Urinary InfectionsEtude PC-IUUNCT07169097
Study of the Pharmacokinetics of Ceftriaxone
An observational study of Urinary Infections, run by University Hospital, Rouen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Infections
- What is being tested?
- free ceftriaxone concentration dosage
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 30 Sep 2024to 30 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patient (>18 years) with clinical diagnosis of urinary tract infection requiring antibiotic therapy with ceftriaxone at a dose of 1g/24h intravenously (IV).
Who may be able to join
- 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 cannot join
- 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
Show all 9Show fewer
- Pregnant, parturient, or breastfeeding woman
- Person deprived of liberty by an administrative or judicial decision
- Person placed under judicial protection, guardianship, or curatorship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Pharmacokinetics of Ceftriaxone in Urinary Tract Infections in the Emergency Department
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.
Read the detailed description
While PK data in healthy volunteers support a single dose of ceftriaxone 1 gram/day, those from intensive care patients support 2 or even 4 grams/day. Febrile UTIs are a heterogeneous group of patients ranging from simple acute pyelonephritis in young women with no history to complex urinary tract infection in malnourished elderly patients and male urinary tract infection in elderly patients with benign prostatic hyperplasia. The present project therefore aims to evaluate whether a single dose of 1 g of ceftriaxone is sufficient to achieve the therapeutic target in all patients suffering from febrile UTI without septic shock or whether certain situations would justify a dosage adjustment. To this end, patients presenting a clinical and biological picture of UTI and having received ceftriaxone administration will be offered inclusion in this protocol. A 4 mL dry tube and a 4 mL heparinized tube will be collected for the determination of total and free ceftriaxone, albumin, and bilirubin concentrations. These samples will be added to the assessment performed as part of routine care within 24 hours of the first ceftriaxone injection. This study will calculate the probability of reaching the therapeutic target in patients treated with ceftriaxone for UTI without septic shock. Depending on the results, this study could allow the proposal of a personalized dosage of ceftriaxone for each patient suffering from urinary tract infection based on their clinical and biological parameters.
- Conditions
- Urinary Infections
- Being tested
- free ceftriaxone concentration dosage
- Keywords
- antibiotic, cephalosporin, therapeutic target, pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
free ceftriaxone concentration dosageBiological
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with urinary tract infection (UTI) for whom the time spent with a free ceftriaxone concentration
To determine the proportion of patients with UTI for whom the time spent with a free ceftriaxone concentration above 1x MIC is 100% (fT > 1x MIC = 100%). The primary objective will be evaluated by simulation using a two-compartment population pharmacokinetic model whose initial parameters will be set in accordance with the scientific literature. The residual concentration of free ceftriaxone will be used and compared to the critical concentration threshold of ceftriaxone for each pathogen defined by EUCAST (European Committee on Antimicrobial Susceptibility Testing).
Measured: within 24 hours after enrollment visit
Secondary outcomes (9)
Determine the probability of reaching the efficiency threshold fT > 1x MIC = 100% for MICs varying from 0.25 to 32 mg/L
For beta-lactams (BL) such as ceftriaxone, this is the fraction of time, fT, (expressed as a percentage between doses) where the free concentration of the antibiotic is above the minimum inhibitory concentration or MIC (%ƒT>MIC). - The probability of reaching the efficacy threshold fT > 1x MIC = 100% will be assessed using PTA (probability of target attainment) curves. Simulations will be performed using the pharmacokinetic model with different dosages and according to different MICs (from 0 to 32 mg/L).
Measured: within 24 hours after enrollment visit
Determine a mathematical function allowing the free plasma fraction of ceftriaxone to be extrapolated from the total ceftriaxone concentration
The relationship between the free and total form of plasma ceftriaxone will be studied according to a linear binding model
Measured: within 24 hours after enrollment visit
Describe the microbial epidemiology of UTIs in the Emergency Department (ED)
The microbial epidemiology of UTIs in the ED will be assessed by microbiological analysis of the ECBU of included patients collected retrospectively.
Measured: within 24 hours after enrollment visit
Determine the impact of clinical-biological variables on the pharmacokinetic profile of ceftriaxone (weight)
The weight will be that measured from the patient. This variable will be analyzed centered on the mean with and without logarithmic conversion.
Measured: within 24 hours after enrollment visit
Determine the impact of clinical-biological variables on the pharmacokinetic profile of ceftriaxone (albuminemia)
The dosages of albuminemia will be carried out using samples taken as part of the study. The variable will be analyzed centered on the mean with and without logarithmic conversion.
Measured: within 24 hours after enrollment visit
Determine the impact of clinical-biological variables on the pharmacokinetic profile of ceftriaxone (bilirubinemia)
The dosages of bilirubinemia will be carried out using samples taken as part of the study. The variable will be analyzed centered on the mean with and without logarithmic conversion.
Measured: within 24 hours after enrollment visit
Determine the impact of clinical-biological variables on the pharmacokinetic profile of ceftriaxone (creatinineemia)
The dosages of creatinineemia will be carried out using samples taken as part of the study. The variable will be analyzed centered on the mean with and without logarithmic conversion.
