Beta-lactams Therapeutic Drug Monitoring in Critically Ill Patients

NCT05352997 | Completed

• 1 other identifier: LOCAL/2021/HG-01
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 1

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 ?

Conditions

Infectious Disease

Keywords

beta-lactam; lCU

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• To identify factors related with on-target beta-lactams plasma concentrations on the second sample

  Day 7

• To identify factors related with on-target beta-lactams plasma concentrations on the second sample

  Day 7

• Impact of TDM

  Day 7

• To assess if beta-lactams and Aminoglycosides have the same elimination kinetic

  Day 7

Study Arms (3)

Group 1: on-target beta-lactams serum concentration

Patients with on-target beta-lactams serum concentration during 1st dosing

Group 2: off-target beta-lactams serum concentration

Patients with off-target beta-lactams serum concentrations during 1st dosing

Group 3: off-target beta-lactams plasma concentration:

Patients with high beta-lactams plasma concentrations during 1st dosing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

Related Publications (1)

• Gandega H, Poujol H, Mezzarobba M, Muller L, Boyer JC, Lefrant JY, Leguelinel G, Roger C. Determinants of beta-lactam PK/PD target attainment in critically ill patients: A single center retrospective study. J Crit Care. 2024 Oct;83:154828. doi: 10.1016/j.jcrc.2024.154828. Epub 2024 May 17.

  PMID: 38759580 RESULT

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Claire ROGER, MD, PhD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: April 29, 2022
• Study Start: January 1, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: December 4, 2025

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)