Temocillin Pharmacokinetics in Paediatrics

• Status: Unknown status
• Trial end date: 2019-10-31
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Université Catholique de Louvain
• Treatments: Penicillins; Temocillin

Criteria

Inclusion Criteria:

• patient requiring temocillin

1. for the treatment of urinary tract infections, or

2. for the treatment of suspicion of cholangitis associated with cirrhosis, or

3. 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

Exclusion Criteria:

1. Ig-E mediated allergy to penicillins

2. Previous treatment with temocillin for the current cholangitis episode

3. Diagnosis of Alagille syndrome

4. Estimated life-expectance of < 5 days due to major co-morbid conditions

5. Other serious illnesses, e.g. HIV, serious infections requiring other antibiotics, malignancy

6. Patients with acute or chronic renal failure (eGFR < 30ml/min)

7. Patients having participated in another study < 30 days before inclusion in the present study