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

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Status and phase: Completed; Phase 3

Conditions: Skin Diseases, Infectious; Skin Diseases, Bacterial

Treatments: Drug: Aztreonam; Drug: Tedizolid Phophate; Drug: Antibiotic comparator; Drug: Metronidazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT02276482

1986-012

2014-004023-40 (EudraCT Number)

TR701-122 (Other Identifier)

MK-1986-012 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Tedizolid Phosphate

Experimental group

Description:

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).

Treatment:

Drug: Metronidazole

Drug: Tedizolid Phophate

Drug: Aztreonam

Antibiotic comparator drug

Active Comparator group

Description:

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).

Treatment:

Drug: Metronidazole

Drug: Antibiotic comparator

Drug: Aztreonam