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Clinical Trials/NCT05352997
NCT05352997CompletedNot Applicable

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

Centre Hospitalier Universitaire de Nīmes1 site in 1 country156 target enrollmentStarted: January 1, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
156
Locations
1
Primary Endpoint
To identify factors associated with adequate beta lactam plasma concentrations on the first sample

Study Overview

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 ?

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

To identify factors associated with adequate beta lactam plasma concentrations on the first sample

Time Frame: 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 Outcomes

  • 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)

Investigators

Sponsor
Centre Hospitalier Universitaire de Nīmes
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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