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CompletedNCT00514527SIMPLIFIUpdated Aug 14, 2008

A Study for Patients With Complicated Skin and Skin Structure Infections

A Phase 2 interventional study of oritavancin in Staphylococcal Skin Infections, Wounds and Injuries and Abscess, sponsored by Targanta Therapeutics Corporation. Completed at 66 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-08-14.

Sponsored by Targanta Therapeutics Corporation · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
294
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Staphylococcal Skin Infections
  • Wounds and Injuries
  • Abscess
  • Cellulitis
  • Streptococcal Infections
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's planned enrollment of 294 is above the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

This is the only study on the registry with Targanta Therapeutics Corporation as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
294 participants (estimated)

Study arms

  • Experimental
    1

    Drug: oritavancin

  • Experimental
    2

    Drug: oritavancin

  • Experimental
    3

    Drug: oritavancin

Interventions

  • Drugoritavancin

    Oritavancin as a single, infrequent or daily dose.

06

What researchers measure

Primary outcomes

  1. Clinical success at follow-up

    Time frame: six months

Secondary outcomes

  1. To evaluate safety of dosing regimens.

    Time frame: six months

07

Study locations

66 sites
  • Targanta Recruiting Site
    Mobile, Alabama 36617, United States
  • Targanta Recruiting Site
    Anaheim, California 92804, United States
  • Targanta Recruiting Site
    Buena Park, California 90620, United States
  • Targanta Recruiting Site
    Chula Vista, California 91911, United States
  • Targanta Recruiting Site
    Hawaiian Gardens, California 90716, United States
  • Targanta Recruiting Site
    Long Beach, California 90813, United States
  • Targanta Recruiting Site
    Los Angeles, California 90015, United States
  • Targanta Recruiting Site
    Oceanside, California 92056, United States
  • Targanta Recruiting Site
    Rolling Hills Estates, California 90274, United States
  • Targanta Recruiting Site
    San Jose, California 95124, United States
  • Targanta Recruiting Site
    Torrance, California 90509, United States
  • Targanta Recruiting Site
    Atlantis, Florida 33462, United States
  • Targanta Recruiting Site
    Inverness, Florida 34452, United States
  • Targanta Recruiting Site
    Miami, Florida 33136, United States
  • Targanta Recruiting Site
    Columbus, Georgia 31405, United States
  • Targanta Recruiting Site
    Marietta, Georgia 30060, United States
  • Targanta Recruiting Site
    Savannah, Georgia 31405, United States
  • Targanta Recruiting Site
    Springfield, Illinois 602701, United States
  • Targanta Recruiting Site
    Indianapolis, Indiana 46280, United States
  • Targanta Recruiting Site
    Baton Rouge, Louisiana 70808, United States
  • Targanta Recruiting Site
    Lafayette, Louisiana 70503, United States
  • Targanta Recruiting Site
    New Orleans, Louisiana 70112, United States
  • Targanta Recruiting Site
    Cumberland, Maryland 21502, United States
  • Targanta Recruiting Site
    Detroit, Michigan 48202, United States
  • Targanta Recruiting Site
    Minneapolis, Minnesota 55422, United States
  • Targanta Recruiting Site
    Albany, New York 12208-1901, United States
  • Targanta Recruiting Site
    Columbus, Ohio 43215, United States
  • Targanta Recruiting Site
    Toledo, Ohio 43608, United States
  • Targanta Recruiting Site
    Jackson, Tennessee 38301, United States
  • Targanta Recruiting Site
    Arlington, Texas 76012, United States
  • Targanta Recruiting Site
    Houston, Texas 77005, United States
  • Targanta Recruiting Site
    Houston, Texas 77055, United States
  • Targanta Recruiting Site
    Salt Lake City, Utah 84102, United States
  • Targanta Recruiting Site
    Cairns, Queensland 4870, Australia
  • Targanta Recruiting Site
    Nambour, Queensland 4560, Australia
  • Targanta Recruiting Site
    Woolloongabba, Queensland 4102, Australia
  • Targanta Recruiting Site
    East Ringwood, Victoria 3135, Australia
  • Targanta Recruiting Site
    Parkville, Victoria 3050, Australia
  • Targanta Recruiting Site
    Fremantle, 6160, Australia
  • Targanta Recruiting Site
    Hyderabaad, Andhra Pradesh 500034, India
  • Targanta Recruiting Site
    Ahmedabad, Gujarat 380016, India
  • Targanta Recruiting Site
    Baroda, Gujarat 390 001, India
  • Targanta Recruiting Site
    Bangalore, Karnataka 560 002, India
  • Targanta Recruiting Site
    Bangalore, Karnataka 560 034, India
  • Targanta Recruiting Site
    Bangalore, Karnataka 560047, India
  • Targanta Recruiting Site
    Kochi, Kerala 682026, India
  • Targanta Recruiting Site
    Mumbai, Maharashtra 400 008, India
  • Targanta Recruiting Site
    Pune, Maharashtra 411004, India
  • Targanta Recruiting Site
    Lucknow, Uttar Pradesh 226003, India
  • Targanta Recruiting Site
    Catania, 95124, Italy
  • Targanta Recruiting Site
    Mantova, 46100, Italy
  • Targanta Recruiting Site
    Milano, 20122, Italy
  • Targanta Recruiting Site
    Pisa, 56126, Italy
  • Targanta Recruiting Site
    Savona, 17100, Italy
  • Targanta Recruiting Site
    Siena, 53100, Italy
  • Targanta Recruiting Site
    Bucharest, 50098, Romania
  • Targanta Recruiting Site
    Craiova, 01100, Romania
  • Targanta Recruiting Site
    Ivano-frankovsk, 07618, Ukraine
  • Targanta Recruiting Site
    Ivano-frankovsk, 76000, Ukraine
  • Targanta Recruiting Site
    Kharkov, 61001, Ukraine
  • Targanta Recruiting Site
    Kiev, 02094, Ukraine
  • Targanta Recruiting Site
    Kiev, 02125, Ukraine
  • Targanta Recruiting Site
    Kiev, 03039, Ukraine
  • Targanta Recruiting Site
    Odessa, 65025, Ukraine
  • Targanta Recruiting Site
    Ternopil, 46001, Ukraine
  • Targanta Recruiting Site
    Zaporizhzhya, 69032, Ukraine
08

References and documents

Publications

  • 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. PubMed 21537018 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00514527
Lead sponsor
Targanta Therapeutics Corporation
First posted
Aug 10, 2007
Start date
Aug 2007
Primary completion
Apr 2008
Completion
May 2008
Last update
Aug 14, 2008

Study contacts

Targanta Therapeutics
study director · simplifi@covance.com

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2008. You cannot join it, but the record below documents what was studied.

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