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Completed

NCT Number: NCT05352997

Beta-lactams Therapeutic Drug Monitoring in Critically Ill Patients

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 ?

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Key information

Conditions

Infectious Disease Communicable Diseases Disease Attributes Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

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

    Time frame: 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.

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

    Time frame: Day 7

    Proportion of on target 2nd dosing after inadequate first dosing

  3. Impact of TDM

    Time frame: Day 7

    Mean number of TDM per patient with off-target first dosing and delay to achieve target plasma concentrations.

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

    Time frame: Day 7

    Linkage between beta-lactams and aminoglycosides' trough concentrations for patients concurrently treated by both antibiotics.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Acronym: SPT BETALACT

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Apr 29, 2022
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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