PneumoniaPAC CEFNCT04171674
Pharmacokinetics of High-dose Ceftobiprole in Community-acquired Pneumonia Under Mechanical Ventilation.
A study testing Treatment with high-dose ceftobiprole (500mg loading dose followed by 2.5g under continuos infusion). in people with Pneumonia, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
Trial summary
The main aim of the study is to describe plasma pharmacokinetics (PK) and pulmonary diffusion of high-dose ceftobiprole (500 mg loading dose followed by 2.5 g under continuous infusion for 24h) for mechanically-ventilated adult patients with severe community-acquired pneumonia, using population PK modelling. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia
- What is being tested?
- Treatment with high-dose ceftobiprole (500mg loading dose followed by 2.5g under continuos infusion).
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Apr 2021to 4 Jan 2023
- Phase
- Interventional
- 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
Who may be able to join
- All patients (or his/her representative for those patients who are unable to express their consent) who have given free, informed consent, and signed the consent form.
- All patients affiliated to or benefitting from a health insurance scheme.
- All patients hospitalised in the intensive care unit with severe acute community-acquired pneumonia requiring the use of mechanical ventilation: this is characterised by signs and symptoms corresponding to an infection of the lower respiratory tract and imaging data corresponding to bacterial pneumonia.The patient has been under mechanical ventilation for less than 24 hours.
Who cannot join
- Any patient who is already taking part in another interventional study that may influence the main criterion for judgement.
- Any patient who is in the exclusion period determined by another study.
- Any patient under curatorship or guardianship established by a court
- Any patient who is pregnant, about to give birth or breastfeeding.
- Any patient with a contra-indication or allergy to beta-lactams
- Any patient whose survival is estimated at less than 48 hours
Show all 9Show fewer
- Any patient whose discharge from hospital is planned for 24 hours after admission
- Any patient whose creatinine clearance is estimated at less than 50 ml/min or who is undergoing renal replacement therapy
- Any patient undergoing extracorporeal life support.
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU de Nîmes
Nîmes, Gard, 30029
Centre Hospitalier Lyon Sud,
Pierre-Bénite, Auvergne-Rhône-Alpes, 69310
About this study
Official title: A Study on Plasma and Pulmonary Pharmacokinetics of High-dose Ceftobiprole Given by Continuous Infusion in Mechanically-ventilated Adult Patients With Severe Community-acquired Pneumonia
The main aim of the study is to describe plasma pharmacokinetics (PK) and pulmonary diffusion of high-dose ceftobiprole (500 mg loading dose followed by 2.5 g under continuous infusion for 24h) for mechanically-ventilated adult patients with severe community-acquired pneumonia, using population PK modelling.
The secondary aims are :
Read more
A- To determine whether the pharmacokinetic / pharmacodynamic (PK/PD) targets can be achieved in the plasma and epithelial lining fluid with the recommended doses of ceftobiprole.
B- To define the optimal dose regimen for ceftobiprole in this population.
C- To evaluate clinical recovery (at Day 3 and Day 8) and microbiological recovery (at Day 3).
D- To evaluate the clinical evolution.
E- To evaluate the clinical and biological tolerance.
Read the detailed description
Pneumonia is still associated with high morbi-mortality, and rapid treatment with suitable antibiotics is required, i.e. with a broad enough spectrum to cover the activity of all the potentially-incriminated pathogens. These antibiotics must be administered at efficient doses and diffused in sufficient quantity at the infection site.
Unlike other beta-lactams, ceftobiprole is a new-generation broad-spectrum cephalosporin which is active on the majority of pathogens encountered in acute, community-acquired pneumonia (CAP) and also on methicillin-resistant staphylococcus aureus (MRSA) and non-fermenting Gram-negative bacilli (GNB) like pseudomonas aeruginosa. It is indicated for the treatment of CAP and also healthcare-associated pneumonia, other than that acquired under mechanical ventilation.
For any antibiotic administered to critically ill patients it is necessary to ensure that the pharmacokinetic/pharmacodynamic (PK/PD) targets correlated with clinical efficacy can be reached with the recommended doses. The DALI study published in 2014 was the first study to alert on the risk of plasma under-dosing when the standard doses of beta lactams were administered in severely ill patients.
