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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00761215
Other study ID # 1986-007
Secondary ID TR701-104
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


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
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