Phase 2 Study of TR-701 in Patients With Complicated Skin and Skin Structure Infections
NCT ID: NCT00761215
Last Updated: 2019-11-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
192 participants
INTERVENTIONAL
2008-09-17
2009-02-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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TR-701 200 mg
TR-701 200 mg
oral TR-701 200 mg for 5 to 7 days
TR-701 300 mg
TR-701 300 mg
oral TR-701 300 mg for 5 to 7 days
TR-701 400 mg
TR-701 400 mg
TR-701 400 mg for 5 to 7 days
Interventions
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TR-701 200 mg
oral TR-701 200 mg for 5 to 7 days
TR-701 300 mg
oral TR-701 300 mg for 5 to 7 days
TR-701 400 mg
TR-701 400 mg for 5 to 7 days
Eligibility Criteria
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Inclusion Criteria
* Suspected or confirmed infection due to a gram-positive organism
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
INDUSTRY
Responsible Party
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Principal Investigators
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Philippe Prokocimer, MD
Role: STUDY_CHAIR
Trius
Locations
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Trius Study Site #011
Dothan, Alabama, United States
Trius Study site #001
Chula Vista, California, United States
Trius Study Site #009
Long Beach, California, United States
Trius Study site #002
Oceanside, California, United States
Trius Study site #010
Pasadena, California, United States
Trius Study site 007
San Francisco, California, United States
Trius Study site 003
San Jose, California, United States
Trius Study site 004
Columbus, Georgia, United States
Trius Study site #006
Ludowici, Georgia, United States
Trius Study site #005
Savannah, Georgia, United States
Trius Study site #012
Springfield, Illinois, United States
Trius study sie #008
Detroit, Michigan, United States
Countries
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References
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Prokocimer P, Bien P, Deanda C, Pillar CM, Bartizal K. In vitro activity and microbiological efficacy of tedizolid (TR-700) against Gram-positive clinical isolates from a phase 2 study of oral tedizolid phosphate (TR-701) in patients with complicated skin and skin structure infections. Antimicrob Agents Chemother. 2012 Sep;56(9):4608-13. doi: 10.1128/AAC.00458-12. Epub 2012 Jun 11.
Other Identifiers
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TR701-104
Identifier Type: OTHER
Identifier Source: secondary_id
1986-007
Identifier Type: -
Identifier Source: org_study_id
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