A Phase 2 Safety and Exploratory Skin Lesion Measurement of TR-701 FA Study
NCT ID: NCT01519778
Last Updated: 2018-08-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
200 participants
INTERVENTIONAL
2012-02-15
2012-08-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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TR-701 FA
TR701 FA
1 tablet 200 mg once daily
Interventions
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TR701 FA
1 tablet 200 mg once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Suspected or documented gram-positive infection from baseline Gram stain or culture.
* Cellulitis/erysipelas or major cutaneous abscesses at Screening
Exclusion Criteria
* Severe sepsis or septic shock
* Uncomplicated skin and skin structure infections such as furuncles, minor abscesses (\< 75 cm2 or area of suppuration not surrounded by cellulitis/erythema), and impetiginous lesions
* Infections associated with, or in close proximity to, a prosthetic device
* Known bacteremia or osteomyelitis at time of screening
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
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 Therapeutics
Locations
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Trius Investigator Site #118
Anaheim, California, United States
Trius Investigator Site #129
Buena Park, California, United States
Trius Investigator Site 103
Chula Vista, California, United States
Trius Investigator Site 105
La Mesa, California, United States
Trius Investigator Site #106
Long Beach, California, United States
Trius Investigator Site 104
Oceanside, California, United States
Trius Investigator Site 101
Columbus, Georgia, United States
Trius Investigator Site 102
Savannah, Georgia, United States
Trius Investigator Site 128
Las Vegas, Nevada, United States
Trius Investigator Site 115
Somers Point, New Jersey, United States
Countries
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References
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Powers JH 3rd, Das AF, De Anda C, Prokocimer P. Clinician-reported lesion measurements in skin infection trials: Definitions, reliability, and association with patient-reported pain. Contemp Clin Trials. 2016 Sep;50:265-72. doi: 10.1016/j.cct.2016.08.010. Epub 2016 Aug 13.
Other Identifiers
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TR701-126
Identifier Type: OTHER
Identifier Source: secondary_id
1986-011
Identifier Type: -
Identifier Source: org_study_id
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