Actively Recruiting

Age: 18Years +
All Genders
NCT07169097

Study of the Pharmacokinetics of Ceftriaxone

Led by University Hospital, Rouen · Updated on 2025-09-11

300

Participants Needed

1

Research Sites

134 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Study of the Pharmacokinetics of Ceftriaxone

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 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
Not Eligible

You will not qualify if you...

  • Minor patient
  • Patient hospitalized in an intensive care unit
  • Patient with septic shock
  • Chronic dialysis or need for emergency renal replacement therapy
  • Prescription of a ceftriaxone dose 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 under judicial protection, guardianship, or curatorship

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Rouen University Hospital

Rouen, France, 76031

Actively Recruiting

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Research Team

J

Johnny JM MICHEL, Doctor

CONTACT

T

Thomas TD DUFLOT, Doctor

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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