state: Minnesota
city: Albany
country: United States
facility: Targanta Recruiting Site
state: New York
city: Columbus
country: United States
facility: Targanta Recruiting Site
state: Ohio
city: Toledo
country: United States
facility: Targanta Recruiting Site
state: Ohio
city: Jackson
country: United States
facility: Targanta Recruiting Site
state: Tennessee
city: Arlington
country: United States
facility: Targanta Recruiting Site
state: Texas
city: Houston
country: United States
facility: Targanta Recruiting Site
state: Texas
city: Houston
country: United States
facility: Targanta Recruiting Site
state: Texas
city: Salt Lake City
country: United States
facility: Targanta Recruiting Site
state: Utah
city: Cairns
country: Australia
facility: Targanta Recruiting Site
state: Queensland
city: Nambour
country: Australia
facility: Targanta Recruiting Site
state: Queensland
city: Woolloongabba
country: Australia
facility: Targanta Recruiting Site
state: Queensland
city: East Ringwood
country: Australia
facility: Targanta Recruiting Site
state: Victoria
city: Parkville
country: Australia
facility: Targanta Recruiting Site
state: Victoria
city: Fremantle
country: Australia
facility: Targanta Recruiting Site
city: Hyderabaad
country: India
facility: Targanta Recruiting Site
state: Andhra Pradesh
city: Ahmedabad
country: India
facility: Targanta Recruiting Site
state: Gujarat
city: Baroda
country: India
facility: Targanta Recruiting Site
state: Gujarat
city: Bangalore
country: India
facility: Targanta Recruiting Site
state: Karnataka
city: Bangalore
country: India
facility: Targanta Recruiting Site
state: Karnataka
city: Bangalore
country: India
facility: Targanta Recruiting Site
state: Karnataka
city: Kochi
country: India
facility: Targanta Recruiting Site
state: Kerala
city: Mumbai
country: India
facility: Targanta Recruiting Site
state: Maharashtra
city: Pune
country: India
facility: Targanta Recruiting Site
state: Maharashtra
city: Lucknow
country: India
facility: Targanta Recruiting Site
state: Uttar Pradesh
city: Catania
country: Italy
facility: Targanta Recruiting Site
city: Mantova
country: Italy
facility: Targanta Recruiting Site
city: Milano
country: Italy
facility: Targanta Recruiting Site
city: Pisa
country: Italy
facility: Targanta Recruiting Site
city: Savona
country: Italy
facility: Targanta Recruiting Site
city: Siena
country: Italy
facility: Targanta Recruiting Site
city: Bucharest
country: Romania
facility: Targanta Recruiting Site
city: Craiova
country: Romania
facility: Targanta Recruiting Site
city: Ivano-frankovsk
country: Ukraine
facility: Targanta Recruiting Site
city: Ivano-frankovsk
country: Ukraine
facility: Targanta Recruiting Site
city: Kharkov
country: Ukraine
facility: Targanta Recruiting Site
city: Kiev
country: Ukraine
facility: Targanta Recruiting Site
city: Kiev
country: Ukraine
facility: Targanta Recruiting Site
city: Kiev
country: Ukraine
facility: Targanta Recruiting Site
city: Odessa
country: Ukraine
facility: Targanta Recruiting Site
city: Ternopil
country: Ukraine
facility: Targanta Recruiting Site
city: Zaporizhzhya
country: Ukraine
facility: Targanta Recruiting Site
Study officials:
affiliation: simplifi@covance.com
name: Targanta Therapeutics
role: STUDY_DIRECTOR
References:
citation: Dunbar LM, Milata J, McClure T, Wasilewski MM; SIMPLIFI Study Team. Comparison of the efficacy and safety of oritavancin front-loaded dosing regimens to daily dosing: an analysis of the SIMPLIFI trial. Antimicrob Agents Chemother. 2011 Jul;55(7):3476-84. doi: 10.1128/AAC.00029-11. Epub 2011 May 2.