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Study of Tedizolid Phosphate in Adolescents With Complicated Skin and Soft Tissue Infection (cSSTI) (MK-1986-012)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Cubist Pharmaceuticals LLC
Sponsor:
Information provided by (Responsible Party):
Cubist Pharmaceuticals LLC
ClinicalTrials.gov Identifier:
NCT02276482
First received: October 9, 2014
Last updated: September 16, 2016
Last verified: September 2016
  Purpose
The purpose of the study is to compare the safety of intravenous (IV) and/or oral 6-day 200 mg tedizolid phosphate with 10-day comparator in participants 12 to <18 years with cSSTI.

Condition Intervention Phase
Skin Diseases, Infectious
Skin Diseases, Bacterial
Drug: Tedizolid Phophate 200 mg, IV and/or oral for 6 days
Drug: Antibiotic comparator
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Phase 3 Study of IV to Oral 6-Day Tedizolid Phosphate Compared With 10-day Comparator in Subjects 12 to < 18 Years With cSSTI.

Resource links provided by NLM:


Further study details as provided by Cubist Pharmaceuticals LLC:

Primary Outcome Measures:
  • Number of Participants With Adverse Events on Tedizolid Phosphate and Comparator Drugs [ Time Frame: Up to 39 days ] [ Designated as safety issue: Yes ]
    The primary objective is to compare the safety of IV and/or oral 6-day 200 mg tedizolid phosphate with 10-day Comparator standard of care in participants 12 to <18 years with cSSTI. Safety will be assessed through summaries of Treatment Emergent Adverse Events by treatment groups (tedizolid phosphate and other comparator drugs).


Secondary Outcome Measures:
  • Number of Participants with Lesion Reduction Success [ Time Frame: 25 days ] [ Designated as safety issue: No ]
    To compare the programmatic early clinical response % in the tedizolid phosphate and comparator groups defined as a >= 20% reduction from baseline lesion area in cm2 of erythema, edema or induration.

  • Number of Participants with Investigator's Assessment Indicating Clinical Success [ Time Frame: Treatment to Cure Visit: 18-25 days after first drug infusion ] [ Designated as safety issue: No ]
    To compare the Investigator's assessment of clinical success in the tedizolid phosphate and Comparator groups at the Test of Cure (TOC; 18 to 25 days after the first infusion) Visit in the Intent to Treat (ITT) and Clinically Evaluable at TOC (CE-TOC) Analysis Sets.

  • Number of Participants with Early Clinical Responses Measured by Lesion Reduction [ Time Frame: 48-72 hours after first drug infusion ] [ Designated as safety issue: No ]
    To compare the programmatic early clinical response in the tedizolid phosphate and Comparator groups at the 48-72 Hour Visit in the ITT Analysis Set

  • Number of Participants with Investigator's Assessment Indicating Early Clinical Success [ Time Frame: End of Therapy Visit: up to 13 days after first drug infusion ] [ Designated as safety issue: No ]
    To compare the Investigator's assessment of clinical success in the tedizolid phosphate and Comparator groups at the End of Therapy (EOT) Visit (Day 11+2) in the ITT and CE-EOT Analysis Sets

  • Peak Plasma Concentration (Cmax) of Tedizolid Phosphate [ Time Frame: Day 1, 48-72 hours, Day 7 ] [ Designated as safety issue: No ]
    Evaluate peak concentration of tedizolid phosphate after drug administration using validated assay.

  • Area Under the Plasma Concentration Versus Time Curve (AUC) of Tedizolid Phosphate [ Time Frame: Day 1, 48-72 hours, Day 7 ] [ Designated as safety issue: No ]
    Evaluate systemic plasma concentration of tedizolid phosphate after drug administration using a validated assay.


Estimated Enrollment: 162
Study Start Date: March 2015
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tedizolid Phosphate
IV and/or oral 200 mg once per day for 6 days
Drug: Tedizolid Phophate 200 mg, IV and/or oral for 6 days
Other Name: TR701-122
Active Comparator: Antibiotic comparator drug
IV and/or oral antibiotic comparator drug for 10 days
Drug: Antibiotic comparator
Other Name: Vancomycin, Linezolid, Clindamycin, Flucloxacillin, Cefazolin, Cephalexin

Detailed Description:
A randomized, single-blind, multicenter, Phase 3 study of IV and/or oral tedizolid phosphate 200 mg once per day for 6 days compared with IV and/or oral Comparator for 10 days for the treatment of cSSTI, also known as acute bacterial skin and skin structure infections, in participants 12 to <18 years. cSSTI includes major cutaneous abscess, cellulitis/erysipelas, and wound infection.
  Eligibility

Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females 12 years to <18 years
  • Adequate venous access for IV administration of study drug for at least 24 hours (for participants receiving IV medication) and collection of protocol-specified blood samples
  • Local symptoms must have started within 7 days before Study Day -1
  • cSSTI meeting at least 1 of the clinical syndrome definitions.
  • Suspected or documented Gram-positive infection from baseline Gram stain or culture.
  • Parent/legally authorized representative (LAR) able to give informed consent and willing and able to comply with all required study procedures. Assent is also required of children who in the Investigator's judgment are capable of understanding the nature of the study

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 (eg, 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 participants 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02276482

Contacts
Contact: Toll Free Number 1-888-577-8839

  Show 27 Study Locations
Sponsors and Collaborators
Cubist Pharmaceuticals LLC
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Cubist Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT02276482     History of Changes
Other Study ID Numbers: 1986-012  TR701-122 
Study First Received: October 9, 2014
Last Updated: September 16, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Skin Diseases
Soft Tissue Infections
Communicable Diseases
Infection
Skin Diseases, Infectious
Skin Diseases, Bacterial
Bacterial Infections
Anti-Bacterial Agents
Clindamycin
Torezolid phosphate
Torezolid
Antibiotics, Antitubercular
Oxazolidinones
Anti-Infective Agents
Antitubercular Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 26, 2016