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

Sponsored by:	Trius Therapeutics, Inc.
Information provided by:	Trius Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT00761215

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 II

MedlinePlus related topics: Skin Conditions

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Uncontrolled, Parallel Assignment, Safety/Efficacy Study
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

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
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: oral TR-701 TR-701 200 mg, 300 mg or 400 mg capsules once a day for 5 to 7 days
B: Experimental	Drug: oral TR-701 TR-701 200 mg, 300 mg or 400 mg capsules once a day for 5 to 7 days
C: Experimental	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

Contacts

Contact: Paul Bien, MS

858-452-0370

Locations

United States, Alabama
	Not yet recruiting
Dothan, Alabama, United States
United States, California
	Recruiting
Chula Vista, California, United States
	Recruiting
Oceanside, California, United States
	Not yet recruiting
Long Beach, California, United States
	Not yet recruiting
San Francisco, California, United States
	Not yet recruiting
San Jose, California, United States
	Not yet recruiting
Pasadena, California, United States
United States, Georgia
	Recruiting
Columbus, Georgia, United States
	Recruiting
Savannah, Georgia, United States
	Active, not recruiting
Ludowici, Georgia, United States
United States, Illinois
	Not yet recruiting
Springfield, Illinois, United States
United States, Michigan
	Not yet recruiting
Detroit, Michigan, United States

Sponsors and Collaborators

Trius Therapeutics, Inc.

More Information

Responsible Party:	Trius Therapeutics ( Philippe Prokocimer, MD, Chief Medical Officer )
Study ID Numbers:	TR701-104
Study First Received:	September 25, 2008
Last Updated:	September 26, 2008
ClinicalTrials.gov Identifier:	NCT00761215
Health Authority:	United States: Food and Drug Administration

Keywords provided by Trius Therapeutics, Inc.:

Skin
Infection
Complicated Skin and Skin Structure Infection

Study placed in the following topic categories:

Skin Diseases, Infectious
Skin Diseases

Additional relevant MeSH terms:

Communicable Diseases
Infection

ClinicalTrials.gov processed this record on January 14, 2009