Antibiotic Concentrations Among Critically Ill Patients

Completed

• Conditions: Administration of Antibiotics in Intensive Care Units

• Registration Number: NCT01543334
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-20
• Study First Submitted QC: 2012-02-27
• Study Start: 2012-03
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Study First Posted: 2012-03-02
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-25
• Last Update Posted: 2015-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
[antibiotics] in blood versus bactericidal activity	30 minutes before second antibiotic dose (expected maximum of 7 days; days 1 to 7)	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).

Secondary Outcome Measures

Name	Time	Method
PIRO score	at time of blood sampling (day 1)
Apache II score	at time of blood sampling (day 1)
SOFA 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?	at time of blood sampling (day 1)	yes/no

Trial Locations

Locations (13)

CH du Pays d'Aix; 🇫🇷 Aix en Provence, France

CHU d'Amiens - Hôpital Nord; 🇫🇷 Amiens Cedex 1, France

CHU d'Angers - Hôtel-Dieu; 🇫🇷 Angers, France

CHU de Clermont Ferrand - Hôpital Estaing; 🇫🇷 Clermont Ferrand, France

CHU de Grenoble - Hôpital A Michallon; 🇫🇷 Grenoble, France

APHM - Hôpital Nord; 🇫🇷 Marseille Cedex 20, France

CHU de Montpellier - Hôpital Saint-Eloi; 🇫🇷 Montpellier, France

CHU de Nice - Hôpital St-Roch; 🇫🇷 Nice, France

CHU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 9, France

APHP - Hôpital Bichat - Claude Bernard; 🇫🇷 Paris Cedex 18, France

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