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)

Conditions: Gram-Positive Bacterial Infections

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).

part a (iv): * group 1 (cohort 1 and cohort 2) (6 to \<12 years) * group 2 (cohort 1 and cohort 2) (2 to \<6 years) part b (oral suspension): * group 3 (6 to \<12 years) * group 4 (2 to \<6 years) in cohort 1 of group 1 (iv) participants received a single administration of tedizolid phosphate at 5 mg/kg of total body weight. after all participants in cohort 1 of group 1 received study drug, a preliminary analysis of the safety and pk data was performed and results were used to select 4 mg/kg as the appropriate dose for cohort 2 of group 1 and group 3, and to select 6 mg/kg as the starting dose for the younger participants, cohort 1 of group 2. after all participants in cohort 1 of group 2 receive study drug, another preliminary analysis of the safety and pk data will be performed and results will be used to confirm 6 mg/kg as the appropriate dose for cohort 2 of group 2. similarly, the group 4 dose will be confirmed after data review of group 3 results.

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.