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.
Brief Title
Study of Tedizolid Phosphate in Adolescents With Complicated Skin and Soft Tissue Infection (cSSTI) (MK-1986-012)
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Skin Diseases, Infectious
Skin Diseases, Bacterial
Eligibility 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
* 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
Inclusion 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
* 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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
17 Years
Minimum Age
12 Years
NCT Id
NCT02276482
Org Class
Industry
Org Full Name
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Org Study Id
1986-012
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
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.
Primary Outcomes
Outcome Description
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.
Outcome Measure
Number of Participants With Adverse Events on Tedizolid Phosphate and Comparator Drugs
Outcome Time Frame
Up to 40 days (including 30-day follow-up)
Secondary Ids
Secondary Id
TR701-122
Secondary Id
2014-004023-40
Secondary Id
MK-1986-012
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
TOC Visit: 18-25 days after first drug infusion
Outcome Measure
Number of Participants With Investigator's Assessment Indicating Clinical Success at Test of Cure (TOC) Visit (Intent to Treat Analysis Set)
Outcome Description
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.
Outcome Time Frame
TOC Visit: 18-25 days after first drug infusion
Outcome Measure
Number of Participants With Investigator's Assessment Indicating Clinical Success at TOC Visit (Clinically Evaluable-Test of Cure [CE-TOC] Analysis Set)
Outcome Description
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.
Outcome Time Frame
48-72 hr after first drug infusion
Outcome Measure
Number of Participants With Early Clinical Responses Measured by Lesion Reduction
Outcome Description
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.
Outcome Time Frame
EOT Visit: up to 13 days after first drug infusion
Outcome Measure
Number of Participants With Investigator's Assessment Indicating Clinical Success at End of Therapy (EOT) Visit (Intent to Treat Analysis Set)
Outcome Description
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.
Outcome Time Frame
EOT Visit: up to 13 days after first drug infusion
Outcome Measure
Number of Participants With Investigator's Assessment Indicating Clinical Success at EOT Visit (Clinically Evaluable-End of Therapy [CE-EOT] Analysis Set)
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Child
Maximum Age Number (converted to Years and rounded down)
17
Minimum Age Number (converted to Years and rounded down)
12
Investigators
Investigator Type
Principal Investigator
Investigator Name
David Goldman
Investigator Email
DAGOLDMA@montefiore.org
Investigator Phone
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