Overview

Temocillin Pharmacokinetics in Paediatrics

Status:
Unknown status
Trial end date:
2019-10-31
Target enrollment:
Participant gender:
Summary
Temocillin (6-methoxy-ticarcillin) is a beta-lactam antibiotic with exceptional resistance to most beta-lactamases. In this context, it is now increasingly used as carbapenem-sparing antibiotic in patients with suspected infection by Enterobactreriaceae suspected to produce extended-spectrum beta-lactamases. Little is known about dosing and elimination of temocillin in children. While available literature of temocillin use in paediatrics refers mainly to its clinical efficacy in the treatment of urinary tract infections, the drug is also used for the treatment of suspicion of cholangitis in cirrhotic paediatric patients, and as antibiotic prophylaxis following an hepatic transplant in children (both off-label indications). There is, therefore, a pressing need to explore the pharmacokinetics and pharmacodynamics of temocillin in the paediatric population, in order to provide clear guidance on an appropriate dosing regimen. The study objectives are: (1) characterisation of the pharmacokinetics (PK) of temocillin in 3 paediatric populations, (2) proposal and development of a dosing schedule that can ensure therapeutic concentrations (40% ƒT > MIC) and optimize treatment chances of success, and (3) characterization of MICs of microbiological strains (when available) to temocillin.
Phase:
Phase 4
Details
Lead Sponsor:
Université Catholique de Louvain
Treatments:
Penicillins
Temocillin