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Phase 2 Study of TR-701 in Patients With Complicated Skin and Skin Structure Infections

Primary Purpose

Skin Diseases, Infectious, Skin Diseases, Bacterial

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TR-701 200 mg
TR-701 300 mg
TR-701 400 mg
Sponsored by
Trius Therapeutics LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin Diseases, Infectious focused on measuring Skin, Infection, Complicated Skin and Skin Structure Infection

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed with complicated skin and skin structure infection with at least 2 signs and symptoms
  • Suspected or confirmed infection due to a gram-positive organism

Exclusion Criteria:

  • Complicated skin and skin structure infection due to gram-negative organisms
  • Complicated skin and skin structure infections requiring more than 7 days of therapy
  • Uncontrolled diabetes
  • Chronic systemic immunosuppressive therapy
  • AIDS with CD4 count < 200 cells/mm3
  • Uncontrolled hypertension
  • Mild moderate or severe renal failure
  • Severe hepatic disease
  • Neutropenia
  • Use of antidepressants such as SSRIs or MAOIs for 14 days before first dose of study drug
  • Women who are pregnant or nursing

Sites / Locations

  • Trius Study Site #011
  • Trius Study site #001
  • Trius Study Site #009
  • Trius Study site #002
  • Trius Study site #010
  • Trius Study site 007
  • Trius Study site 003
  • Trius Study site 004
  • Trius Study site #006
  • Trius Study site #005
  • Trius Study site #012
  • Trius study sie #008

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

TR-701 200 mg

TR-701 300 mg

TR-701 400 mg

Arm Description

Outcomes

Primary Outcome Measures

Clinical Response Rate at Test of Cure in the Clinically Evaluable Analysis Set
Clinical response was defined as resolution or improvement of signs and symptoms of the complicated skin and skin structure infection so that no further antibiotic therapy was required.
Clinical Response Rate at Test of Cure in the Clinical Modified Intent to Treat Analysis Set
Clinical response was defined as resolution or improvement of signs and symptoms of the complicated skin and skin structure infection so that no further antibiotic therapy was required.

Secondary Outcome Measures

Response Rate at End of Therapy
Clinical response was defined as resolution or improvement of signs and symptoms of the complicated skin and skin structure infection so that no further antibiotic therapy was required.
Microbiological Response Rate at Test of Cure in the Microbiologically Evaluable Analysis Set
Satisfactory microbiological outcomes are eradication and presumed eradication
Clinical Outcome at the Late Follow-up Visit in the Clinical Modified Intent to Treat Analysis Set
Persistent clinical cure was defined as continuing favorable response.
To Evaluate the Safety Profile of Tedizolid Phosphate
Population PK
Microbiological Recurrence at Late Follow-up in Clinical Modified Intent to Treat Analysis Set

