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

Skin Diseases, Infectious Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00761215
• Other study ID #: 1986-007
• Secondary ID: TR701-104
• Status: Completed
• Phase: Phase 2
• Start date: September 17, 2008
• Est. completion date: February 24, 2009

Study information

• Verified date: November 2019
• Source: Trius Therapeutics LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: February 24, 2009
• Est. primary completion date: February 24, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Skin Diseases
• Skin Diseases, Bacterial
• Skin Diseases, Infectious

Intervention

Drug:
• TR-701 200 mg
oral TR-701 200 mg for 5 to 7 days
• TR-701 300 mg
oral TR-701 300 mg for 5 to 7 days
• TR-701 400 mg
TR-701 400 mg for 5 to 7 days

Locations

Country	Name	City	State
United States	Trius Study site #001	Chula Vista	California
United States	Trius Study site 004	Columbus	Georgia
United States	Trius study sie #008	Detroit	Michigan
United States	Trius Study Site #011	Dothan	Alabama
United States	Trius Study Site #009	Long Beach	California
United States	Trius Study site #006	Ludowici	Georgia
United States	Trius Study site #002	Oceanside	California
United States	Trius Study site #010	Pasadena	California
United States	Trius Study site 007	San Francisco	California
United States	Trius Study site 003	San Jose	California
United States	Trius Study site #005	Savannah	Georgia
United States	Trius Study site #012	Springfield	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Trius Therapeutics LLC

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	To Evaluate the Safety Profile of Tedizolid Phosphate		Multiple
Secondary	Population PK		Multiple
Secondary	Microbiological Recurrence at Late Follow-up in Clinical Modified Intent to Treat Analysis Set		21-28 days after last study drug