A Single-dose Study of Tedizolid Phosphate in Pediatric Subjects < 2 Y
Research type
Research Study
Full title
A Phase 1, Single-Dose Safety and Pharmacokinetic Study of Oral and IV Tedizolid Phosphate (MK-1986) in Inpatients Under 2 Years Old
IRAS ID
232051
Contact name
Saul Faust
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2017-000953-38
Duration of Study in the UK
2 years, 6 months, 1 days
Research summary
Tedizolid phosphate (marketed as Sivextro and also known as TR-701 FA or 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 this antibiotic in children under two years of age.
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 and urine tests before and 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 two weeks later in person or by telephone.
Approximately 42 children in three different age groups, ranging from preterm newborns to 2 years of age, will be recruited.
The study is funded by Merck Sharp & Dohme Limited and will take place at four UK study centres.
Summary of study results:
The NIH results will be posted on clinicaltrials.gov in around the mid-March 2024 timeframe. In the meantime the trial results have been submitted to EudraCT on 06-Oct-2023 and the results are available via this link:
https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agba4yu73OCS9U-2BkKS40W1kfatiYvtk1-2B2gi1K6vKImual9G6VG4-2FeFhNKGHEnJKTVSnThQzpaM2TeQXcJerrV3P5jBVPJzj7ApcqtzqFUYg9zK_CJ_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YL5bGuRL5RDFemQT8T-2B8hZD91JppVrmIvMzjF81lFu1TIQ90bcFeJc2DNEPaYvphPSozbXeIUC-2Fdu4SfYHZ04xoedwP20UucjP4k6rWsJ46vTfkyr8OYt4ZILQFS7IJHg6QajTRMelaE-2BqlAl7R04IqYnP7lxm67M7VbRFSCCQUUg-3D-3D&data=05%7C01%7Cessex.rec%40hra.nhs.uk%7Cbb898c472e5c46bfe75c08dbe9dc77c7%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638360905328937567%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=rrthIxET9o68F0jxDh00BkRryB59u8J39x0QmF01Z50%3D&reserved=0
REC name
East of England - Essex Research Ethics Committee
REC reference
18/EE/0347
Date of REC Opinion
19 Dec 2018
REC opinion
Further Information Favourable Opinion