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

Completed · Phase 1

Conditions studied: Gram-Positive Infections

In brief

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.

Key facts

Study ID

NCT03217565

Run by

Merck Sharp & Dohme LLC

People needed

47

Starts

2019-02-06

Expected to finish

2023-04-06

Last updated by the study team

2025-02-11

Who can join

Age: 0 and older, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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