RECRUITINGOBSERVATIONAL

Study of the Pharmacokinetics of Ceftriaxone

Study of the Pharmacokinetics of Ceftriaxone in Urinary Tract Infections in the Emergency Department

About This Trial

Urinary tract infections (UTIs) are the leading cause of community-acquired bacterial infections in adults. They are a common reason for admission to the Emergency Department (ED), particularly when pyelonephritis is suspected. The main bacteria responsible for UTIs are Enterobacteriaceae, with Escherichia coli being the main cause, found in more than 90% of cases. The French guidelines of the SPLIF (French-Speaking Infectious Pathology Society) recommend the probabilistic use of a 3rd generation cephalosporin or a fluoroquinolone. Ceftriaxone is often chosen over cefotaxime because it can be injected only once a day, which simplifies its administration in overcrowded emergency departments. There are currently no SPLIF recommendations regarding the dosage of ceftriaxone to be administered. The IDSA (Infectious Diseases Society of America) suggests a single dosage of 1 gram/day. Ceftriaxone is a 3rd generation cephalosporin antibiotic in the β-lactam class. Its mechanism of action is based on the inhibition of bacterial cell wall synthesis. Due to its broad spectrum against Gram-positive and Gram-negative aerobic bacteria and also some anaerobic germs, ceftriaxone is a commonly prescribed antibiotic in emergency departments (Therapeutic Guidelines Limited, Melbourne, 2014; Kumar et al., 2009) because of its broad indications: neuromeningeal infections, intra-abdominal infections and urinary tract infections (UTIs). Since most UTIs requiring hospitalization do not require intensive care, the optimal dosage of ceftriaxone in this context remains to be determined. Indeed, patients in emergency departments are on average less serious, without sepsis or septic shock, and therefore with probably different pharmacokinetic parameters.

Who May Be Eligible (Plain English)

Who May Qualify: - Adult patient over 18 years of age - Requiring hospitalization at Rouen University Hospital - Clinical diagnosis of urinary tract infection requiring ceftriaxone antibiotic therapy - Prescription of 1g IV ceftriaxone - Venipuncture for laboratory testing as part of the prescribed treatment within 24 hours of the first ceftriaxone injection - Patient has read and understood the information letter and given oral consent to participate in the study Who Should NOT Join This Trial: - Minor patient - Patient hospitalized in an intensive care unit - Patient with septic shock - Chronic dialysis or indication for emergency renal replacement therapy (ERP) - Prescription of a dosage other than 1g intravenously per 24 hours - Patient having received more than one injection of 1g ceftriaxone - Pregnant, parturient, or breastfeeding woman - Person deprived of liberty by an administrative or judicial decision - Person placed under judicial protection, guardianship, or curatorship Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Adult patient over 18 years of age * Requiring hospitalization at Rouen University Hospital * Clinical diagnosis of urinary tract infection requiring ceftriaxone antibiotic therapy * Prescription of 1g IV ceftriaxone * Venipuncture for laboratory testing as part of the prescribed treatment within 24 hours of the first ceftriaxone injection * Patient has read and understood the information letter and given oral consent to participate in the study Exclusion Criteria: * Minor patient * Patient hospitalized in an intensive care unit * Patient with septic shock * Chronic dialysis or indication for emergency renal replacement therapy (ERP) * Prescription of a dosage other than 1g intravenously per 24 hours * Patient having received more than one injection of 1g ceftriaxone * Pregnant, parturient, or breastfeeding woman * Person deprived of liberty by an administrative or judicial decision * Person placed under judicial protection, guardianship, or curatorship

Treatments Being Tested

BIOLOGICAL

free ceftriaxone concentration dosage

The proportion of patients with UTI for whom the time spent with a free ceftriaxone concentration above 1x MIC is 100% will be determined by calculating the ratio of the total number of patients meeting this criterion to the total number of patients included. Plasma ceftriaxone dosages will be integrated into a structural model from the scientific literature using the MonolixSuite 2023R1® package (Lixoft - Saclay) including a modeling module (Monolix) and a simulation module (Simulx). T. Individual pharmacokinetic parameters will be determined by Bayesian estimation by integrating the dosage performed in the protocol.

Locations (1)

Rouen University Hospital

Rouen, France