Beta-lactams Therapeutic Drug Monitoring in Critically Ill Patients

Completed

• Conditions: Infectious Disease

• Registration Number: NCT05352997
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

The population of these monocentric and retrospective study includes patients hospitalized in one of the critical care services of Nîmes' community hospital.

The objective is to determine the key factors that lead to satisfactory beta-lactams serum concentrations in critically ill patients.

Clinical and biological features, as well as risk scores are collected and recorded into an electronic Case Report Form.

The primary outcome is to show the main characteristics related to adequate beta-lactams serum concentrations in critically ill inpatients.

Secondary outcomes include the key factors related to inadequate beta-lactams serum concentrations in critically ill inpatients, Therapeutic Drug Monitoring (TDM) impact in the achievement of target beta-lactams serum concentration and the correlation between Aminoglycosides and Beta-lactams serum concentrations. Do both antibiotics have similar elimination kinetics ?

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2021-03-04
• Study Completion: 2021-03-04
• Status Verified: 2022-04
• Study First Submitted: 2022-04-25
• Study First Submitted QC: 2022-04-28
• Last Update Submitted: 2022-04-28
• Study First Posted: 2022-04-29
• Last Update Posted: 2022-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

• Patient aged at least (≥) 18 years of age.
• Patient (or his representative for patients unable to give their consent) has given his free and informed consent and has signed the consent form.
• Patient affiliated to the health insurance scheme
• Patient hospitalized in one of the critical care services of Nimes' community hospital with at least one beta-lactam treatment
• Patient with at least one beta-lactam TDM during his stay

Exclusion Criteria :

• Patient who did not consent the use of his personal data
• Patients under maintenance of justice, tutelage or legal guardianship
• Patient previously included in the study.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To identify factors associated with adequate beta lactam plasma concentrations on the first sample	Day 7	Determinants of adequate beta-lactams plasma concentrations using a univariate, then a multivariate analysis on patients 'characteristics at baseline and on the day of TDM

Secondary Outcome Measures

Name	Time	Method
To identify factors related with on-target beta-lactams plasma concentrations on the second sample	Day 7	Proportion of on target 2nd dosing after inadequate first dosing
Impact of TDM	Day 7	Mean number of TDM per patient with off-target first dosing and delay to achieve target plasma concentrations.
To assess if beta-lactams and Aminoglycosides have the same elimination kinetic	Day 7	Linkage between beta-lactams and aminoglycosides' trough concentrations for patients concurrently treated by both antibiotics.

Trial Locations

Locations (1)

CHU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, France