How ceftriaxone behaves in the body for urinary infections
Study of the Pharmacokinetics of Ceftriaxone in Urinary Tract Infections in the Emergency Department
This study tests whether a single 1 g daily dose of ceftriaxone produces effective drug levels in adults hospitalized with febrile urinary tract infections who are not in septic shock.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Rouen Academic / other |
| Locations | 1 site (Rouen) |
| Trial ID | NCT07169097 on ClinicalTrials.gov |
What this trial studies
This is an observational pharmacokinetic project enrolling adults admitted to Rouen University Hospital with a clinical diagnosis of febrile urinary tract infection who receive a prescribed 1 g IV ceftriaxone dose. Within 24 hours of the first injection, blood samples will be collected to measure total and free ceftriaxone concentrations, albumin, and bilirubin. The study will model drug exposure and calculate the probability of reaching predefined therapeutic targets across patient subgroups. Results may identify clinical and biological factors that justify dose adjustments and support personalized dosing recommendations.
Who should consider this trial
Good fit: Adults (≥18) hospitalized at Rouen University Hospital with a clinical urinary tract infection who receive a prescribed single 1 g IV dose of ceftriaxone and can provide blood samples within 24 hours are ideal candidates.
Not a fit: Patients in intensive care, with septic shock, on chronic dialysis or urgent renal replacement therapy, receiving a different ceftriaxone dose, pregnant or breastfeeding, or not hospitalized at Rouen are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the results could help personalize ceftriaxone dosing so more patients reliably reach effective antibiotic levels.
How similar studies have performed: Previous pharmacokinetic data in healthy volunteers support 1 g/day but ICU studies suggest higher doses may be needed, so similar PK approaches have produced mixed findings depending on patient severity.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Rouen
- Rouen University Hospital — Rouen, France (Recruiting)
Study contacts
- Study coordinator: Johnny JM MICHEL, Doctor
- Email: johnny.michel@chu-rouen.fr
- Phone: 02 32 88 68 59
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.