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

Study Overview
=================
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.

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

Conditions
-----------------
Skin Diseases, Infectious, Skin Diseases, Bacterial

Intervention / Treatment
-----------------
* Drug: TR-701 200 mg
* Drug: TR-701 300 mg
* Drug: TR-701 400 mg


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TR-701 200 mg<br> | Drug: TR-701 200 mg<br>* oral TR-701 200 mg for 5 to 7 days<br>|
| Experimental: TR-701 300 mg<br> | Drug: TR-701 300 mg<br>* oral TR-701 300 mg for 5 to 7 days<br>|
| Experimental: TR-701 400 mg<br> | Drug: TR-701 400 mg<br>* TR-701 400 mg for 5 to 7 days<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Skin, Infection, Complicated Skin and Skin Structure Infection