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

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ClinicalTrials.gov Identifier: NCT00514527
Recruitment Status : Completed
First Posted : August 10, 2007
Last Update Posted : August 14, 2008
Information provided by:
Targanta Therapeutics Corporation

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.

Condition or disease Intervention/treatment Phase
Staphylococcal Skin Infections Wounds and Injuries Abscess Cellulitis Streptococcal Infections Drug: oritavancin Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 294 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nuvocid® (Oritavancin) at Single or Infrequent Doses for the Treatment of Complicated Skin and Skin Structure Infections (SIMPLIFI)
Study Start Date : August 2007
Primary Completion Date : April 2008
Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Oritavancin
U.S. FDA Resources

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.

Primary Outcome Measures :
  1. Clinical success at follow-up [ Time Frame: six months ]

Secondary Outcome Measures :
  1. To evaluate safety of dosing regimens. [ Time Frame: six months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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:


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00514527

  Show 66 Study Locations
Sponsors and Collaborators
Targanta Therapeutics Corporation
Study Director: Targanta Therapeutics simplifi@covance.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Targanta Therapeutics Corporation
ClinicalTrials.gov Identifier: NCT00514527     History of Changes
Other Study ID Numbers: TAR-ORI-SD001
First Posted: August 10, 2007    Key Record Dates
Last Update Posted: August 14, 2008
Last Verified: August 2008

Additional relevant MeSH terms:
Communicable Diseases
Wounds and Injuries
Skin Diseases, Infectious
Streptococcal Infections
Staphylococcal Skin Infections
Skin Diseases
Connective Tissue Diseases
Pathologic Processes
Gram-Positive Bacterial Infections
Bacterial Infections
Staphylococcal Infections
Skin Diseases, Bacterial
Anti-Bacterial Agents
Anti-Infective Agents