TerminatedNot Applicable

Study of the Pharmacokinetics of Ceftriaxone

Stopped: Due to difficulties encountered in patient recruitment, it was decided to discontinue this research project. Twelve patients were recruited into this trial, out of a total of 300 planned, during the 18-month enrollment period, representing a partici

France12 participantsStarted 2024-09-30

Plain-language summary

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 can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of patients with urinary tract infection (UTI) for whom the time spent with a free ceftriaxone concentration

Timeframe: within 24 hours after enrollment visit

Trial details

NCT IDNCT07169097

SponsorUniversity Hospital, Rouen

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-11-30

View on ClinicalTrials.gov More Urinary Infections trials