Full Information

First Posted
September 25, 2008
Last Updated
November 11, 2019
Sponsor
Trius Therapeutics LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00761215
Brief Title
Phase 2 Study of TR-701 in Patients With Complicated Skin and Skin Structure Infections
Official Title
A Phase 2 Multi-Center, Randomized, Double-Blind, Non-Controlled Study Comparing the Safety, Tolerance, and Efficacy of TR-701 in Patients With Complicated Skin and Skin Structure Infections
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
September 17, 2008 (Actual)
Primary Completion Date
February 24, 2009 (Actual)
Study Completion Date
February 24, 2009 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to determine the oral dosage of TR-701 to be used in Phase III studies in patients with complicated skin and skin structure infections.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Diseases, Infectious, Skin Diseases, Bacterial
Keywords
Skin, Infection, Complicated Skin and Skin Structure Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
192 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TR-701 200 mg
Arm Type
Experimental
Arm Title
TR-701 300 mg
Arm Type
Experimental
Arm Title
TR-701 400 mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
TR-701 200 mg
Intervention Description
oral TR-701 200 mg for 5 to 7 days
Intervention Type
Drug
Intervention Name(s)
TR-701 300 mg
Intervention Description
oral TR-701 300 mg for 5 to 7 days
Intervention Type
Drug
Intervention Name(s)
TR-701 400 mg
Intervention Description
TR-701 400 mg for 5 to 7 days
Primary Outcome Measure Information:
Title
Clinical Response Rate at Test of Cure in the Clinically Evaluable Analysis Set
Description
Clinical response was defined as resolution or improvement of signs and symptoms of the complicated skin and skin structure infection so that no further antibiotic therapy was required.
Time Frame
7 to 14 days after the last dose of study drug
Title
Clinical Response Rate at Test of Cure in the Clinical Modified Intent to Treat Analysis Set
Description
Clinical response was defined as resolution or improvement of signs and symptoms of the complicated skin and skin structure infection so that no further antibiotic therapy was required.
Time Frame
7-14 days after last dose of study drug
Secondary Outcome Measure Information:
Title
Response Rate at End of Therapy
Description
Clinical response was defined as resolution or improvement of signs and symptoms of the complicated skin and skin structure infection so that no further antibiotic therapy was required.
Time Frame
last day of study treatment
Title
Microbiological Response Rate at Test of Cure in the Microbiologically Evaluable Analysis Set
Description
Satisfactory microbiological outcomes are eradication and presumed eradication
Time Frame
7-14 days after last dose of study drug
Title
Clinical Outcome at the Late Follow-up Visit in the Clinical Modified Intent to Treat Analysis Set
Description
Persistent clinical cure was defined as continuing favorable response.
Time Frame
21 to 28 days after the last study drug
Title
To Evaluate the Safety Profile of Tedizolid Phosphate
Time Frame
Multiple
Title
Population PK
Time Frame
Multiple
Title
Microbiological Recurrence at Late Follow-up in Clinical Modified Intent to Treat Analysis Set
Time Frame
21-28 days after last study drug

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with complicated skin and skin structure infection with at least 2 signs and symptoms Suspected or confirmed infection due to a gram-positive organism Exclusion Criteria: Complicated skin and skin structure infection due to gram-negative organisms Complicated skin and skin structure infections requiring more than 7 days of therapy Uncontrolled diabetes Chronic systemic immunosuppressive therapy AIDS with CD4 count < 200 cells/mm3 Uncontrolled hypertension Mild moderate or severe renal failure Severe hepatic disease Neutropenia Use of antidepressants such as SSRIs or MAOIs for 14 days before first dose of study drug Women who are pregnant or nursing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Prokocimer, MD
Organizational Affiliation
Trius
Official's Role
Study Chair
Facility Information:
Facility Name
Trius Study Site #011
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36301
Country
United States
Facility Name
Trius Study site #001
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Trius Study Site #009
City
Long Beach
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Trius Study site #002
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Trius Study site #010
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Trius Study site 007
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Trius Study site 003
City
San Jose
State/Province
California
ZIP/Postal Code
95124
Country
United States
Facility Name
Trius Study site 004
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Trius Study site #006
City
Ludowici
State/Province
Georgia
ZIP/Postal Code
31316
Country
United States
Facility Name
Trius Study site #005
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Trius Study site #012
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
Facility Name
Trius study sie #008
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
22687509
Citation
Prokocimer P, Bien P, Deanda C, Pillar CM, Bartizal K. In vitro activity and microbiological efficacy of tedizolid (TR-700) against Gram-positive clinical isolates from a phase 2 study of oral tedizolid phosphate (TR-701) in patients with complicated skin and skin structure infections. Antimicrob Agents Chemother. 2012 Sep;56(9):4608-13. doi: 10.1128/AAC.00458-12. Epub 2012 Jun 11.
Results Reference
result

Learn more about this trial

Phase 2 Study of TR-701 in Patients With Complicated Skin and Skin Structure Infections

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