A Phase 2 Safety and Exploratory Skin Lesion Measurement of TR-701 FA Study



Status:Completed
Conditions:Skin and Soft Tissue Infections, Cosmetic
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:8/31/2018
Start Date:February 15, 2012
End Date:August 27, 2012

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Phase 2 Open-Label Safety and Exploratory Skin Lesion Measurement Study of 6-Day Oral TR-701 FA in Skin Abscess and Cellulitis Patients

Characterization of the safety profile of TR-701 Free Acid (FA) in patients with major
cutaneous abscess or cellulitis/erysipelas.

This is an open-label, multicenter study of oral TR-701 FA 200 mg once daily for 6 days for
the treatment of major cutaneous abscess or cellulitis/erysipelas in patients 18 years of age
or older. This study is designed to further characterize the safety profile and gather
additional lesion measurement data of TR-701 FA in patients with major cutaneous abscess or
cellulitis/erysipelas.

Inclusion Criteria:

- Male or female patients ≥ 18 years of age

- Suspected or documented gram-positive infection from baseline Gram stain or culture.

- Cellulitis/erysipelas or major cutaneous abscesses at Screening

Exclusion Criteria:

- Postsurgical or open wound infections

- 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
We found this trial at
10
sites
Savannah, Georgia 31406
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Savannah, GA
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Anaheim, California 92801
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Anaheim, CA
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Buena Park, California 90620
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Buena Park, CA
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Chula Vista, California 91911
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Chula Vista, CA
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Columbus, Georgia 31904
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Columbus, GA
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La Mesa, California 91942
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La Mesa, CA
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Las Vegas, Nevada 89169
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Las Vegas, NV
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Long Beach, California 90813
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Long Beach, CA
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Oceanside, California 92056
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Oceanside, CA
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Somers Point, New Jersey 08244
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Somers Point, NJ
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