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Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children

NCT07070102 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2025-07-17

No results posted yet for this study

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.

Conditions

  • Pyelonephritis

Interventions

OTHER

blood samples

2 blood samples of 1 mL

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Gabriel LIGNIERES, MD · Assistance Publique - Hôpitaux de Paris

Eligibility

Min Age
1 Day
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2027-09-01
Completion
2027-09-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07070102 on ClinicalTrials.gov