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Beta-lactams Therapeutic Drug Monitoring in Critically Ill Patients

NCT ID: NCT05352997

Last Updated: 2022-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

156 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2021-03-04

Brief Summary

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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 ?

Detailed Description

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Conditions

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Infectious Disease

Keywords

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beta-lactam lCU

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group 1: on-target beta-lactams serum concentration

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

No interventions assigned to this group

Group 2: off-target beta-lactams serum concentration

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

No interventions assigned to this group

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

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Claire ROGER, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

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CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

Site Status

Countries

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France

Other Identifiers

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LOCAL/2021/HG-01

Identifier Type: -

Identifier Source: org_study_id