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Clinical Trials in France / NCT07070102
Starting soon Observational

Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children

NCT07070102 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique - Hôpitaux de Paris
Phase
Observational
Started
2025-09-01
Last updated
2025-07-17

Condition(s) studied

Pyelonephritis

Investigational drug(s) / intervention(s)

blood samples

blood samples: 2 blood samples of 1 mL

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.

Eligibility

Sex
ALL
Min age
1 Day
Max age
15 Years
Healthy volunteers
No
Inclusion Criteria: * Patient aged 0 to 15 years * Presenting with a febrile urinary tract infection due to GNR (a febrile urinary tract infection is defined as a urine culture showing significant leukocyturia (≥104) and direct examination showing GNR, in a patient with fever) * Requiring hospitalization in the general pediatrics, emergency (short-stay hospitalization unit), nephrology, or intensive care units of the Robert-Debré University Hospital for a presumed period of at least 48 hours. * Non-opposition of the legal representatives obtained by one of the investigator Exclusion Criteria: * Presence of sepsis (Phoenix score ≥ 2) * Gram-positive cocci (GPC) urinary tract infection (Urinalysis before antibiotic therapy revealed significant leukocyturia (≥104) and direct examination revealed GPC) * Known allergy to beta-lactam antibiotics * Severe renal impairment (glomerular filtration rate \<30 mL/min\*1.73 m2)

Primary outcome measure(s)

  • Achievement of the theoretical PK/PD target of 40% of the time spent above the MIC of the bacteria in question (fT>MIC=40%) for a temocillin dose of 50mg/kg/day in 2 IV injections of 30 min spaced 12h apart, — 24 months
    Achievement of the theoretical PK/PD target of 40% of the time spent above the MIC of the bacteria in question (fT\>MIC=40%) for a temocillin dose of 50mg/kg/day in 2 IV injections of 30 min spaced 12h apart, on the population modellisation of the unbound plasma concentration of temocillin over 24h. Samples taken 1 hour after the start of a temocillin infusion then between 6 and 8 hours after the start of the infusion or sample taken 2 hours after the start of a temocillin infusion then between 10 and 12 hours after the start of the infusion

Trial sites (1)

FacilityCityRegionStatus
Robert Debre Hospital Paris Ap-hp / DRCI

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07070102 on ClinicalTrials.gov ↗ ← All trials in France