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

This study has been completed.
Sponsor:
Information provided by:
Trius Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00761215
First received: September 25, 2008
Last updated: June 8, 2009
Last verified: June 2009
  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 Structure Infections
Drug: oral TR-701
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 at the early follow-up visit [ Time Frame: 7 to 14 days after the last dose of study drug ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical outcome at the late follow-up visit [ Time Frame: 21 to 28 days after last dose of study drug ] [ Designated as safety issue: No ]
  • Microbiological response rates [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
  • Safety Profiles [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
  • Population pharmacokinetic profile of the study drug [ Time Frame: Day 3 and 5 while on study drug ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
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: A Drug: oral TR-701
TR-701 200 mg, 300 mg or 400 mg capsules once a day for 5 to 7 days
Experimental: B Drug: oral TR-701
TR-701 200 mg, 300 mg or 400 mg capsules once a day for 5 to 7 days
Experimental: C Drug: oral TR-701
TR-701 200 mg, 300 mg or 400 mg capsules once a day 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00761215

Locations
United States, Alabama
Dothan, Alabama, United States
United States, California
Chula Vista, California, United States
Long Beach, California, United States
Oceanside, California, United States
Pasadena, California, United States
San Francisco, California, United States
San Jose, California, United States
United States, Georgia
Columbus, Georgia, United States
Ludowici, Georgia, United States
Savannah, Georgia, United States
United States, Illinois
Springfield, Illinois, United States
United States, Michigan
Detroit, Michigan, United States
Sponsors and Collaborators
Trius Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: Philippe Prokocimer, MD, Chief Medical Officer, Trius Therapeutics
ClinicalTrials.gov Identifier: NCT00761215     History of Changes
Other Study ID Numbers: TR701-104
Study First Received: September 25, 2008
Last Updated: June 8, 2009
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

ClinicalTrials.gov processed this record on April 16, 2014