Since then, several PK studies performed in the intensive care unit have confirmed the significant risk of non-optimal doses in this population, linked to physiopathological alterations caused by sepsis. So far there have been no studies specifically aimed at the pharmacokinetics of ceftobiprole in those patients with CAP requiring mechanical ventilation. Furthermore, although there is increasing use in the pharmaceutical industry and in the post-developmental phases of medicines, a population PK analysis to help describe the factors influencing the PK of a molecule and establish new dose regimens optimised for a given population (in this case an ICU population) using Monte Carlo simulations, has never been developed for ceftobiprole given by continuous infusion.
The ultimate aim of so-called adequate antibiotic therapy is to obtain the right therapeutic concentrations at the infection site. During a pulmonary infection, the targeted concentrations of antibiotics in the alveolar liquid must be above the minimal inhibitory concentration value at the end of the dose interval for so-called " time-dependent " antibiotics like cephalosporins. Obtaining these efficient concentrations is often made difficult by the beta-lactams' mediocre pulmonary diffusion and can require an increase in doses in order to reach the PK/PD target at the infection site and/or the use of continuous administration of beta-lactamines. Indeed, this way of administrating is being privileged more and more in order to optimise the time spent above the minimal inhibitory concentration.
This pharmacokinetic study is the first to be carried out among a population of ICU patients and one that focuses on pulmonary diffusion of ceftobiprole for the treatment of severe CAP. The main benefits expected are to determine the most suitable doses of ceftobiprole when this molecule is used to treat ICU patients suffering from CAP. With the help of this population analysis, the main aim of the study is therefore to describe the pharmacokinetics (PK) of the plasma and pulmonary diffusion of ceftobiprole administered at high-dosage (500 mg loading dose followed by 2.5 g under continuous infusion for 24h) for severe community-acquired pneumonia under mechanical ventilation.
The secondary aims are :
A- Determine whether the pharmacokinetic / pharmacodynamic (PK/PD) targets can be achieved in the plasma and epithelial lining fluid with the recommended doses of ceftobiprole.
B- Define the optimal dose regimen for ceftobiprole in this population. C- Evaluate the clinical recovery (at Day 3 and Day 8) and microbiological recovery (at Day 3).
D- Evaluate the clinical evolution. E- Evaluate the clinical and biological tolerance.
- Conditions
- Pneumonia
- Being tested
- Treatment with high-dose ceftobiprole (500mg loading dose followed by 2.5g under continuos infusion).
- Keywords
- community-acquired pneumonia
- Medical subject headings
- Pneumonia, Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with high-dose ceftobiprole (500mg loading dose followed by 2.5g under continuos infusion).Drug
High-dose ceftobiprole (500mg loading dose) will be administered to patients for 30 minutes followed by 2.5g under continuous infusion for 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with high-dose ceftobiprole | Experimental | Not described Receives: Drug: Treatment with high-dose ceftobiprole (500mg loading dose followed by 2.5g under continuos infusion). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of ceftobiprole on Day 1
A blood test is performed upon admission to the Intensive Care Unit, BEFORE beginning antibiotic therapy with Ceftobiprole
Measured: Day 1
Blood test after injection of loading-dose Ceftobiprole (Cmax) for 30 minutes
A 3ml blood sample is taken after injection of 500g of Ceftobiprole for 30 minutes, for pharmacological dosage.
Measured: Day 1 (after the 30-minute injection)
Blood test 2 hours AFTER beginning antibiotic therapy with ceftobiprole
After injection of loading-dose Ceftobiprole (Cmax) for 30 minutes followed by 2.5g by continuous infusion of ceftobiprole, a sample is taken at 2 hours from the start of treatment.
Measured: Day 1, 2 hours from start of treatment
Blood test 6 hours AFTER beginning antibiotic therapy with ceftobiprole
After injection of loading-dose Ceftobiprole (Cmax) for 30 minutes followed by 2.5g by continuous infusion of ceftobiprole, a sample is taken at 6 hours from the start of treatment.
