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

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ClinicalTrials.gov Identifier: NCT01519778
Recruitment Status : Completed
First Posted : January 27, 2012
Results First Posted : March 12, 2015
Last Update Posted : June 14, 2018
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Trius Therapeutics LLC

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

Condition or disease Intervention/treatment Phase
Major Cutaneous Abscess Cellulitis Erysipelas Drug: TR701 FA Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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
Actual Study Start Date : February 15, 2012
Actual Primary Completion Date : August 27, 2012
Actual Study Completion Date : August 27, 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abscess Cellulitis

Arm Intervention/treatment
Experimental: TR-701 FA Drug: TR701 FA
1 tablet 200 mg once daily
Other Name: Tedizolid




Primary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
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 )
First Posted: January 27, 2012    Key Record Dates
Results First Posted: March 12, 2015
Last Update Posted: June 14, 2018
Last Verified: May 2018
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

URL: http://

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