Beta-lactams Therapeutic Drug Monitoring in Critically Ill Patients

Infectious Disease Clinical Trial

— SPT BETALACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05352997
• Other study ID #: LOCAL/2021/HG-01
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: March 4, 2021

Study information

• Verified date: April 2022
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 ?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: March 4, 2021
• Est. primary completion date: March 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Infectious Disease

Locations

Country	Name	City	State
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To identify factors related with on-target beta-lactams plasma concentrations on the second sample	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.	Day 7
Secondary	To identify factors related with on-target beta-lactams plasma concentrations on the second sample	Proportion of on target 2nd dosing after inadequate first dosing	Day 7
Secondary	Impact of TDM	Mean number of TDM per patient with off-target first dosing and delay to achieve target plasma concentrations.	Day 7
Secondary	To assess if beta-lactams and Aminoglycosides have the same elimination kinetic	Linkage between beta-lactams and aminoglycosides' trough concentrations for patients concurrently treated by both antibiotics.	Day 7