A Study of Oral and Intravenous (IV) Tedizolid Phosphate in Hospitalized Participants, Ages 2 to <12 Years, With Confirmed or Suspected Bacterial Infection (MK-1986-013)
Condition: Gram-Positive Bacterial Infections
MeSH terms: Infections; Bacterial Infections; Gram-Positive Bacterial Infections
Intervention: Tedizolid Phosphate (IV); Tedizolid Phosphate (oral suspension)
Intervention description: 200 mg/vial powder for injection; Powder for oral suspension 20 mg/mL following reconstitution
Intervention MeSH terms: Tedizolid phosphate; Tedizolid; Oxazolidinones
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 2 Years
Maximum age: 11 Years
Healthy volunteers: No

Summary:

      This is a study to assess the pharmacokinetics (PK) of tedizolid phosphate and its active
      metabolite, tedizolid, and the safety of tedizolid phosphate following administration of a
      single IV (Part A) or oral suspension (Part B) administration to hospitalized participants
      ages 6 to <12 years (Groups 1 and 3, respectively), and 2 to <6 years (Groups 2 and 4,
      respectively).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Receiving prophylaxis for or with a confirmed or suspected infection with
             Gram-positive bacteria and receiving concurrent antibiotic treatment with
             Gram-positive antibacterial activity;

          -  Weight >5th percentile and <95th percentile based on age;

          -  Stable condition as determined from medical history, physical examination, minimally
             5-lead electrocardiogram (ECG), vital signs, and clinical laboratory evaluations;

          -  Females must be premenarchal, abstinent, or practicing an effective method of birth
             control;

        Exclusion Criteria:

          -  History of seizures, other than febrile seizures, clinically significant cardiac
             arrhythmia, cystic fibrosis, moderate or severe renal impairment, or any physical
             condition that could interfere with the study results;

          -  Recent (3 month) history or current infection with viral hepatitis or other
             significant hepatic disease;

          -  History of drug allergy or hypersensitivity to oxazolidinones;

          -  Pregnant or breast feeding;

          -  Significant blood loss within 60 days prior to study start;

          -  Any acute or chronic condition that would limit the participant's ability to complete
             and/or participate in this clinical study.

          -  Treatment with investigational medicinal product within 30 days before the
             infusion/dose of study drug.

          -  Oral administration of methotrexate, topotecan, irinotecan or rosuvastatin, during
             administration of oral study drug. Administration during the follow-up period is
             allowed, as is administration during treatment with IV study drug.

          -  Use of monoamine oxidase inhibitors or serotonergic agents including tricyclic
             antidepressants, selective serotonin reuptake inhibitors, and serotonin 5
             hydroxytryptamine receptor agonists (triptans), meperidine, or buspirone within,14
             days prior to study, or planned use while on study.