Clinical Research Directory
Browse clinical research sites, groups, and studies.
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Sponsor: Assistance Publique - Hôpitaux de Paris
Summary
Temocillin, a 6-alpha-methoxypenicillin derivative of ticarcillin, is a narrow-spectrum antibiotic, primarily restricted to Enterobacterales. Therefore, its prescription for the treatment of febrile urinary tract infections requiring hospitalization in pediatrics appears interesting. However, and despite marketing authorization in pediatrics for the treatment of complicated urinary tract infections (including acute pyelonephritis), the pharmacokinetic parameters of this antibiotic have not been specifically evaluated in pediatrics, and the optimal dose is not known in this population. Through this study, we propose to determine the pharmacokinetic parameters of temocillin in children aged 0-15 years with a febrile urinary tract infection due to Gram-negative rod (GNR), without sepsis but requiring hospitalization. The results will help to establish dose recommendations for temocillin in the pediatric population, based on age and renal function.
Key Details
Gender
All
Age Range
1 Day - 15 Years
Study Type
OBSERVATIONAL
Enrollment
50
Start Date
2025-09-01
Completion Date
2027-09-01
Last Updated
2025-07-17
Healthy Volunteers
No
Conditions
Interventions
blood samples
2 blood samples of 1 mL
Locations (1)
Robert Debre Hospital
Paris, Ap-hp / DRCI, France