Temocillin pharmacokinetics in kids with febrile urinary tract infection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study will measure pharmacokinetic parameters of temocillin in pediatric patients with febrile urinary tract infections caused by Gram-negative rods. Eligible participants are children 0 to 15 years old hospitalized for at least 48 hours and with a culture-confirmed GNR infection. Blood samples will be collected to characterize how the drug is absorbed, distributed, metabolized, and excreted in this population, aiming to support age- and renal function–based dosing. The goal is to establish dose recommendations that optimize efficacy while minimizing toxicity in pediatrics. The study is conducted at Robert Debré University Hospital under the Assistance Publique - Hôpitaux de Paris.

Why it matters

Who can join: the full rules

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)

Where it's running

• Robert Debre Hospital
  Paris, Ap-hp / DRCI, France Recruiting

Study contacts

• Principal investigator: Gabriel LIGNIERES, MD — Assistance Publique - Hôpitaux de Paris
• Study coordinator: Gabriel LIGNIERES, MD
• Email: GABRIEL.LIGNIERES@aphp.fr
• Phone: +331 40 03 53 61

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.