Clinical trial NCT00761215: Phase 2 Study of TR-701 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Skin Diseases, Infectious
Skin Diseases, Bacterial
Keywords: Skin
Infection
Complicated Skin and Skin Structure Infection
Lead sponsor: Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Sponsor class: INDUSTRY
First posted: 2008-09-29
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Clinical Response Rate at Test of Cure in the Clinically Evaluable Analysis Set
timeFrame: 7 to 14 days after the last dose of study drug
measure: Clinical Response Rate at Test of Cure in the Clinical Modified Intent to Treat Analysis Set
timeFrame: 7-14 days after last dose of study drug
Secondary outcomes:
measure: Response Rate at End of Therapy
timeFrame: last day of study treatment
measure: Microbiological Response Rate at Test of Cure in the Microbiologically Evaluable Analysis Set
timeFrame: 7-14 days after last dose of study drug
measure: Clinical Outcome at the Late Follow-up Visit in the Clinical Modified Intent to Treat Analysis Set
timeFrame: 21 to 28 days after the last study drug
measure: To Evaluate the Safety Profile of Tedizolid Phosphate
timeFrame: Multiple
measure: Population PK
timeFrame: Multiple
measure: Microbiological Recurrence at Late Follow-up in Clinical Modified Intent to Treat Analysis Set
timeFrame: 21-28 days after last study drug
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Trius Study Site #011
state: Alabama
city: Chula Vista
country: United States
facility: Trius Study site #001
state: California
city: Long Beach
country: United States
facility: Trius Study Site #009
state: California
city: Oceanside
country: United States
facility: Trius Study site #002
state: California
city: Pasadena
country: United States
facility: Trius Study site #010
state: California
city: San Francisco
country: United States
facility: Trius Study site 007
state: California
city: San Jose
country: United States
facility: Trius Study site 003
state: California
city: Columbus
country: United States
facility: Trius Study site 004
state: Georgia
city: Ludowici
country: United States
facility: Trius Study site #006
state: Georgia
city: Savannah
country: United States
facility: Trius Study site #005
state: Georgia
city: Springfield
country: United States
facility: Trius Study site #012
state: Illinois
city: Detroit
country: United States
facility: Trius study sie #008
state: Michigan
Study officials:
affiliation: Trius
name: Philippe Prokocimer, MD
role: STUDY_CHAIR
References:
citation: 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.