Measured: within 24 hours after enrollment visit
Determine a mathematical function allowing the free plasma fraction of ceftriaxone to be extrapolated from the total ceftriaxone concentration
The relationship between the free and total form of plasma ceftriaxone will be studied according to an empirical saturation model
Measured: within 24 hours after enrollment visit
Determine a mathematical function allowing the free plasma fraction of ceftriaxone to be extrapolated from the total ceftriaxone concentration
The relationship between the free and total form of plasma ceftriaxone will be studied according to different in vivo saturation models
Measured: within 24 hours after enrollment visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start30 Sep 2024
- Primary completion30 Nov 2025
- Study completion30 Dec 2025
Why it 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
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary InfectionsStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07169097
- Sponsor's protocol ID
- 2023/212/OB
- Other IDs
- 2023-A02238-37
- Acronym
- Etude PC-IUU
- Status last verified
- Mar 2026
- First submitted
- 1 Sep 2025
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data provided will be the property of the sponsor and will be used solely for its own research activities.
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Pharmacokinetics of Ceftriaxone in Urinary Tract Infections in the Emergency Department
- ClinicalTrials.gov ID
- NCT07169097
- Acronym / sponsor ID
- Etude PC-IUU / 2023/212/OB
- Conditions
- Urinary Infections
- Keywords
- antibiotic, cephalosporin, therapeutic target, pharmacokinetics
- Study type
- Observational
- Recruitment status
- TerminatedReason 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
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
While PK data in healthy volunteers support a single dose of ceftriaxone 1 gram/day, those from intensive care patients support 2 or even 4 grams/day. Febrile UTIs are a heterogeneous group of patients ranging from simple acute pyelonephritis in young women with no history to complex urinary tract infection in malnourished elderly patients and male urinary tract infection in elderly patients with benign prostatic hyperplasia. The present project therefore aims to evaluate whether a single dose of 1 g of ceftriaxone is sufficient to achieve the therapeutic target in all patients suffering from febrile UTI without septic shock or whether certain situations would justify a dosage adjustment. To this end, patients presenting a clinical and biological picture of UTI and having received ceftriaxone administration will be offered inclusion in this protocol. A 4 mL dry tube and a 4 mL heparinized tube will be collected for the determination of total and free ceftriaxone, albumin, and bilirubin concentrations. These samples will be added to the assessment performed as part of routine care within 24 hours of the first ceftriaxone injection. This study will calculate the probability of reaching the therapeutic target in patients treated with ceftriaxone for UTI without septic shock. Depending on the results, this study could allow the proposal of a personalized dosage of ceftriaxone for each patient suffering from urinary tract infection based on their clinical and biological parameters.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient (>18 years) with clinical diagnosis of urinary tract infection requiring antibiotic therapy with ceftriaxone at a dose of 1g/24h intravenously (IV).
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| free ceftriaxone concentration dosageThe 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. | Biological | – |
Primary outcome
Proportion of patients with urinary tract infection (UTI) for whom the time spent with a free ceftriaxone concentration
Time frame: within 24 hours after enrollment visit
To determine the proportion of patients with UTI for whom the time spent with a free ceftriaxone concentration above 1x MIC is 100% (fT > 1x MIC = 100%). The primary objective will be evaluated by simulation using a two-compartment population pharmacokinetic model whose initial parameters will be set in accordance with the scientific literature. The residual concentration of free ceftriaxone will be used and compared to the critical concentration threshold of ceftriaxone for each pathogen defined by EUCAST (European Committee on Antimicrobial Susceptibility Testing).
9 secondary outcomes
Determine the probability of reaching the efficiency threshold fT > 1x MIC = 100% for MICs varying from 0.25 to 32 mg/L
Time frame: within 24 hours after enrollment visit
Determine a mathematical function allowing the free plasma fraction of ceftriaxone to be extrapolated from the total ceftriaxone concentration
Time frame: within 24 hours after enrollment visit
Describe the microbial epidemiology of UTIs in the Emergency Department (ED)
Time frame: within 24 hours after enrollment visit
Determine the impact of clinical-biological variables on the pharmacokinetic profile of ceftriaxone (weight)
Time frame: within 24 hours after enrollment visit
Determine the impact of clinical-biological variables on the pharmacokinetic profile of ceftriaxone (albuminemia)
Time frame: within 24 hours after enrollment visit
Determine the impact of clinical-biological variables on the pharmacokinetic profile of ceftriaxone (bilirubinemia)
Time frame: within 24 hours after enrollment visit
Determine the impact of clinical-biological variables on the pharmacokinetic profile of ceftriaxone (creatinineemia)
Time frame: within 24 hours after enrollment visit
Determine a mathematical function allowing the free plasma fraction of ceftriaxone to be extrapolated from the total ceftriaxone concentration
Time frame: within 24 hours after enrollment visit
Determine a mathematical function allowing the free plasma fraction of ceftriaxone to be extrapolated from the total ceftriaxone concentration
Time frame: within 24 hours after enrollment visit
Results and safety
The study was stopped early (reason given: 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). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: No. The data provided will be the property of the sponsor and will be used solely for its own research activities.
Related trials for Urinary Infections
Recruiting
Diagnosis and Treatment of Urinary Tract Infection Using DNA Polymerase Chain Reaction Versus Urine Culture
Urinary Tract Infections
Active, not recruitingObservational study
Clinical Performance Evaluation of the QIAstat-Dx® cUTI Plus AMR
Complicated Urinary Tract Infection
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Recruiting
INterest of the Negative Predictive Value of Integrons in the reduCtion of Large Broad-spectrum anTibiotics Consumption for Urinary Tract infectionS
Drug Resistance, Microbial, Biomarkers
Not yet recruitingObservational study
Comparative Study of the Genomic Characteristics of Uropathogenic Escherichia Coli According to the Severity of Community-Acquired Urinary Tract Infections in Guadeloupe (COLIGENURI)
Urinary Tract Infections
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Infections, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with urinary tract infection (UTI) for whom the time spent with a free ceftriaxone concentration (time frame: within 24 hours after enrollment visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.