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Temocillin Pharmacokinetics in Paediatrics

NCT02260102 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2022-05-31

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Temocillin

Venous blood will be drawn (as per the protocol) for assay of temocillin on day 1 and day 4 of treatment. This is not part of our standard of care and is, therefore, an intervention. Patients are enrolled only if receiving temocillin as part of their normal standard of care (and the drug will be administered based on current recommendations \[no change due to enrollment in the study\]).

Sponsors & Collaborators

  • Université Catholique de Louvain

    lead OTHER

Principal Investigators

  • Françoise Van Bambeke, PharmD, PhD · Université Catholique de Louvain

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-17
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Belgium

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02260102 on ClinicalTrials.gov