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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01519778
Other study ID # 1986-011
Secondary ID TR701-126
Status Completed
Phase Phase 2
First received
Last updated
Start date February 15, 2012
Est. completion date August 27, 2012

Study information

Verified date July 2018
Source Trius Therapeutics LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
TR701 FA
1 tablet 200 mg once daily

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Trius Therapeutics LLC Bayer

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

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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