Beta-lactams Therapeutic Drug Monitoring in Critically Ill Patients

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05352997

Acronym

SPT BETALACT

Enrollment

156

Registered

2022-04-29

Start date

2018-01-01

Completion date

2022-12-31

Last updated

2025-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infectious Disease

Keywords

beta-lactam, lCU

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 ?

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
To identify factors related with on-target beta-lactams plasma concentrations on the second sample	Day 7	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.
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.

Countries

France

Outcome results