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A Phase 2 Safety and Exploratory Skin Lesion Measurement of TR-701 FA Study

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Trius Therapeutics LLC
ClinicalTrials.gov Identifier:
NCT01519778
First received: January 24, 2012
Last updated: March 21, 2017
Last verified: March 2017
  Purpose
Characterization of the safety profile of TR-701 Free Acid (FA) in patients with major cutaneous abscess or cellulitis/erysipelas.

Condition Intervention Phase
Major Cutaneous Abscess Cellulitis Erysipelas Drug: TR701 FA Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Other
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

Resource links provided by NLM:


Further study details as provided by Trius Therapeutics LLC:

Primary Outcome Measures:
  • Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 24-31 days ]
    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).


Enrollment: 200
Actual Study Start Date: February 1, 2012
Study Completion Date: August 1, 2012
Primary Completion Date: August 1, 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TR-701 FA Drug: TR701 FA
1 tablet 200 mg once daily
Other Name: Tedizolid

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01519778

Locations
United States, California
Trius Investigator Site #118
Anaheim, California, United States, 92804
Trius Investigator Site #129
Buena Park, California, United States, 90620
Trius Investigator Site 103
Chula Vista, California, United States, 91911
Trius Investigator Site 105
La Mesa, California, United States, 91942
Trius Investigator Site #106
Long Beach, California, United States, 90813
Trius Investigator Site 104
Oceanside, California, United States, 92056
United States, Georgia
Trius Investigator Site 101
Columbus, Georgia, United States, 31904
Trius Investigator Site 102
Savannah, Georgia, United States, 31406
United States, Nevada
Trius Investigator Site 128
Las Vegas,, Nevada, United States, 89109
United States, New Jersey
Trius Investigator Site 115
Somers Point, New Jersey, United States, 08244
Sponsors and Collaborators
Trius Therapeutics LLC
Bayer
Investigators
Study Chair: Philippe Prokocimer, MD Trius Therapeutics
  More Information

Publications:
Responsible Party: Trius Therapeutics LLC
ClinicalTrials.gov Identifier: NCT01519778     History of Changes
Other Study ID Numbers: 1986-011
TR701-126 ( Other Identifier: TriusRX Unique ID )
Study First Received: January 24, 2012
Results First Received: February 27, 2015
Last Updated: March 21, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php


Additional relevant MeSH terms:
Abscess
Cellulitis
Erysipelas
Suppuration
Infection
Inflammation
Pathologic Processes
Skin Diseases, Infectious
Connective Tissue Diseases
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Skin Diseases, Bacterial
Skin Diseases
Torezolid phosphate
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on July 21, 2017