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.
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
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)
Patient aged 0 to 15 years (inclusive) presenting with a febrile urinary tract infection with BGN requiring hospitalization in the departments of the Robert-Debré University Hospital for a duration of at least 48 hours
Other
Prospective
blood samples
Other intervention2 blood samples of 1 mL
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,
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
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