Status:
UNKNOWN
Temocillin Pharmacokinetics in Paediatrics
Lead Sponsor:
Université Catholique de Louvain
Conditions:
Infection
Liver Dysfunction
Eligibility:
All Genders
6-3 years
Phase:
PHASE4
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 pat...
Detailed Description
1\. Introduction Temocillin is a beta-lactam antibiotic active against Gram-negative bacteria. Its spectrum covers family members of the Enterobacteriaceae (including many of those producing beta-lact...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
- Patients having participated in another study \< 30 days before inclusion in the present study
Key Trial Info
Start Date :
February 17 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT02260102
Start Date
February 17 2016
End Date
December 31 2022
Last Update
May 31 2022
Active Locations (1)
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1
Cliniques universitaires St-Luc
Brussels, Belgium, B1200