Measured: Day 1, 6 hours from start of treatment
Blood test 8 hours AFTER beginning antibiotic therapy with ceftobiprole
After injection of loading-dose Ceftobiprole (Cmax) for 30 minutes followed by 2.5g by continuous infusion of ceftobiprole, a sample is taken at 8 hours from the start of treatment.
Measured: Day 1, 8 hours from start of treatment
Blood test 12 hours AFTER beginning antibiotic therapy with ceftobiprole
After injection of loading-dose Ceftobiprole (Cmax) for 30 minutes followed by 2.5g by continuous infusion of ceftobiprole, a sample is taken at 12 hours from the start of treatment.
Measured: Day 1, 12 hours from start of treatment
Time 2 blood test on third day of antibiotic therapy with ceftobiprole
Patient is on 2.5g of ceftobiprole by continuous infusion. Samples are taken at regular intervals on Day 3.
Measured: Day 3 at Time 2
Time 6 blood test on third day of antibiotic therapy with ceftobiprole
Patient is on 2.5g of ceftobiprole by continuous infusion. Samples are taken at regular intervals on Day 3.
Measured: Day 3 at Time 6
Time 8 blood test on third day of antibiotic therapy with ceftobiprole
Patient is on 2.5g of ceftobiprole by continuous infusion. Samples are taken at regular intervals on Day 3.
Measured: Day 3 at Time 8
Time 12 blood test on third day of antibiotic therapy with ceftobiprole
Patient is on 2.5g of ceftobiprole by continuous infusion. Samples are taken at regular intervals on Day 3.
Measured: Day 3 at Time 12
Secondary outcomes (31)
Pulmonary concentration of ceftobiprole on Day 3
Pulmonary concentrations of ceftobiprole are measured by bronchoalveolar lavage at the same time as any one of the blood samples are taken on Day 3
Measured: On Day 3 of treatment with ceftobiprole
Plasma concentration BEFORE treatment
A blood test is performed upon admission to the Intensive Care Unit, BEFORE beginning antibiotic therapy with Ceftobiprole to evaluate plasma concentration.
Measured: Day 1
Plasma concentration AFTER maximum dose of ceftobiprole on Day 1
Patient has now begun antibiotic therapy with Ceftobiprole and has been injected with 500g of Ceftobiprole for 30 minutes. A blood sample is taken to evaluate plasma concentration.
Measured: Day 1
Plasma concentration after two hours at the steady-state
The dosage of Ceftobiprole has now been reduced. Patient is on 2.5g of ceftobiprole by continuous infusion and plasma concentration is measured after 2 hours.
Measured: Day 1
Plasma concentration after 6 hours at the steady-state
Patient is on 2.5g of ceftobiprole by continuous infusion and plasma concentration is measured after 6 hours.
Measured: Day 1
Plasma concentration after 8 hours at the steady-state
Patient is on 2.5g of ceftobiprole by continuous infusion and plasma concentration is measured after 8 hours.
Measured: Day 1
Plasma concentration after 12 hours at the steady-state
Patient is on 2.5g of ceftobiprole by continuous infusion and plasma concentration is measured after 12 hours.
Measured: Day 1
Plasma concentration at Time 2 on Day 2 of the steady-state
Patient is on 2.5g of ceftobiprole by continuous infusion and plasma concentration is measured at Time 2
Measured: Day 2 at Time 2
Plasma concentration at Time 6 on Day 2 of the steady-state
Patient is on 2.5g of ceftobiprole by continuous infusion and plasma concentration is measured at Time 6
Measured: Day 2 at Time 6
Plasma concentration at Time 8 on Day 2 of the steady-state
Patient is on 2.5g of ceftobiprole by continuous infusion and plasma concentration is measured at Time 8
Measured: Day 2 at Time 8
Plasma concentration at Time 12 on Day 2 of the steady-state
Patient is on 2.5g of ceftobiprole by continuous infusion and plasma concentration is measured at Time 12
Measured: Day 2 at Time 12
Plasma concentration on Day 3 (after end of 24H infusion with ceftobiprole)
3ml blood samples are taken and plasma concentration is measured at regular intervals
Measured: Day 3 at Time 2
Plasma concentration on Day 3 (after end of 24H infusion with ceftobiprole)
3ml blood samples are taken and plasma concentration is measured at regular intervals
Measured: Day 3 at Time 6
Plasma concentration on Day 3 (after end of 24H infusion with ceftobiprole)
3ml blood samples are taken and plasma concentration is measured at regular intervals
Measured: Day 3 at Time 8
Plasma concentration on Day 3 (after end of 24H infusion with ceftobiprole)
3ml blood samples are taken and plasma concentration is measured at regular intervals
Measured: Day 3 at Time 12
Presence or not of Ceftobiprole in the epithelial lining fluid on Day 3 (after end of 24H infusion with ceftobiprole)
A sample of epithelial lining fluid is taken on Day 3 by bronchoalveolar lavage and analyzed.
