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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 : Completed
First Posted : October 28, 2014
Results First Posted : August 7, 2019
Last Update Posted : August 7, 2019
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 Drug: Antibiotic comparator Drug: Aztreonam Drug: Metronidazole 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
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
Actual Primary Completion Date : September 17, 2018
Actual Study Completion Date : September 17, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tedizolid Phosphate
Tedizolid Phosphate IV and/or oral 200 mg once per day for 6 days. Participants with gram-negative wound infection may receive aztreonam (IV) and/or metronidazole (IV or oral).
Drug: Tedizolid Phophate
Tedizolid Phophate 200 mg, IV and/or oral for 6 days
Other Names:
  • TR701-122
  • MK-1986
  • SIVEXTRO®

Drug: Aztreonam
In countries and/or sites where aztreonam is available, adjunctive aztreonam (IV) may be initiated on Day 1 or during the first 3 days of treatment if the participant is determined or suspected to have an infection with gram-negative aerobic pathogens.
Other Name: Azactam, Cayston

Drug: Metronidazole
Metronidazole (IV or oral) may be initiated on Day 1 or during the first 3 days of treatment if the participant is determined or suspected to have an infection with anaerobic pathogens.
Other Name: Flagyl, Metro

Active Comparator: Antibiotic comparator drug
IV and/or oral antibiotic comparator drug for 10 days. Participants with gram-negative wound infection may receive aztreonam (IV) and/or metronidazole (IV or oral).
Drug: Antibiotic comparator
Antibiotic comparator drug, IV and/or orally for 10 days. Antibiotic comparator included the following: Vancomycin, Linezolid, Clindamycin, Flucloxacillin, Cefazolin, Cephalexin.
Other Name: Vancomycin: Vancocin, Firvanq, Lyphocin; Linezolid: Zyvox; Clindamycin: Cleocin; Flucloxacillin: Floxapen, Flopen, Staphylex; Cefazolin: Ancef, Kefzol; Cephalexin: Keflex, Zartan, Panixine, Biocef

Drug: Aztreonam
In countries and/or sites where aztreonam is available, adjunctive aztreonam (IV) may be initiated on Day 1 or during the first 3 days of treatment if the participant is determined or suspected to have an infection with gram-negative aerobic pathogens.
Other Name: Azactam, Cayston

Drug: Metronidazole
Metronidazole (IV or oral) may be initiated on Day 1 or during the first 3 days of treatment if the participant is determined or suspected to have an infection with anaerobic pathogens.
Other Name: Flagyl, Metro




Primary Outcome Measures :
  1. Number of Participants With Adverse Events on Tedizolid Phosphate and Comparator Drugs [ Time Frame: Up to 40 days (including 30-day follow-up) ]
    An adverse event (AE) refers to a treatment-emergent adverse event (TE-AE). A TE-AE is any AE that newly appeared, increased in frequency, or worsened in severity following initiation of study drug.


Secondary Outcome Measures :
  1. Number of Participants With Investigator's Assessment Indicating Clinical Success at Test of Cure (TOC) Visit (Intent to Treat Analysis Set) [ Time Frame: TOC Visit: 18-25 days after first drug infusion ]
    Investigator's assessment of clinical success is defined as (1) resolution or near resolution of most disease-specific signs and symptoms, (2)absence or near resolution of regional or systemic signs of infection (lymphadenopathy, fever, >10% immature neutrophils, abnormal white blood cell count), if present at baseline, and (3) no new signs, symptoms, or complications attributable to the infection under study so no further antibiotic therapy is required for the treatment of the primary lesion.

  2. Number of Participants With Investigator's Assessment Indicating Clinical Success at TOC Visit (Clinically Evaluable-Test of Cure [CE-TOC] Analysis Set) [ Time Frame: TOC Visit: 18-25 days after first drug infusion ]
    Investigator's assessment of clinical success is defined as (1) resolution or near resolution of most disease-specific signs and symptoms, (2)absence or near resolution of regional or systemic signs of infection (lymphadenopathy, fever, >10% immature neutrophils, abnormal white blood cell count), if present at baseline, and (3) no new signs, symptoms, or complications attributable to the infection under study so no further antibiotic therapy is required for the treatment of the primary lesion.

  3. Number of Participants With Early Clinical Responses Measured by Lesion Reduction [ Time Frame: 48-72 hr after first drug infusion ]
    Early clinical response is defined as ≥20% reduction from baseline lesion area (defined as length multiplied by the width of the erythema, edema, and/or induration [EEI]) at the 48-72 hour (hr) visit.

  4. Number of Participants With Investigator's Assessment Indicating Clinical Success at End of Therapy (EOT) Visit (Intent to Treat Analysis Set) [ Time Frame: EOT Visit: up to 13 days after first drug infusion ]
    Investigator's assessment of clinical success is defined as (1) resolution or near resolution of most disease-specific signs and symptoms, (2)absence or near resolution of regional or systemic signs of infection (lymphadenopathy, fever, >10% immature neutrophils, abnormal white blood cell count), if present at baseline, and (3) no new signs, symptoms, or complications attributable to the infection under study so no further antibiotic therapy is required for the treatment of the primary lesion.

  5. Number of Participants With Investigator's Assessment Indicating Clinical Success at EOT Visit (Clinically Evaluable-End of Therapy [CE-EOT] Analysis Set) [ Time Frame: EOT Visit: up to 13 days after first drug infusion ]
    Investigator's assessment of clinical success is defined as (1) resolution or near resolution of most disease-specific signs and symptoms, (2) absence or near resolution of regional or systemic signs of infection (lymphadenopathy, fever, >10% immature neutrophils, abnormal white blood cell count), if present at baseline, and (3) no new signs, symptoms, or complications attributable to the infection under study so no further antibiotic therapy is required for the treatment of the primary lesion.


Other Outcome Measures:
  1. Change From Baseline in Lesion Size [ Time Frame: Baseline and TOC visit (18 to 25 days after infusion) ]
    Lesion size is the area in cm^2 of erythema, edema or induration. A negative number corresponds to a decrease in lesion size.

  2. Peak Plasma Concentration (Cmax) of Tedizolid [ Time Frame: Day 1 at 5-80 minutes (min) and 4-12 hrs post-infusion or 2 samples collected between 4-12 hrs after oral dose, at least 60 min apart; at 48-72 hrs: within 60 min prior to administration and 4-12 hrs after administration; and anytime between Day 7 and 9 ]
    The Cmax of tedizolid in plasma after the last dose was estimated based on population pharmacokinetic analysis of observed pharmacokinetic data. Blood samples were collected for pharmacokinetic analysis at specific time points.

  3. Area Under the Plasma Concentration Versus Time Curve Time 0 to 24 Hours (AUC0-24h) of Tedizolid [ Time Frame: Day 1 at 5-80 min and 4-12 hrs post-infusion or 2 samples collected between 4-12 hrs after oral dose, at least 60 min apart; at 48-72 hrs: within 60 min prior to administration and 4-12 hrs after administration; and anytime between Day 7 and 9 ]
    AUC0-24h is a measure of the total tedizolid exposure in the plasma from the dose to 24 hours after last dose. AUC0-24h was estimated based on population pharmacokinetic analysis of observed pharmacokinetic data. Blood samples were collected for pharmacokinetic analysis at specific time points.



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Ages Eligible for Study:   12 Years to 17 Years   (Child)
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


Sponsors and Collaborators
Cubist Pharmaceuticals LLC
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.
  Study Documents (Full-Text)

Documents provided by Cubist Pharmaceuticals LLC:

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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 )
MK-1986-012 ( Other Identifier: Merck )
First Posted: October 28, 2014    Key Record Dates
Results First Posted: August 7, 2019
Last Update Posted: August 7, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Communicable Diseases
Infection
Skin Diseases, Infectious
Skin Diseases, Bacterial
Skin Diseases
Bacterial Infections
Anti-Bacterial Agents
Metronidazole
Vancomycin
Clindamycin
Linezolid
Cefazolin
Aztreonam
Cephalexin
Tedizolid
Floxacillin
Tedizolid phosphate
Antibiotics, Antitubercular
Oxazolidinones
Anti-Infective Agents
Antitubercular Agents
Antiprotozoal Agents
Antiparasitic Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action