drugset / Trial / NCT04171674

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

NCT04171674

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2021-04-01
Primary completion
2023-01-04
Completion
2023-01-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Ceftobiprole Small molecule 2.5 g Other

Indications