Clinical trial NCT05352997: Beta-lactams Therapeutic Drug Monitoring in Critically Ill Patients
Official title: Key Factors of Target Serum Concentrations Attainment From Beta-lactams Therapeutic Drug Monitoring in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infectious Disease
Keywords: beta-lactam
lCU
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2022-04-29
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients admitted to a critical care unit and treated for an infectious episode with beta-lactam, who received a Therapeutic Drug Monitoring. All patients older than 18 years recorded between 1/1st/2018 and 3/4th/2021 were included.

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 ?


Eligibility criteria: 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.

Primary outcomes:
measure: To identify factors associated with adequate beta lactam plasma concentrations on the first sample
timeFrame: Day 7
Secondary outcomes:
measure: To identify factors related with on-target beta-lactams plasma concentrations on the second sample
timeFrame: Day 7
measure: To identify factors related with on-target beta-lactams plasma concentrations on the second sample
timeFrame: Day 7
measure: Impact of TDM
timeFrame: Day 7
measure: To assess if beta-lactams and Aminoglycosides have the same elimination kinetic
timeFrame: Day 7
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Claire ROGER, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: