Antibiotic Concentrations Among Critically Ill Patients

Centre Hospitalier Universitaire de Nīmes98 enrolled

Overview

The primary objective of the DALI study is to compare antibiotic concentrations in patient blood samples with bacteriological objectives associated with maximum bactericidal activity. The antibiotics studied are certain lactams and glycopeptides.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Administration of Antibiotics in Intensive Care Units

Interventions

Blood samplingBIOLOGICAL

Blood samples will be harvested in one sequence at any time during the week set for the study. In patients receiving multiple antibiotics, multiple samples can be made (without exceeding the study of three antibiotics, ie a maximum of 6 tubes per patient). Two 3-ml tubes of blood will be collected for beta-lactams and glycopeptides (Sample A taken at half the time of the dosing interval and sample B at 30 minutes before the next dose). When patients receive continuous antibiotic treatment, both samples must be made at least 6 hours apart.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * The patient (or his/her "trusted representative") must have given his/her informed and signed consent * Antibiotic treatment is administered with beta-lactams or glycopeptides administered continuously or intermittently (Can be of the following: Amoxicillin-clavulanic acid, ampicillin, piperacillin-tazobactam, penicillin G, flucloxacillin, dicloxacillin, cloxacillin, cefazolin, ceftazidime, ceftriaxone, cefepime, meropenem, imipenem, doripenem, ertapenem; Vancomycin, teicoplanin). * A vein or artery catheter is established to facilitate blood sampling (arterial catheter is preferred) Exclusion Criteria: * None of the above-mentioned antibiotics are administered * Impossible to establish venous or arterial catheter * Consent not given * Patient is pregnant, parturient or breastfeeding * The patient is under tutorship or curatorship * The patient is participating in another study

Locations (13)

CH du Pays d'Aix

Aix-en-Provence, France

CHU d'Amiens - Hôpital Nord

Amiens, France

CHU d'Angers - Hôtel-Dieu

Angers, France

Outcomes

Primary Outcomes

[antibiotics] in blood versus bactericidal activity

The primary endpoint for the DALI study is the comparison of antibiotic concentrations in patient blood samples with bacteriological objectives associated with maximum bactericidal activity. The antibiotics studied are certain lactams (endpoint pharmacokinetics 50 and 100% T\> MIC) and glycopeptides (100% T\> 4xCMI and report ASC0-24/CMI ≥ 350).

Time frame: 1/2 antibiotic dose interval (expected maximum of 4 days; days 1 to 4)

[antibiotics] in blood versus bactericidal activity

Time frame: 30 minutes before second antibiotic dose (expected maximum of 7 days; days 1 to 7)

Secondary Outcomes

Apache II score

Time frame: at time of blood sampling (day 1)

SOFA score

Time frame: at time of blood sampling (day 1)

PIRO score

Time frame: at time of blood sampling (day 1)

Diagnosis at admission

Time frame: Admission to ICU (day 1)

Indication for antibiotic treatment

Time frame: at time of blood sampling (day 1)

did the patient have a surgical procedure in the last 24 hours?

yes/no

Data from ClinicalTrials.gov

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