Cellulitis Clinical Trial
Official title:
Phase 2 Open-Label Safety and Exploratory Skin Lesion Measurement Study of 6-Day Oral TR-701 FA in Skin Abscess and Cellulitis Patients
Verified date | July 2018 |
Source | Trius Therapeutics LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Characterization of the safety profile of TR-701 Free Acid (FA) in patients with major cutaneous abscess or cellulitis/erysipelas.
Status | Completed |
Enrollment | 200 |
Est. completion date | August 27, 2012 |
Est. primary completion date | August 27, 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | 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 101 | Columbus | Georgia |
United States | Trius Investigator Site 105 | La Mesa | California |
United States | Trius Investigator Site 128 | Las Vegas | Nevada |
United States | Trius Investigator Site #106 | Long Beach | California |
United States | Trius Investigator Site 104 | Oceanside | California |
United States | Trius Investigator Site 102 | Savannah | Georgia |
United States | Trius Investigator Site 115 | Somers Point | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Trius Therapeutics LLC | Bayer |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Safety will be assessed through summaries of the incidence of AEs and SAEs as well as through summaries of vital signs, physical examinations, ECG findings, and laboratory assessments (hematology, serum chemistry, and urinalysis). | 24-31 days |
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