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NOT YET RECRUITING
NCT07070102

Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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

OTHER

blood samples

2 blood samples of 1 mL

Locations (1)

Robert Debre Hospital

Paris, Ap-hp / DRCI, France