Measured: Day 3
Dose regimens defined by Monte Carlo simulations
Qualitative, pharmacokinetic modelisation using Pmetrics(r) software
Measured: After day 3
Test of cure on Day 3
The clinician in charge of the patient evaluates the clinical response as follows :
Resolution:All signs and symptoms related to infection have disappeared Improvement: Marked or moderate reduction of the seriousness and/or number of signs and symptoms of the infection.
Failure: Insufficient decrease in signs and symptoms related to the infection. No change in patient's condition. Death, even undetermined.
Measured: Day 3
Test of cure on Day 8
The clinician in charge of the patient evaluates the clinical response as follows :
Resolution:All signs and symptoms related to infection have disappeared Improvement: Marked or moderate reduction of the seriousness and/or number of signs and symptoms of the infection.
Failure: Insufficient decrease in signs and symptoms related to the infection. No change in patient's condition. Death, even undetermined.
Measured: Day 8
Test of microbiological cure on Day 3
Descriptive and quantitative analysis on a cultivated sample taken via bronchoalveolar lavage on Day 3 to check for presence or not of ceftobiprole in the epithelial lining fluid.
Measured: Day 3
Duration of stay at the intensive care unit.
28 days from the beginning of treatment, the number of days that the patient spent in the ICU are noted in the patient's medical file.
Measured: Day 28
Vital status
28 days from the beginning of treatment, the patient's vital status is noted in the patient's medical file (dead/alive).
Measured: Day 28
Number of days alive without mechanical ventilation
28 days from the beginning of treatment, the number of days that the patient has remained alive without mechanical ventilation is noted from the patient's medical file.
Measured: Day 28
Renal function on Day 1
Creatinine clearance is measured in ML/min to evaluate the patient's renal function
Measured: Day 1
Renal function on Day 2
Creatinine clearance is measured in ML/min to evaluate the patient's renal function
Measured: Day 2
Evaluation of renal function on Day 3
Creatinine clearance is measured in ML/min to evaluate the patient's renal function
Measured: Day 3
Evaluation of renal function on Day 8
Creatinine clearance is measured in ML/min to evaluate the patient's renal function
Measured: Day 8
Evaluation of liver function on Day 1
The following measurements are taken in order to evaluate the patient's liver function: albumin level (in g/L) and transaminase doses (ALAT, ASAT).
Measured: Day 1
Evaluation of liver function on Day 2
The following measurements are taken in order to evaluate the patient's liver function: albumin level (in g/L) and transaminase doses (ALAT, ASAT).
Measured: Day 2
Evaluation of liver function on Day 3
The following measurements are taken in order to evaluate the patient's liver function: albumin level (in g/L) and transaminase doses (ALAT, ASAT).
Measured: Day 3
Evaluation of liver function on Day 8
The following measurements are taken in order to evaluate the patient's liver function: albumin level (in g/L) and transaminase doses (ALAT, ASAT).
Measured: Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start1 Apr 2021
- Primary completion4 Jan 2023
- Study completion4 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Lyon Sud, Hôpital Haut-Lévêque
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04171674
- Sponsor's protocol ID
- CIVI/2018/CR-01
- Other IDs
- 2019-002027-15, 2019
- Acronym
- PAC CEF
- Status last verified
- Dec 2025
- First submitted
- 19 Nov 2019
- Last updated
- 5 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Roger C, Allaouchiche B, Quintao De Moraes D, Ulrich Feudjio O, Occean BV, Friggeri A, Lefrant JY, Muller L, Breilh D. Intrapulmonary concentrations of ceftobiprole high doses administered by continuous infusion in critically ill patients with community-acquired pneumonia. J Antimicrob Chemother. 2025 Oct 3;80(10):2644-2653. doi: 10.1093/jac/dkaf267.
