A Single-Dose study of Tedizolid Phosphate in Pediatrics 2<12years
Research type
Research Study
Full title
A Phase 1, Single-Administration Pharmacokinetic and Safety Study of Oral and IV Tedizolid Phosphate in Hospitalized Subjects 2 to <12 Years Old
IRAS ID
238897
Contact name
Saul Faust
Contact email
Sponsor organisation
Cubist Pharmaceuticals, LLC
Eudract number
2015-004595-29
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Tedizolid phosphate (marketed as Sivextro and also known as TR-701 FA/MK-1986) is a novel antibiotic which has shown effectiveness in Gram-positive bacteria, particularly in the treatment of acute bacterial skin and skin structure infections. It was approved in Europe for use in adults in March 2015. Other studies have since examined the use of tedizolid phosphate in adolescents. This trial is the first to study the use of MK-1986 in children between the ages of 2 to 12 years and the results may be further used to determine safe and effective doses in younger children (neonates, infants/toddlers).
This pharmacokinetic study will examine the way that the body absorbs, distributes, processes and gets rid of a single dose of MK-1986 when given to children. It will be conducted in two parts. Participants in the first part will receive the single dose intravenously and participants in the second part will receive it orally.
The recruited study participants will be hospitalised children with confirmed or suspected Gram-positive infection who are already receiving antibiotic treatment. They will be given a single dose of MK-1986 in the vein or orally in addition to their existing therapy. Blood tests after receiving the drug will measure the level of the drug as the body processes it. Children will be screened for eligibility before being given MK-1986 and followed up the next day. The last contact will be 11 days after screening.
Approximately 32 children in two different age groups, ranging from 2 to <12 years of age, will be recruited. Children recruited in the first half of the study will receive the drug intravenously and children in the second half of the study will receive the drug orally.
The study is funded by Merck Sharp & Dohme Limited and will take place at three UK study centres.
REC name
East of England - Essex Research Ethics Committee
REC reference
18/EE/0080
Date of REC Opinion
29 May 2018
REC opinion
Further Information Favourable Opinion