Pharmacokinetics of High-dose Ceftobiprole in Community-acquired Pneumonia Under Mechanical Ventilation.

NCT04171674 | Completed

• 2 other identifiers: CIVI/2018/CR-012019-002027-15
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Pneumonia

Keywords

community-acquired pneumonia

Outcome Measures

Primary Outcomes (10)

• 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

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Day 3 at Time 12

Secondary Outcomes (31)

• Pulmonary concentration of ceftobiprole on Day 3

  On Day 3 of treatment with ceftobiprole

• Plasma concentration BEFORE treatment

  Day 1

• Plasma concentration AFTER maximum dose of ceftobiprole on Day 1

  Day 1

• Plasma concentration after two hours at the steady-state

  Day 1

• Plasma concentration after 6 hours at the steady-state

  Day 1

Study Arms (1)

Patients treated with high-dose ceftobiprole

EXPERIMENTAL

Drug: Treatment with high-dose ceftobiprole (500mg loading dose followed by 2.5g under continuos infusion).

Interventions

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.

Patients treated with high-dose ceftobiprole

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Any patient who is already taking part in another interventional study that may influence the main criterion for judgement.
• 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
• 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.

Sponsors & Collaborators

• Centre Hospitalier Lyon Sud: collaborator
• Hôpital Haut-Lévêque: collaborator
• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (2)

Centre Hospitalier Lyon Sud,

Pierre-Bénite, Auvergne-Rhône-Alpes, 69310, France

Location

CHU de Nîmes

Nîmes, Gard, 30029, France

Location

Related Publications (1)

• 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.

  PMID: 40754699 RESULT

MeSH Terms

Conditions

Pneumonia; Community-Acquired Pneumonia

Interventions

Therapeutics; ceftobiprole

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Community-Acquired Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: November 21, 2019
• Study Start: April 1, 2021
• Primary Completion: January 4, 2023
• Study Completion: January 4, 2023
• Last Updated: December 5, 2025

Record last verified: 2025-12

Locations

FR (2)