complicated skin and soft tissue infection (cSSTI) MedDRA version: 19.1 Level: HLT Classification code 10040786 Term: Skin structures and soft tissue infections System Organ Class: 100000004862
Conditions
Interventions
Product Name: Tedizolid Phosphate
Product Code: TR701 FA
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: Tedi
Sponsors
Cubist Pharmaceuticals LLC, an indirect wholly-owned subsidary of Merck Sharp & Dohme Corp.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Males or females 12 years to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Uncomplicated minor skin and skin structure infections such as pustules, folliculitis, furuncles, minor abscesses (small volume of suppuration not surrounded by cellulitis/erysipelas), impetiginous lesions, superficial or limited cellulitis/erysipelas, and minor wound associated foreign body reactions (e.g., "stitch abscesses") •Known bacteremia, severe sepsis or septic shock •Recent history of opportunistic infections where the underlying cause of these infections is still active (eg, leukemia, transplant, acquired immunodeficiency syndrome) •Hypersensitivity to tedizolid phosphate or any component in the formulation •Hypersensitivity to all of the comparator drugs; hypersensitivity to a comparator drug does not preclude participation if an alternative comparator can be used •For subjects with wound infections: history of hypersensitivity to ceftazidime, aztreonam, or any component of the aztreonam formulation, if aztreonam adjunctive therapy is required; history of hypersensitivity to metronidazole or any component of the formulation, if metronidazole adjunctive therapy is required
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Compare the safety of intravenous (IV) and/or oral 6-day 200 mg tedizolid phosphate with 10-day Comparator (IV and/ or oral) in subjects 12 to <18 years with complicated skin and soft tissue infection (cSSTI);Primary end point(s): Number of Subjects With Adverse Events on Tedizolid Phosphate and Comparator Drugs;Timepoint(s) of evaluation of this end point: 10 days; Secondary Objective: • Compare the Blinded Investigator's assessment of clinical success in the tedizolid phospahte and Comparator groups at the Test of Cure Visit (18 to 25 days after the first infusion) in the Intent to Treat (ITT) and Clinically Evaluable at TOC (CE TOC) Analysis Sets • Compare the programmatic early clinical response in the tedizolid phosphate and Comparator groups at the 48-72 Hour Visit in the ITT Analysis Set • Compare the Blinded Investigator's assessment of clinical success in the tedizolid phosphate ITT and CE-EOT Analysis Sets | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: a. 25 days b. 18-25 days c. 48-72 hours d. 11 days ; Secondary end point(s): a. Number of Subjects with Lesion Reduction Success b. Number of Subjects with Blinded Investigator's Assessment Indicating Clinical Success c. Number of Subjects with Early Clinical Responses Measured by Lesion Reduction d. Number of Subjects with Blinded Investigator's Assessment Indicating Early Clinical Success | — |
Countries
Argentina, Bulgaria, Chile, Czech Republic, Georgia, Germany, Latvia, Lithuania, Panama, Poland, Romania, Slovenia, South Africa, Spain, Ukraine, United States
Contacts
Public ContactPamela Sears
Cubist Pharmaceuticals LLC, an indirect wholly-owned subsidiary of Merck Sharp & Dohme Corp
Outcome results
None listed