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

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

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.

Study Overview

• Status: Completed
• Conditions: Skin Diseases, Infectious; Skin Diseases, Bacterial
• Intervention / Treatment: Drug: TR-701 200 mg; Drug: TR-701 300 mg; Drug: TR-701 400 mg

• Study Type: Interventional
• Enrollment (Actual): 192
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Dothan, Alabama, United States, 36301
      • Trius Study Site #011
  • California
    • Chula Vista, California, United States, 91911
      • Trius Study site #001
    • Long Beach, California, United States, 92708
      • Trius Study Site #009
    • Oceanside, California, United States, 92056
      • Trius Study site #002
    • Pasadena, California, United States, 91105
      • Trius Study site #010
    • San Francisco, California, United States, 94143
      • Trius Study site 007
    • San Jose, California, United States, 95124
      • Trius Study site 003
  • Georgia
    • Columbus, Georgia, United States, 31904
      • Trius Study site 004
    • Ludowici, Georgia, United States, 31316
      • Trius Study site #006
    • Savannah, Georgia, United States, 31406
      • Trius Study site #005
  • Illinois
    • Springfield, Illinois, United States, 62701
      • Trius Study site #012
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Trius study sie #008

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TR-701 200 mg	Drug: TR-701 200 mg; oral TR-701 200 mg for 5 to 7 days
Experimental: TR-701 300 mg	Drug: TR-701 300 mg; oral TR-701 300 mg for 5 to 7 days
Experimental: TR-701 400 mg	Drug: TR-701 400 mg; TR-701 400 mg for 5 to 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	7 to 14 days after the last dose of study drug
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.	7-14 days after last dose of study drug

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	last day of study treatment
Microbiological Response Rate at Test of Cure in the Microbiologically Evaluable Analysis Set	Satisfactory microbiological outcomes are eradication and presumed eradication	7-14 days after last dose of study drug
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.	21 to 28 days after the last study drug
To Evaluate the Safety Profile of Tedizolid Phosphate		Multiple
Population PK		Multiple
Microbiological Recurrence at Late Follow-up in Clinical Modified Intent to Treat Analysis Set		21-28 days after last study drug

Collaborators and Investigators

• Sponsor: Trius Therapeutics LLC
• Investigators: Study Chair: Philippe Prokocimer, MD, Trius

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2008
• Primary Completion (Actual): February 24, 2009
• Study Completion (Actual): February 24, 2009

Study Registration Dates

• First Submitted: September 25, 2008
• First Submitted That Met QC Criteria: September 26, 2008
• First Posted (Estimate): September 29, 2008

Study Record Updates

• Last Update Posted (Actual): November 25, 2019
• Last Update Submitted That Met QC Criteria: November 11, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Infection; Skin; Complicated Skin and Skin Structure Infection
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Skin Diseases, Infectious; Skin Diseases; Skin Diseases, Bacterial; Anti-Infective Agents; Anti-Bacterial Agents; Tedizolid phosphate
• Other Study ID Numbers: 1986-007; TR701-104 (Other Identifier: TriusRX Unique ID)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf