Phase 2 Study of TR-701 in Patients With Complicated Skin and Skin Structure Infections
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
2 other identifiers
interventional
192
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2008
Shorter than P25 for phase_2
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 17, 2008
CompletedFirst Submitted
Initial submission to the registry
September 25, 2008
CompletedFirst Posted
Study publicly available on registry
September 29, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 24, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 24, 2009
CompletedResults Posted
Study results publicly available
August 7, 2014
CompletedNovember 25, 2019
November 1, 2019
5 months
September 25, 2008
July 15, 2014
November 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (6)
Response Rate at End of Therapy
last day of study treatment
Microbiological Response Rate at Test of Cure in the Microbiologically Evaluable Analysis Set
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
21 to 28 days after the last study drug
To Evaluate the Safety Profile of Tedizolid Phosphate
Multiple
Population PK
Multiple
- +1 more secondary outcomes
Study Arms (3)
TR-701 200 mg
EXPERIMENTALTR-701 300 mg
EXPERIMENTALTR-701 400 mg
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Trius Study Site #011
Dothan, Alabama, 36301, United States
Trius Study site #001
Chula Vista, California, 91911, United States
Trius Study Site #009
Long Beach, California, 92708, United States
Trius Study site #002
Oceanside, California, 92056, United States
Trius Study site #010
Pasadena, California, 91105, United States
Trius Study site 007
San Francisco, California, 94143, United States
Trius Study site 003
San Jose, California, 95124, United States
Trius Study site 004
Columbus, Georgia, 31904, United States
Trius Study site #006
Ludowici, Georgia, 31316, United States
Trius Study site #005
Savannah, Georgia, 31406, United States
Trius Study site #012
Springfield, Illinois, 62701, United States
Trius study sie #008
Detroit, Michigan, 48202, United States
Related 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 and skin structure infections. Antimicrob Agents Chemother. 2012 Sep;56(9):4608-13. doi: 10.1128/AAC.00458-12. Epub 2012 Jun 11.
PMID: 22687509RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Philippe Prokocimer, MD
- Organization
- Cubist Pharmaceuticals, Inc.
Study Officials
- STUDY CHAIR
Philippe Prokocimer, MD
Trius
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2008
First Posted
September 29, 2008
Study Start
September 17, 2008
Primary Completion
February 24, 2009
Study Completion
February 24, 2009
Last Updated
November 25, 2019
Results First Posted
August 7, 2014
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will share
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf