Temocillin Pharmacokinetics in Paediatrics
TEMOPEDI
1 other identifier
interventional
45
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Feb 2016
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2014
CompletedFirst Posted
Study publicly available on registry
October 9, 2014
CompletedStudy Start
First participant enrolled
February 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedMay 31, 2022
May 1, 2022
6.9 years
October 1, 2014
May 24, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Serum levels of temocillin
Characterisation of the pharmacokinetics (PK) of temocillin (total and free concentrations) in the 3 paediatric populations included
18 months
Study Arms (3)
urinary tract infections
ACTIVE COMPARATORChildren requiring antibiotic treatment for urinary tract infections. Intervention: blood sampling for assay of temocillin
cholangitis
ACTIVE COMPARATORCirrhotic children requiring antibiotic treatment due to suspicion of cholangitis. Intervention: blood sampling for assay of temocillin
hepatic transplant
ACTIVE COMPARATORChildren requiring antibiotic prophylaxis following a hepatic transplant. Intervention: blood sampling for assay of temocillin
Interventions
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 \[no change due to enrollment in the study\]).
Eligibility Criteria
You may qualify if:
- patient requiring temocillin
- for the treatment of urinary tract infections, or
- for the treatment of suspicion of cholangitis associated with cirrhosis, or
- as antibiotic prophylaxis following an hepatic transplant.
- patient requiring hospitalization (not for social or other non-medical reasons) for at least up to 5 days
- Parents or legal representatives able to give written informed consent in accordance with GCP and local regulatory requirements, prior to any study procedure
You may not qualify if:
- Ig-E mediated allergy to penicillins
- Previous treatment with temocillin for the current cholangitis episode
- Diagnosis of Alagille syndrome
- Estimated life-expectance of \< 5 days due to major co-morbid conditions
- Other serious illnesses, e.g. HIV, serious infections requiring other antibiotics, malignancy
- Patients with acute or chronic renal failure (eGFR \< 30ml/min)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cliniques universitaires St-Luc
Brussels, B1200, Belgium
Related Publications (3)
De Jongh R, Hens R, Basma V, Mouton JW, Tulkens PM, Carryn S. Continuous versus intermittent infusion of temocillin, a directed spectrum penicillin for intensive care patients with nosocomial pneumonia: stability, compatibility, population pharmacokinetic studies and breakpoint selection. J Antimicrob Chemother. 2008 Feb;61(2):382-8. doi: 10.1093/jac/dkm467. Epub 2007 Dec 10.
PMID: 18070831BACKGROUNDLivermore DM, Tulkens PM. Temocillin revived. J Antimicrob Chemother. 2009 Feb;63(2):243-5. doi: 10.1093/jac/dkn511. Epub 2008 Dec 18.
PMID: 19095679BACKGROUNDMiranda Bastos AC, Vandecasteele SJ, Tulkens PM, Spinewine A, Van Bambeke F. Development and validation of a high performance liquid chromatography assay for the determination of temocillin in serum of haemodialysis patients. J Pharm Biomed Anal. 2014 Mar;90:192-7. doi: 10.1016/j.jpba.2013.12.002. Epub 2013 Dec 12.
PMID: 24389461BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Françoise Van Bambeke, PharmD, PhD
Université Catholique de Louvain
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Invited Professor
Study Record Dates
First Submitted
October 1, 2014
First Posted
October 9, 2014
Study Start
February 17, 2016
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
May 31, 2022
Record last verified: 2022-05