A Pharmacokinetic Study of Tedizolid Phosphate in Pediatric Participants With Gram-Positive Infections (MK-1986-014)

NCT ID: NCT03217565

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-06
• Study Completion Date: 2023-04-06

Brief Summary

The primary objectives of this study are to describe the single-dose, and multiple dose pharmacokinetics (PK) of intravenous (IV) tedizolid phosphate, or a single dose oral suspension of tedizolid phosphate, when administered to pediatric participants, full-term neonates, and preterm neonates.

Detailed Description

Per protocol, PK analysis in Part A Group 1 will be conducted across ages in Cohorts 1 and 2 combined: Part A Group 1 Cohort 1 + Cohort 2: 28 days to <24 months.

Conditions

Gram-Positive Infections

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part A Group 1 Cohort 1: Single Dose IV Tedizolid Phosphate 28 days to <6 months

Pediatric participants 28 days to \<6 months of age will receive a single dose (SD) intravenous (IV) infusion of tedizolid phosphate according to body weight: 3 mg/kg for body weight \<10 kg or 2.5 mg/kg for body weight 10 to \<30 kg.

Group Type: EXPERIMENTAL

IV Tedizolid Phosphate

Intervention Type: DRUG

A single dose, or twice daily dose for 3 days, of tedizolid phosphate administered IV.

Part A Group 1 Cohort 2: Single Dose IV Tedizolid Phosphate 6 months to <24 months

Pediatric participants 6 months to \<24 months of age will receive an SD IV infusion of tedizolid phosphate according to body weight: 3 mg/kg for body weight \<10 kg or 2.5 mg/kg for body weight 10 to \<30 kg.

Group Type: EXPERIMENTAL

IV Tedizolid Phosphate

Intervention Type: DRUG

A single dose, or twice daily dose for 3 days, of tedizolid phosphate administered IV.

Part A Group 2 Cohort 1: Single Dose IV Tedizolid Phosphate (full term) birth to <28 days

Full term (FT) neonates from birth to \<28 days of age will receive an SD IV infusion of tedizolid phosphate according to body weight: 3 mg/kg for body weight \<10 kg or 2.5 mg/kg for body weight 10 to \<30 kg.

Group Type: EXPERIMENTAL

IV Tedizolid Phosphate

Intervention Type: DRUG

A single dose, or twice daily dose for 3 days, of tedizolid phosphate administered IV.

Part A Group 2 Cohort 2: Multiple Dose IV Tedizolid Phosphate (full term) birth to <28 days

FT neonates from birth to \<28 days of age will receive multiple dose (MD) IV infusions of tedizolid phosphate according to body weight: 3 mg/kg for body weight \<10 kg or 2.5 mg/kg for body weight 10 to \<30 kg, administered twice daily for 3 days.

Group Type: EXPERIMENTAL

IV Tedizolid Phosphate

Intervention Type: DRUG

A single dose, or twice daily dose for 3 days, of tedizolid phosphate administered IV.

Part A Group 3 Cohort 1: Single Dose IV Tedizolid Phosphate (preterm) birth to <28 days

Preterm (PT) neonates from birth to \<28 days of age will receive an SD IV infusion of tedizolid phosphate according to body weight: 3 mg/kg for body weight \<10 kg or 2.5 mg/kg for body weight 10 to \<30 kg.

Group Type: EXPERIMENTAL

IV Tedizolid Phosphate

Intervention Type: DRUG

A single dose, or twice daily dose for 3 days, of tedizolid phosphate administered IV.

Part A Group 3 Cohort 2: Multiple Dose IV Tedizolid Phosphate IV (preterm) birth to <28 days

PT neonates from birth to \<28 days of age will receive MD IV infusions of tedizolid phosphate according to body weight: 3 mg/kg for body weight \<10 kg or 2.5 mg/kg for body weight 10 to \<30 kg, administered twice daily for 3 days.

Group Type: EXPERIMENTAL

IV Tedizolid Phosphate

Intervention Type: DRUG

A single dose, or twice daily dose for 3 days, of tedizolid phosphate administered IV.

Part B Group 4: Single Dose Oral Tedizolid Phosphate 28 days to <24 months

Pediatric participants 28 days to \<24 months of age will receive an SD oral suspension of tedizolid phosphate according to body weight: 3 mg/kg for body weight \<10 kg or 2.5 mg/kg for body weight 10 to \<30 kg.

Group Type: EXPERIMENTAL

Oral Suspension Tedizolid Phosphate

Intervention Type: DRUG

A single dose of tedizolid phosphate administered as an oral suspension.

Part B Group 5: Single Dose Oral Tedizolid Phosphate (full term) birth to <28 days

FT neonates from birth to \<28 days of age will receive an SD oral suspension of tedizolid phosphate according to body weight: 3 mg/kg for body weight \<10 kg or 2.5 mg/kg for body weight 10 to \<30 kg.

Group Type: EXPERIMENTAL

Oral Suspension Tedizolid Phosphate

Intervention Type: DRUG

A single dose of tedizolid phosphate administered as an oral suspension.

Part B Group 6: Single Dose Oral Tedizolid Phosphate (preterm) birth to <28 days

PT neonates from birth to \<28 days of age will receive an SD oral suspension of tedizolid phosphate according to body weight: 3 mg/kg for body weight \<10 kg or 2.5 mg/kg for body weight 10 to \<30 kg.

Group Type: EXPERIMENTAL

Oral Suspension Tedizolid Phosphate

Intervention Type: DRUG

A single dose of tedizolid phosphate administered as an oral suspension.

Interventions

IV Tedizolid Phosphate

A single dose, or twice daily dose for 3 days, of tedizolid phosphate administered IV.

Intervention Type: DRUG

Oral Suspension Tedizolid Phosphate

A single dose of tedizolid phosphate administered as an oral suspension.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Is receiving prophylaxis for or has a confirmed or suspected infection with gram-positive bacteria and receiving concurrent antibiotic treatment with gram -positive antibacterial activity.
• Is at least 1 kg in weight.
• Is in stable condition as determined from medical history, physical examination, electrocardiogram (ECG), vital signs, and clinical laboratory evaluations.
• Has no clinically significant ECG abnormalities.
• Has sufficient vascular access to receive trial drug, and allow for required blood draws.
• Is able to receive medication by mouth, for those dosed with oral suspension; dose administration via feeding tube is acceptable.

Exclusion Criteria

• Has a history of seizures, other than febrile seizures, clinically significant cardiac arrhythmia or condition, moderate or severe renal impairment, or any physical condition that could interfere with the interpretation of the study results, as determined by the Investigator.
• Has used rifampin within 14 days prior to dosing.
• Has used or will be using proton pump inhibitors, H2 blockers, or antacids (for participants in Part B, i.e, oral suspension dose) at any time from 24 hours prior to dosing through 24 hours after dosing..
• Has a recent (3-month) history or current infection with viral hepatitis or other significant hepatic disease.
• Has a history of drug allergy or hypersensitivity to oxazolidinones.
• Has had significant blood loss.
• Need for oral administration of topotecan, rosuvastatin, irinotecan, or methotrexate during administration of oral study drug.
• Used monoamine oxidase inhibitors (MAOIs) or serotonergic agents including tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRIs), and serotonin 5-hydroxytryptamine receptor agonists (triptans), meperidine, or buspirone within 14 days prior to study, or planned use while on study.
• Has received another investigational product within the 30 days prior to enrollment.

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

Arkansas Children's Hospital ( Site 1012)

Little Rock, Arkansas, United States

Children's Hospital of Orange County ( Site 1001)

Orange, California, United States

Sharp Memorial Hospital ( Site 1021)

San Diego, California, United States

Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 1022)

Chicago, Illinois, United States

Our Lady of the Lake Regional Medical Center. ( Site 1004)

Baton Rouge, Louisiana, United States

Saint Louis Children's Hospital ( Site 1020)

St Louis, Missouri, United States

Primary Children's Hospital ( Site 1000)

Salt Lake City, Utah, United States

Medical Center - 1- Sevlievo EOOD ( Site 2207)

Sevlievo, Gabrovo, Bulgaria

MHAT Sv. Ivan Rilski EOOD ( Site 2201)

Kozloduy, Vratsa, Bulgaria

UMHAT Deva Maria ( Site 2208)

Burgas, , Bulgaria

MHAT Dr. Tota Venkova-Pediatrics ( Site 2218)

Gabrovo, , Bulgaria

MHAT "Dr. Stamen Iliev" Montana ( Site 2215)

Montana, , Bulgaria

MHAT City Clinic Sv. Georgi EOOD ( Site 2202)

Montana, , Bulgaria

UMHAT Dr. Georgi Stranski EAD ( Site 2211)

Pleven, , Bulgaria

MHAT Rousse-Neonatology ( Site 2213)

Rousse, , Bulgaria

Multiprofile Hospital for Active Treatment - Ruse ( Site 2204)

Rousse, , Bulgaria

UMHAT Kanev AD ( Site 2209)

Rousse, , Bulgaria

MHAT Dr. Ival Seliminski ( Site 2212)

Sliven, , Bulgaria

Hospital San Vicente Fundacion ( Site 1103)

Medellín, Antioquia, Colombia

Clinica de la Costa S.A.S. ( Site 1106)

Barranquilla, Atlántico, Colombia

Fundacion Hospital Infantil Universitario de San Jose ( Site 1107)

Bogotá, Bogota D.C., Colombia

Fundacion Valle del Lili ( Site 1102)

Cali, Valle del Cauca Department, Colombia

Akershus Universitetssykehus HF ( Site 1604)

Loerenskog, Akershus, Norway

Haukeland Universitetssjukehus ( Site 1602)

Bergen, Hordaland, Norway

Stavanger Universitetssykehus, Helse Stavanger ( Site 1601)

Stavanger, Rogaland, Norway

St. Olavs Hospital. ( Site 1600)

Trondheim, Sor-Trondelag, Norway

University Hospital Southampton NHS Foundation Trust ( Site 1700)

Southampton, Hampshire, United Kingdom

Alder Hey Childrens NHS Foundation Trust Hospital ( Site 1703)

Liverpool, Lancashire, United Kingdom

Royal Victoria Infirmary ( Site 1702)

Newcastle, Newcastle Upon Tyne, United Kingdom

Oxford University Hospitals NHS Foundation Trust ( Site 1704)

Oxford, Oxfordshire, United Kingdom

Countries

United States; Bulgaria; Colombia; Norway; United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://www.merckclinicaltrials.com

Merck Clinical Trials Information

Other Identifiers

MK-1986-014

Identifier Type: OTHER

Identifier Source: secondary_id

2017-000953-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1986-014

Identifier Type: -

Identifier Source: org_study_id