Phase 2 Study of TR-701 in Patients With Complicated Skin and Skin Structure Infections

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Trius Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00761215
First received: September 25, 2008
Last updated: August 8, 2014
Last verified: August 2014
  Purpose

The purpose of the study is to determine the oral dosage of TR-701 to be used in Phase III studies in patients with complicated skin and skin structure infections.


Condition Intervention Phase
Skin Diseases, Infectious
Skin Diseases, Bacterial
Drug: TR-701 200 mg
Drug: TR-701 300 mg
Drug: TR-701 400 mg
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Multi-Center, Randomized, Double-Blind, Non-Controlled Study Comparing the Safety, Tolerance, and Efficacy of TR-701 in Patients With Complicated Skin and Skin Structure Infections

Resource links provided by NLM:


Further study details as provided by Trius Therapeutics, Inc.:

Primary Outcome Measures:
  • Clinical Response Rate at Test of Cure in the Clinically Evaluable Analysis Set [ Time Frame: 7 to 14 days after the last dose of study drug ] [ Designated as safety issue: No ]
    Clinical response was defined as resolution or improvement of signs and symptoms of the complicated skin and skin structure infection so that no further antibiotic therapy was required.

  • Clinical Response Rate at Test of Cure in the Clinical Modified Intent to Treat Analysis Set [ Time Frame: 7-14 days after last dose of study drug ] [ Designated as safety issue: No ]
    Clinical response was defined as resolution or improvement of signs and symptoms of the complicated skin and skin structure infection so that no further antibiotic therapy was required.


Secondary Outcome Measures:
  • Response Rate at End of Therapy [ Time Frame: last day of study treatment ] [ Designated as safety issue: No ]
    Clinical response was defined as resolution or improvement of signs and symptoms of the complicated skin and skin structure infection so that no further antibiotic therapy was required.

  • Microbiological Response Rate at Test of Cure in the Microbiologically Evaluable Analysis Set [ Time Frame: 7-14 days after last dose of study drug ] [ Designated as safety issue: No ]
    Satisfactory microbiological outcomes are eradication and presumed eradication

  • Clinical Outcome at the Late Follow-up Visit in the Clinical Modified Intent to Treat Analysis Set [ Time Frame: 21 to 28 days after the last study drug ] [ Designated as safety issue: No ]
    Persistent clinical cure was defined as continuing favorable response.

  • To Evaluate the Safety Profile of Tedizolid Phosphate [ Time Frame: Multiple ] [ Designated as safety issue: Yes ]
  • Population PK [ Time Frame: Multiple ] [ Designated as safety issue: No ]
  • Microbiological Recurrence at Late Follow-up in Clinical Modified Intent to Treat Analysis Set [ Time Frame: 21-28 days after last study drug ] [ Designated as safety issue: No ]

Enrollment: 192
Study Start Date: September 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TR-701 200 mg
not applicable.
Drug: TR-701 200 mg
oral TR-701 200 mg for 5 to 7 days
Experimental: TR-701 300 mg
not applicable.
Drug: TR-701 300 mg
oral TR-701 300 mg for 5 to 7 days
Experimental: TR-701 400 mg
not applicable.
Drug: TR-701 400 mg
TR-701 400 mg for 5 to 7 days

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with complicated skin and skin structure infection with at least 2 signs and symptoms
  • Suspected or confirmed infection due to a gram-positive organism

Exclusion Criteria:

  • Complicated skin and skin structure infection due to gram-negative organisms
  • Complicated skin and skin structure infections requiring more than 7 days of therapy
  • Uncontrolled diabetes
  • Chronic systemic immunosuppressive therapy
  • AIDS with CD4 count < 200 cells/mm3
  • Uncontrolled hypertension
  • Mild moderate or severe renal failure
  • Severe hepatic disease
  • Neutropenia
  • Use of antidepressants such as SSRIs or MAOIs for 14 days before first dose of study drug
  • Women who are pregnant or nursing
  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: NCT00761215

Locations
United States, Alabama
Trius Study Site #011
Dothan, Alabama, United States, 36301
United States, California
Trius Study site #001
Chula Vista, California, United States, 91911
Trius Study Site #009
Long Beach, California, United States, 92708
Trius Study site #002
Oceanside, California, United States, 92056
Trius Study site #010
Pasadena, California, United States, 91105
Trius Study site 007
San Francisco, California, United States, 94143
Trius Study site 003
San Jose, California, United States, 95124
United States, Georgia
Trius Study site 004
Columbus, Georgia, United States, 31904
Trius Study site #006
Ludowici, Georgia, United States, 31316
Trius Study site #005
Savannah, Georgia, United States, 31406
United States, Illinois
Trius Study site #012
Springfield, Illinois, United States, 62701
United States, Michigan
Trius study sie #008
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Trius Therapeutics, Inc.
Investigators
Study Chair: Philippe Prokocimer, MD Trius
  More Information

No publications provided

Responsible Party: Trius Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00761215     History of Changes
Other Study ID Numbers: TR701-104
Study First Received: September 25, 2008
Results First Received: July 15, 2014
Last Updated: August 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Trius Therapeutics, Inc.:
Skin
Infection
Complicated Skin and Skin Structure Infection

Additional relevant MeSH terms:
Communicable Diseases
Infection
Skin Diseases
Skin Diseases, Infectious
Skin Diseases, Bacterial
Bacterial Infections

ClinicalTrials.gov processed this record on August 20, 2014