A Study for Patients With Complicated Skin and Skin Structure Infections

NCT00514527 | Completed Phase 2

• 1 other identifier: TAR-ORI-SD001
• Study Type: interventional
• Target: 294
• Locations: 6 countries
• Sites: 66

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.

Conditions

Staphylococcal Skin Infections; Wounds and Injuries; Abscess; Cellulitis; Streptococcal Infections

Outcome Measures

Primary Outcomes (1)

• Clinical success at follow-up

  six months

Secondary Outcomes (1)

• To evaluate safety of dosing regimens.

  six months

Study Arms (3)

1

EXPERIMENTAL

Drug: oritavancin

2

EXPERIMENTAL

Drug: oritavancin

3

EXPERIMENTAL

Drug: oritavancin

Interventions

oritavancin DRUG

Oritavancin as a single, infrequent or daily dose.

1; 2; 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• toxic shock syndrome or toxic-like syndrome
• presumed or proven infection caused by Clostridium species
• bone infections
• ischemic or gangrenous ulcers or wounds
• infections caused only by gram-negative bacteria
• infection of an artificial joint that cannot be removed
• infection of the scrotum, perineum or perianal region
• infection of a severe burn wound

Sponsors & Collaborators

• Targanta Therapeutics Corporation: lead

Study Sites (66)

Targanta Recruiting Site

Mobile, Alabama, 36617, United States

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Anaheim, California, 92804, United States

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Buena Park, California, 90620, United States

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Chula Vista, California, 91911, United States

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Hawaiian Gardens, California, 90716, United States

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Long Beach, California, 90813, United States

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Los Angeles, California, 90015, United States

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Oceanside, California, 92056, United States

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Rolling Hills Estates, California, 90274, United States

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San Jose, California, 95124, United States

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Torrance, California, 90509, United States

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Atlantis, Florida, 33462, United States

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Inverness, Florida, 34452, United States

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Miami, Florida, 33136, United States

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Columbus, Georgia, 31405, United States

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Marietta, Georgia, 30060, United States

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Savannah, Georgia, 31405, United States

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Springfield, Illinois, 602701, United States

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Indianapolis, Indiana, 46280, United States

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Baton Rouge, Louisiana, 70808, United States

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Lafayette, Louisiana, 70503, United States

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New Orleans, Louisiana, 70112, United States

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Cumberland, Maryland, 21502, United States

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Detroit, Michigan, 48202, United States

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Minneapolis, Minnesota, 55422, United States

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Albany, New York, 12208-1901, United States

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Columbus, Ohio, 43215, United States

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Toledo, Ohio, 43608, United States

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Jackson, Tennessee, 38301, United States

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Arlington, Texas, 76012, United States

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Houston, Texas, 77005, United States

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Houston, Texas, 77055, United States

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Salt Lake City, Utah, 84102, United States

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Cairns, Queensland, 4870, Australia

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Nambour, Queensland, 4560, Australia

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Woolloongabba, Queensland, 4102, Australia

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East Ringwood, Victoria, 3135, Australia

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Parkville, Victoria, 3050, Australia

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Fremantle, 6160, Australia

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Hyderabaad, Andhra Pradesh, 500034, India

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Ahmedabad, Gujarat, 380016, India

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Vadodara, Gujarat, 390 001, India

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Bangalore, Karnataka, 560 002, India

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Bangalore, Karnataka, 560 034, India

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Bangalore, Karnataka, 560047, India

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Kochi, Kerala, 682026, India

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Mumbai, Maharashtra, 400 008, India

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Pune, Maharashtra, 411004, India

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Lucknow, Uttar Pradesh, 226003, India

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Catania, 95124, Italy

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Mantova, 46100, Italy

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Milan, 20122, Italy

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Pisa, 56126, Italy

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Savona, 17100, Italy

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Siena, 53100, Italy

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Bucharest, 50098, Romania

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Craiova, 01100, Romania

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Ivano-Frankivsk, 07618, Ukraine

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Ivano-Frankivsk, 76000, Ukraine

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Kharkiv, 61001, Ukraine

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Kiev, 02094, Ukraine

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Kiev, 02125, Ukraine

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Kiev, 03039, Ukraine

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Odesa, 65025, Ukraine

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Ternopil, 46001, Ukraine

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Zaporizhzhya, 69032, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 21537018 DERIVED

MeSH Terms

Conditions

Staphylococcal Skin Infections; Wounds and Injuries; Abscess; Cellulitis; Streptococcal Infections

Interventions

oritavancin

Condition Hierarchy (Ancestors)

Staphylococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Bacterial; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Suppuration; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Connective Tissue Diseases

Study Officials

• Targanta Therapeutics

  simplifi@covance.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 8, 2007
• First Posted: August 10, 2007
• Study Start: August 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: May 1, 2008
• Last Updated: August 14, 2008

Record last verified: 2008-08

Locations

AU (6); RO (2); US (33); IT (6); UA (9); IN (10)