PubMed 40754699
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Plasma and Pulmonary Pharmacokinetics of High-dose Ceftobiprole Given by Continuous Infusion in Mechanically-ventilated Adult Patients With Severe Community-acquired Pneumonia
- ClinicalTrials.gov ID
- NCT04171674
- Acronym / sponsor ID
- PAC CEF / CIVI/2018/CR-01
- Conditions
- Pneumonia
- Keywords
- community-acquired pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Collaborators
- Centre Hospitalier Lyon Sud, Hôpital Haut-Lévêque
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 4 Jan 2023 (actual)
- Study completion
- 4 Jan 2023 (actual)
- First posted
- 21 Nov 2019 (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.
The main aim of the study is to describe plasma pharmacokinetics (PK) and pulmonary diffusion of high-dose ceftobiprole (500 mg loading dose followed by 2.5 g under continuous infusion for 24h) for mechanically-ventilated adult patients with severe community-acquired pneumonia, using population PK modelling.
The secondary aims are :
A- To determine whether the pharmacokinetic / pharmacodynamic (PK/PD) targets can be achieved in the plasma and epithelial lining fluid with the recommended doses of ceftobiprole.
B- To define the optimal dose regimen for ceftobiprole in this population.
C- To evaluate clinical recovery (at Day 3 and Day 8) and microbiological recovery (at Day 3).
D- To evaluate the clinical evolution.
E- To evaluate the clinical and biological tolerance.
Detailed description
Pneumonia is still associated with high morbi-mortality, and rapid treatment with suitable antibiotics is required, i.e. with a broad enough spectrum to cover the activity of all the potentially-incriminated pathogens. These antibiotics must be administered at efficient doses and diffused in sufficient quantity at the infection site.
Unlike other beta-lactams, ceftobiprole is a new-generation broad-spectrum cephalosporin which is active on the majority of pathogens encountered in acute, community-acquired pneumonia (CAP) and also on methicillin-resistant staphylococcus aureus (MRSA) and non-fermenting Gram-negative bacilli (GNB) like pseudomonas aeruginosa. It is indicated for the treatment of CAP and also healthcare-associated pneumonia, other than that acquired under mechanical ventilation.
For any antibiotic administered to critically ill patients it is necessary to ensure that the pharmacokinetic/pharmacodynamic (PK/PD) targets correlated with clinical efficacy can be reached with the recommended doses. The DALI study published in 2014 was the first study to alert on the risk of plasma under-dosing when the standard doses of beta lactams were administered in severely ill patients.
Since then, several PK studies performed in the intensive care unit have confirmed the significant risk of non-optimal doses in this population, linked to physiopathological alterations caused by sepsis. So far there have been no studies specifically aimed at the pharmacokinetics of ceftobiprole in those patients with CAP requiring mechanical ventilation. Furthermore, although there is increasing use in the pharmaceutical industry and in the post-developmental phases of medicines, a population PK analysis to help describe the factors influencing the PK of a molecule and establish new dose regimens optimised for a given population (in this case an ICU population) using Monte Carlo simulations, has never been developed for ceftobiprole given by continuous infusion.
The ultimate aim of so-called adequate antibiotic therapy is to obtain the right therapeutic concentrations at the infection site. During a pulmonary infection, the targeted concentrations of antibiotics in the alveolar liquid must be above the minimal inhibitory concentration value at the end of the dose interval for so-called " time-dependent " antibiotics like cephalosporins. Obtaining these efficient concentrations is often made difficult by the beta-lactams' mediocre pulmonary diffusion and can require an increase in doses in order to reach the PK/PD target at the infection site and/or the use of continuous administration of beta-lactamines. Indeed, this way of administrating is being privileged more and more in order to optimise the time spent above the minimal inhibitory concentration.
