Beta-lactams Therapeutic Drug Monitoring in Critically Ill Patients

Study Overview
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Brief Summary
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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 ?

Official Title
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Key Factors of Target Serum Concentrations Attainment From Beta-lactams Therapeutic Drug Monitoring in Critically Ill Patients

Conditions
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Infectious Disease

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1: on-target beta-lactams serum concentration<br>Patients with on-target beta-lactams serum concentration during 1st dosing | |
| Group 2: off-target beta-lactams serum concentration<br>Patients with off-target beta-lactams serum concentrations during 1st dosing | |
| Group 3: off-target beta-lactams plasma concentration:<br>Patients with high beta-lactams plasma concentrations during 1st dosing | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify factors associated with adequate beta lactam plasma concentrations on the first sample | 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 | Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify factors related with on-target beta-lactams plasma concentrations on the second sample | Risk factors of inadequate beta-lactam plasma concentrations using a univariate, then a multivariate analysis on patients 'characteristics at baseline and on the day of TDM. | Day 7 | 
| To identify factors related with on-target beta-lactams plasma concentrations on the second sample | Proportion of on target 2nd dosing after inadequate first dosing | Day 7 | 
| Impact of TDM | Mean number of TDM per patient with off-target first dosing and delay to achieve target plasma concentrations. | Day 7 | 
| To assess if beta-lactams and Aminoglycosides have the same elimination kinetic | Linkage between beta-lactams and aminoglycosides' trough concentrations for patients concurrently treated by both antibiotics. | Day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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beta-lactam, lCU