Pharmacokinetics of High-dose Ceftobiprole in Community-acquired Pneumonia Under Mechanical Ventilation.
Status:
Not yet recruiting
Trial end date:
2022-06-01
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
Centre Hospitalier Universitaire de Nīmes
Collaborators:
Centre Hospitalier Lyon Sud CHU de Nîmes Hôpital Haut-Lévêque