This pharmacokinetic study is the first to be carried out among a population of ICU patients and one that focuses on pulmonary diffusion of ceftobiprole for the treatment of severe CAP. The main benefits expected are to determine the most suitable doses of ceftobiprole when this molecule is used to treat ICU patients suffering from CAP. With the help of this population analysis, the main aim of the study is therefore to describe the pharmacokinetics (PK) of the plasma and pulmonary diffusion of ceftobiprole administered at high-dosage (500 mg loading dose followed by 2.5 g under continuous infusion for 24h) for severe community-acquired pneumonia under mechanical ventilation.
The secondary aims are :
A- Determine whether the pharmacokinetic / pharmacodynamic (PK/PD) targets can be achieved in the plasma and epithelial lining fluid with the recommended doses of ceftobiprole.
B- Define the optimal dose regimen for ceftobiprole in this population. C- Evaluate the clinical recovery (at Day 3 and Day 8) and microbiological recovery (at Day 3).
D- Evaluate the clinical evolution. E- Evaluate the clinical and biological tolerance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with high-dose ceftobiprole | Experimental | Drug: Treatment with high-dose ceftobiprole (500mg loading dose followed by 2.5g under continuos infusion). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients (or his/her representative for those patients who are unable to express their consent) who have given free, informed consent, and signed the consent form.
- All patients affiliated to or benefitting from a health insurance scheme.
- All patients hospitalised in the intensive care unit with severe acute community-acquired pneumonia requiring the use of mechanical ventilation: this is characterised by signs and symptoms corresponding to an infection of the lower respiratory tract and imaging data corresponding to bacterial pneumonia.The patient has been under mechanical ventilation for less than 24 hours.
Key exclusion criteria (9 listed)
- Any patient who is already taking part in another interventional study that may influence the main criterion for judgement.
- Any patient who is in the exclusion period determined by another study.
- Any patient under curatorship or guardianship established by a court
- Any patient who is pregnant, about to give birth or breastfeeding.
- Any patient with a contra-indication or allergy to beta-lactams
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 |
|---|---|---|
| Treatment with high-dose ceftobiprole (500mg loading dose followed by 2.5g under continuos infusion).High-dose ceftobiprole (500mg loading dose) will be administered to patients for 30 minutes followed by 2.5g under continuous infusion for 24 hours. | Drug | Patients treated with high-dose ceftobiprole |
Primary outcome
Plasma concentration of ceftobiprole on Day 1
Time frame: Day 1
A blood test is performed upon admission to the Intensive Care Unit, BEFORE beginning antibiotic therapy with Ceftobiprole
Blood test after injection of loading-dose Ceftobiprole (Cmax) for 30 minutes
Time frame: Day 1 (after the 30-minute injection)
A 3ml blood sample is taken after injection of 500g of Ceftobiprole for 30 minutes, for pharmacological dosage.
Blood test 2 hours AFTER beginning antibiotic therapy with ceftobiprole
Time frame: Day 1, 2 hours from start of treatment
After injection of loading-dose Ceftobiprole (Cmax) for 30 minutes followed by 2.5g by continuous infusion of ceftobiprole, a sample is taken at 2 hours from the start of treatment.
Blood test 6 hours AFTER beginning antibiotic therapy with ceftobiprole
Time frame: Day 1, 6 hours from start of treatment
After injection of loading-dose Ceftobiprole (Cmax) for 30 minutes followed by 2.5g by continuous infusion of ceftobiprole, a sample is taken at 6 hours from the start of treatment.
Blood test 8 hours AFTER beginning antibiotic therapy with ceftobiprole
Time frame: Day 1, 8 hours from start of treatment
After injection of loading-dose Ceftobiprole (Cmax) for 30 minutes followed by 2.5g by continuous infusion of ceftobiprole, a sample is taken at 8 hours from the start of treatment.
Blood test 12 hours AFTER beginning antibiotic therapy with ceftobiprole
Time frame: Day 1, 12 hours from start of treatment
After injection of loading-dose Ceftobiprole (Cmax) for 30 minutes followed by 2.5g by continuous infusion of ceftobiprole, a sample is taken at 12 hours from the start of treatment.
Time 2 blood test on third day of antibiotic therapy with ceftobiprole
Time frame: Day 3 at Time 2
Patient is on 2.5g of ceftobiprole by continuous infusion. Samples are taken at regular intervals on Day 3.
Time 6 blood test on third day of antibiotic therapy with ceftobiprole
Time frame: Day 3 at Time 6
Patient is on 2.5g of ceftobiprole by continuous infusion. Samples are taken at regular intervals on Day 3.
Time 8 blood test on third day of antibiotic therapy with ceftobiprole
Time frame: Day 3 at Time 8
Patient is on 2.5g of ceftobiprole by continuous infusion. Samples are taken at regular intervals on Day 3.
Time 12 blood test on third day of antibiotic therapy with ceftobiprole
Time frame: Day 3 at Time 12
Patient is on 2.5g of ceftobiprole by continuous infusion. Samples are taken at regular intervals on Day 3.
31 secondary outcomes
Pulmonary concentration of ceftobiprole on Day 3
Time frame: On Day 3 of treatment with ceftobiprole
Plasma concentration BEFORE treatment
Time frame: Day 1
Plasma concentration AFTER maximum dose of ceftobiprole on Day 1
Time frame: Day 1
Plasma concentration after two hours at the steady-state
Time frame: Day 1
Plasma concentration after 6 hours at the steady-state
Time frame: Day 1
Plasma concentration after 8 hours at the steady-state
Time frame: Day 1
Plasma concentration after 12 hours at the steady-state
Time frame: Day 1
Plasma concentration at Time 2 on Day 2 of the steady-state
Time frame: Day 2 at Time 2
Plasma concentration at Time 6 on Day 2 of the steady-state
Time frame: Day 2 at Time 6
Plasma concentration at Time 8 on Day 2 of the steady-state
Time frame: Day 2 at Time 8
Plasma concentration at Time 12 on Day 2 of the steady-state
Time frame: Day 2 at Time 12
Plasma concentration on Day 3 (after end of 24H infusion with ceftobiprole)
Time frame: Day 3 at Time 2
Plasma concentration on Day 3 (after end of 24H infusion with ceftobiprole)
Time frame: Day 3 at Time 6
Plasma concentration on Day 3 (after end of 24H infusion with ceftobiprole)
Time frame: Day 3 at Time 8
Plasma concentration on Day 3 (after end of 24H infusion with ceftobiprole)
Time frame: Day 3 at Time 12
Presence or not of Ceftobiprole in the epithelial lining fluid on Day 3 (after end of 24H infusion with ceftobiprole)
Time frame: Day 3
Dose regimens defined by Monte Carlo simulations
Time frame: After day 3
Test of cure on Day 3
Time frame: Day 3
Test of cure on Day 8
Time frame: Day 8
Test of microbiological cure on Day 3
Time frame: Day 3
Duration of stay at the intensive care unit.
Time frame: Day 28
Vital status
Time frame: Day 28
Number of days alive without mechanical ventilation
Time frame: Day 28
Renal function on Day 1
Time frame: Day 1
Renal function on Day 2
Time frame: Day 2
Evaluation of renal function on Day 3
Time frame: Day 3
Evaluation of renal function on Day 8
Time frame: Day 8
Evaluation of liver function on Day 1
Time frame: Day 1
Evaluation of liver function on Day 2
Time frame: Day 2
Evaluation of liver function on Day 3
Time frame: Day 3
Evaluation of liver function on Day 8
Time frame: Day 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Results publication: PubMed 40754699Roger C, Allaouchiche B, Quintao De Moraes D, Ulrich Feudjio O, Occean BV, Friggeri A, Lefrant JY, Muller L, Breilh D. Intrapulmonary concentrations of ceftobiprole high doses administered by continuous infusion in critically ill patients with community-acquired pneumonia. J Antimicrob Chemother. 2025 Oct 3;80(10):2644-2653. doi: 10.1093/jac/dkaf267.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment with high-dose ceftobiprole (500mg loading dose followed by 2.5g under continuos infusion). in people with Pneumonia, run by Centre Hospitalier Universitaire de Nīmes at 2 sites 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 3 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: finished, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Plasma concentration of ceftobiprole on Day 1 (time frame: Day 1). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04171674, which also lists 1 linked publication.
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 5 Dec 2025.