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

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ClinicalTrials.gov Identifier: NCT02276482
Recruitment Status : Recruiting
First Posted : October 28, 2014
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Cubist Pharmaceuticals LLC

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

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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.
Actual Study Start Date : March 25, 2015
Estimated Primary Completion Date : November 7, 2018
Estimated Study Completion Date : November 7, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Number of Participants With Adverse Events on Tedizolid Phosphate and Comparator Drugs [ Time Frame: Up to 39 days ]
    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 :
  1. Number of Participants with Lesion Reduction Success [ Time Frame: 25 days ]
    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.

  2. Number of Participants with Investigator's Assessment Indicating Clinical Success [ Time Frame: Treatment to Cure Visit: 18-25 days after first drug infusion ]
    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.

  3. Number of Participants with Early Clinical Responses Measured by Lesion Reduction [ Time Frame: 48-72 hours after first drug infusion ]
    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

  4. 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 ]
    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

  5. Peak Plasma Concentration (Cmax) of Tedizolid Phosphate [ Time Frame: Day 1, 48-72 hours, Day 7 ]
    Evaluate peak concentration of tedizolid phosphate after drug administration using validated assay.

  6. Area Under the Plasma Concentration Versus Time Curve (AUC) of Tedizolid Phosphate [ Time Frame: Day 1, 48-72 hours, Day 7 ]
    Evaluate systemic plasma concentration of tedizolid phosphate after drug administration using a validated assay.



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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
  • Needs oral administration of methotrexate, topotecan, irinotecan or rosuvastatin, during administration of oral study drug.
  • Uses monoamine oxidase inhibitors, tricyclic antidepressants, buspirone, selective serotonin reuptake inhibitors and serotonin 5 hydroxytryptamine receptor agonists (triptans) within 14 days prior to study drug administration

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02276482


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

Locations
United States, Arkansas
Call for Information (Investigational Site 0121) Recruiting
Little Rock, Arkansas, United States, 72212
United States, California
Call for Information (Investigational Site 0119) Recruiting
Anaheim, California, United States, 92804
Call for Information (Investigational Site 0117) Recruiting
Fountain Valley, California, United States, 92708
Call for Information (Investigational Site 0101) Recruiting
San Diego, California, United States, 92123
United States, Michigan
Call for Information (Investigational Site 0116) Recruiting
Royal Oak, Michigan, United States, 48073
United States, Missouri
Call for Information (Investigational Site 0115) Recruiting
Kansas City, Missouri, United States, 64108
United States, Montana
Call for Information (Investigational Site 0120) Recruiting
Butte, Montana, United States, 59701
United States, Texas
Call for Information (Investigational Site 0100) Recruiting
Austin, Texas, United States, 78723
Call for Information (Investigational Site 0106) Recruiting
Fort Worth, Texas, United States, 76104
Call for Information (Investigational Site 0110) Recruiting
Houston, Texas, United States, 77030
Call for Information (Investigational Site 0118) Recruiting
Pharr, Texas, United States, 78577
Call for Information (Investigational Site 0112) Recruiting
San Antonio, Texas, United States, 78207
Bulgaria
Merck Sharp & Dohme Bulgaria EOOD Recruiting
Sofia, Bulgaria
Contact: Eran Gefen    38 (044) 393 74 80      
Georgia
Merck Sharp & Dohme IDEA, Inc. Recruiting
Tbilisi, Georgia
Contact: Eran Gefen    38 (044) 393 74 80      
Latvia
Merck Sharp & Dohme Latvija SIA Recruiting
Riga, Latvia
Contact: Katrin Moeschlin    +46 (0) 8ý578ý135 00      
Lithuania
UAB "Merck Sharp & Dohme" Recruiting
Vilnius, Lithuania
Contact: Katrin Moeschlin    +46 (0) 8ý578ý135 00      
Poland
MSD Polska Sp. Z o.o. Recruiting
Warsaw, Poland
Contact: Thomas Johansson    48 22ý478 43 24      
South Africa
MSD (Pty) LTD South Africa Recruiting
Midrand, South Africa
Contact: Khanyi Mzolo    27 11 655 3140      
Spain
Merck Sharp and Dohme de Espana S.A. Recruiting
Madrid, Spain
Contact: Joaquin Mateos Chacon    (0034) 913210600      
Ukraine
MSD Ukraine LLC Recruiting
Kiev, Ukraine
Contact: Eran Gefen    38 (044) 393 74 80      
Sponsors and Collaborators
Cubist Pharmaceuticals LLC
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.

Responsible Party: Cubist Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT02276482     History of Changes
Other Study ID Numbers: 1986-012
TR701-122 ( Other Identifier: Cubist Pharmaceuticals LLC Protocol Number )
2014-004023-40 ( EudraCT Number )
First Posted: October 28, 2014    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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