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

NCT04171674 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-12-05

No results posted yet for this study

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

Interventions

DRUG

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.

Sponsors & Collaborators

  • Centre Hospitalier Lyon Sud

    collaborator OTHER

  • Hôpital Haut-Lévêque

    collaborator OTHER

  • Centre Hospitalier Universitaire de Nīmes

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04171674 on ClinicalTrials.gov