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

• Status: Completed
• Trial end date: 2018-09-17
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cubist Pharmaceuticals LLC
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Aztreonam; Cefazolin; Cephalexin; Clindamycin; Linezolid; Metronidazole; Oxazolidinones; Tedizolid; Torezolid; Torezolid phosphate; Vancomycin

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