Antibiotic Concentrations Among Critically Ill Patients

Study Overview
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Brief Summary
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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.

Official Title
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Antibiotic Concentrations Among Critically Ill Patients

Conditions
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Administration of Antibiotics in Intensive Care Units

Intervention / Treatment
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* Biological: Blood sampling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Patients with a vein or artery catheter and who are being administered antibiotics. The latter 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. (see inclusion/exclusion criteria). | Biological: Blood sampling<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| [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). | 1/2 antibiotic dose interval (expected maximum of 4 days; days 1 to 4) | 
| [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). | 30 minutes before second antibiotic dose (expected maximum of 7 days; days 1 to 7) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apache II score |  | at time of blood sampling (day 1) | 
| SOFA score |  | at time of blood sampling (day 1) | 
| PIRO score |  | at time of blood sampling (day 1) | 
| Diagnosis at admission |  | Admission to ICU (day 1) | 
| Indication for antibiotic treatment |  | at time of blood sampling (day 1) | 
| did the patient have a surgical procedure in the last 24 hours? | yes/no | at time of blood sampling (day 1) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intensive care, antibiotic levels in blood samples