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

This study has been completed.
Sponsor:
Information provided by:
Targanta Therapeutics Corporation
ClinicalTrials.gov Identifier:
NCT00514527
First received: August 8, 2007
Last updated: August 13, 2008
Last verified: August 2008
  Purpose

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 Intervention Phase
Staphylococcal Skin Infections
Wounds and Injuries
Abscess
Cellulitis
Streptococcal Infections
Drug: oritavancin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by Targanta Therapeutics Corporation:

Primary Outcome Measures:
  • Clinical success at follow-up [ Time Frame: six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate safety of dosing regimens. [ Time Frame: six months ] [ Designated as safety issue: No ]

Estimated Enrollment: 294
Study Start Date: August 2007
Study Completion Date: May 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00514527

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

No publications provided

Responsible Party: Targanta Therapeutics Corporation
ClinicalTrials.gov Identifier: NCT00514527     History of Changes
Other Study ID Numbers: TAR-ORI-SD001
Study First Received: August 8, 2007
Last Updated: August 13, 2008
Health Authority: United States: Food and Drug Administration
Czech Republic: State Institute for Drug Control
India: Indian Council of Medical Research
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Romania: National Medicines Agency
Romania: State Institute for Drug Control
Ukraine: Ministry of Health
Ukraine: State Pharmacological Center - Ministry of Health
Australia: National Health and Medical Research Council
Spain: Comité Ético de Investigación Clínica

Additional relevant MeSH terms:
Cellulitis
Communicable Diseases
Infection
Skin Diseases, Infectious
Staphylococcal Skin Infections
Streptococcal Infections
Wounds and Injuries
Bacterial Infections
Connective Tissue Diseases
Gram-Positive Bacterial Infections
Inflammation
Pathologic Processes
Skin Diseases
Skin Diseases, Bacterial
Staphylococcal Infections
Suppuration

ClinicalTrials.gov processed this record on November 27, 2014