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 |
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.
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.
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
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