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

Primary Purpose

Major Cutaneous Abscess, Cellulitis, Erysipelas

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TR701 FA
Sponsored by
Trius Therapeutics LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Major Cutaneous Abscess

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Trius Investigator Site #118
  • Trius Investigator Site #129
  • Trius Investigator Site 103
  • Trius Investigator Site 105
  • Trius Investigator Site #106
  • Trius Investigator Site 104
  • Trius Investigator Site 101
  • Trius Investigator Site 102
  • Trius Investigator Site 128
  • Trius Investigator Site 115

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TR-701 FA

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
January 24, 2012
Last Updated
July 31, 2018
Sponsor
Trius Therapeutics LLC
Collaborators
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT01519778
Brief Title
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

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
February 15, 2012 (Actual)
Primary Completion Date
August 27, 2012 (Actual)
Study Completion Date
August 27, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Trius Therapeutics LLC
Collaborators
Bayer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Cutaneous Abscess, Cellulitis, Erysipelas

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TR-701 FA
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
TR701 FA
Other Intervention Name(s)
Tedizolid
Intervention Description
1 tablet 200 mg once daily
Primary Outcome Measure Information:
Title
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
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).
Time Frame
24-31 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Prokocimer, MD
Organizational Affiliation
Trius Therapeutics
Official's Role
Study Chair
Facility Information:
Facility Name
Trius Investigator Site #118
City
Anaheim
State/Province
California
ZIP/Postal Code
92804
Country
United States
Facility Name
Trius Investigator Site #129
City
Buena Park
State/Province
California
ZIP/Postal Code
90620
Country
United States
Facility Name
Trius Investigator Site 103
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Trius Investigator Site 105
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Trius Investigator Site #106
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
Trius Investigator Site 104
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Trius Investigator Site 101
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Trius Investigator Site 102
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Trius Investigator Site 128
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Trius Investigator Site 115
City
Somers Point
State/Province
New Jersey
ZIP/Postal Code
08244
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
27530088
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.
Results Reference
result

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

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