Clinical trial NCT01519778: A Phase 2 Safety and Exploratory Skin Lesion Measurement of TR-701 FA Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Cutaneous Abscess
Cellulitis
Erysipelas
Lead sponsor: Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Sponsor class: INDUSTRY
Collaborators: name: Bayer
First posted: 2012-01-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: 24-31 days
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Trius Investigator Site #118
state: California
city: Buena Park
country: United States
facility: Trius Investigator Site #129
state: California
city: Chula Vista
country: United States
facility: Trius Investigator Site 103
state: California
city: La Mesa
country: United States
facility: Trius Investigator Site 105
state: California
city: Long Beach
country: United States
facility: Trius Investigator Site #106
state: California
city: Oceanside
country: United States
facility: Trius Investigator Site 104
state: California
city: Columbus
country: United States
facility: Trius Investigator Site 101
state: Georgia
city: Savannah
country: United States
facility: Trius Investigator Site 102
state: Georgia
city: Las Vegas
country: United States
facility: Trius Investigator Site 128
state: Nevada
city: Somers Point
country: United States
facility: Trius Investigator Site 115
state: New Jersey
Study officials:
affiliation: Trius Therapeutics
name: Philippe Prokocimer, MD
role: STUDY_CHAIR
References:
citation: 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.