Status:
COMPLETED
A Phase 2 Safety and Exploratory Skin Lesion Measurement of TR-701 FA Study
Lead Sponsor:
Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Collaborating Sponsors:
Bayer
Conditions:
Major Cutaneous Abscess
Cellulitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Characterization of the safety profile of TR-701 Free Acid (FA) in patients with major cutaneous abscess or cellulitis/erysipelas.
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 15 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 27 2012
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01519778
Start Date
February 15 2012
End Date
August 27 2012
Last Update
August 29 2018
Active Locations (10)
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1
Trius Investigator Site #118
Anaheim, California, United States, 92804
2
Trius Investigator Site #129
Buena Park, California, United States, 90620
3
Trius Investigator Site 103
Chula Vista, California, United States, 91911
4
Trius Investigator Site 105
La Mesa, California, United States, 91942