Phase 2 Study of TR-701 in Patients With Complicated Skin and Skin Structure Infections
This study has been completed.
Sponsor:
Trius Therapeutics, Inc.
Information provided by:
Trius Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00761215
First received: September 25, 2008
Last updated: June 8, 2009
Last verified: June 2009
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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 May 16, 2013