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

Phase 2 Open-Label Safety and Exploratory Skin Lesion Measurement Study of 6-Day Oral TR-701 FA in Skin Abscess and Cellulitis Patients

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

Study Overview

• Status: Completed
• Conditions: Cellulitis; Erysipelas; Major Cutaneous Abscess
• Intervention / Treatment: Drug: TR701 FA

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
• Enrollment (Actual): 200
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92804
      • Trius Investigator Site #118
    • Buena Park, California, United States, 90620
      • Trius Investigator Site #129
    • Chula Vista, California, United States, 91911
      • Trius Investigator Site 103
    • La Mesa, California, United States, 91942
      • Trius Investigator Site 105
    • Long Beach, California, United States, 90813
      • Trius Investigator Site #106
    • Oceanside, California, United States, 92056
      • Trius Investigator Site 104
  • Georgia
    • Columbus, Georgia, United States, 31904
      • Trius investigator site 101
    • Savannah, Georgia, United States, 31406
      • Trius Investigator Site 102
  • Nevada
    • Las Vegas, Nevada, United States, 89109
      • Trius investigator site 128
  • New Jersey
    • Somers Point, New Jersey, United States, 08244
      • Trius investigator site 115

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TR-701 FA	Drug: TR701 FA; 1 tablet 200 mg once daily; Other Names: Tedizolid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	24-31 days

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2012
• Primary Completion (Actual): August 27, 2012
• Study Completion (Actual): August 27, 2012

Study Registration Dates

• First Submitted: January 24, 2012
• First Submitted That Met QC Criteria: January 26, 2012
• First Posted (Estimate): January 27, 2012

Study Record Updates

• Last Update Posted (Actual): August 29, 2018
• Last Update Submitted That Met QC Criteria: July 31, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Infections; Inflammation; Connective Tissue Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases, Bacterial; Abscess; Cellulitis; Erysipelas; Anti-Infective Agents; Anti-Bacterial Agents; Tedizolid
• Other Study ID Numbers: 1986-011; TR701-126 (Other Identifier: TriusRX Unique ID)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf