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

• Status: Not yet recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes
• Collaborators: Centre Hospitalier Lyon Sud; CHU de Nîmes; Hôpital Haut-Lévêque
• Treatments: Ceftobiprole; Ceftobiprole medocaril; Cephalosporins

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

• 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.