A Single-dose Pharmacokinetics Study of MK-7655A in Pediatric Subjects
Research type
Research Study
Full title
A Phase 1b, Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of MK-7655A in Pediatric Subjects From Birth to Less Than 18 Years of Age With Confirmed or Suspected Gram-negative Infections
IRAS ID
225047
Contact name
Saul Faust
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2016-004328-43
Duration of Study in the UK
2 years, 10 months, 20 days
Research summary
β-lactam antibiotics are among the most frequently used antimicrobial agents in clinical practice. Bacterial infections resistant to these antibiotics are becoming increasingly common in adults and children. As bacteria become resistant to antibiotics, infections previously treatable become more difficult to treat. One way bacteria develop resistance is by producing an enzyme, β-lactamase, which can destroy the antibiotic.
This study combines a well-known antibiotic (imipenem/cilastatin), which has been used in adults and children for 30 years, with a new molecule relebactam (MK-7655) which is a β-lactamase inhibitor that protects the antibiotic from the enzymes. This combination has been tested in animals and in adults and shown to work safely. This is the first study of this combination given to children and aims to test if it behaves the same way in children as in adults.
This study will primarily test the way that the body absorbs, distributes and gets rid of a single fixed-dose combination of imipenem/cilastatin/relebactam (MK-7655A) when given to children.
Hospitalised children with serious infections who are already receiving antibiotic treatment will be recruited and given a single dose of MK-7655A in the vein in addition to, not instead of, ongoing 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-7655A and followed up the next day. The last contact will be two weeks later in person or by telephone.
Approximately 44 children in five different age groups, ranging from newborns to 17 years of age, will be recruited. The study will only be done in children under 2 years old once the safety of MK-7655A has been established in the older children and the dose corrected if necessary.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
17/NE/0238
Date of REC Opinion
5 Oct 2017
REC opinion
Further Information Favourable Opinion