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Beta-lactams Therapeutic Drug Monitoring in Critically Ill Patients (SPT BETALACT)

C

Centre Hospitalier Universitaire de Nīmes

Status

Completed

Conditions

Infectious Disease

Study type

Observational

Funder types

Other

Identifiers

NCT05352997
LOCAL/2021/HG-01

Details and patient eligibility

About

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 ?

Enrollment

156 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

156 participants in 3 patient groups

Group 1: on-target beta-lactams serum concentration
Description:
Patients with on-target beta-lactams serum concentration during 1st dosing
Group 2: off-target beta-lactams serum concentration
Description:
Patients with off-target beta-lactams serum concentrations during 1st dosing
Group 3: off-target beta-lactams plasma concentration:
Description:
Patients with high beta-lactams plasma concentrations during 1st dosing

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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