A Study for Patients With Complicated Skin and Skin Structure Infections (SIMPLIFI)

August 13, 2008 updated by: Targanta Therapeutics Corporation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

294

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: oritavancin
Oritavancin as a single, infrequent or daily dose.
Experimental: 2
Drug: oritavancin
Oritavancin as a single, infrequent or daily dose.
Experimental: 3
Drug: oritavancin
Oritavancin as a single, infrequent or daily dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical success at follow-up
Time Frame: six months
six months

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate safety of dosing regimens.
Time Frame: six months
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Targanta Therapeutics Corporation

Investigators

  • Study Director: Targanta Therapeutics, simplifi@covance.com

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

August 8, 2007

First Submitted That Met QC Criteria

August 8, 2007

First Posted (Estimate)

August 10, 2007

Study Record Updates

Last Update Posted (Estimate)

August 14, 2008

Last Update Submitted That Met QC Criteria

August 13, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAR-ORI-SD001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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