Clinical trial NCT01543334: Antibiotic Concentrations Among Critically Ill Patients
Official title: Antibiotic Concentrations Among Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Administration of Antibiotics in Intensive Care Units
Keywords: intensive care
antibiotic levels in blood samples
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2012-03-02
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Intensive care patients with a vein or artery catheter and who are being administered antibiotics 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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: [antibiotics] in blood versus bactericidal activity
timeFrame: 1/2 antibiotic dose interval (expected maximum of 4 days; days 1 to 4)
measure: [antibiotics] in blood versus bactericidal activity
timeFrame: 30 minutes before second antibiotic dose (expected maximum of 7 days; days 1 to 7)
Secondary outcomes:
measure: Apache II score
timeFrame: at time of blood sampling (day 1)
measure: SOFA score
timeFrame: at time of blood sampling (day 1)
measure: PIRO score
timeFrame: at time of blood sampling (day 1)
measure: Diagnosis at admission
timeFrame: Admission to ICU (day 1)
measure: Indication for antibiotic treatment
timeFrame: at time of blood sampling (day 1)
measure: did the patient have a surgical procedure in the last 24 hours?
timeFrame: at time of blood sampling (day 1)
Other outcomes:
Locations:
city: Aix en Provence
country: France
facility: CH du Pays d'Aix
city: Amiens Cedex 1
country: France
facility: CHU d'Amiens - Hôpital Nord
city: Angers
country: France
facility: CHU d'Angers - Hôtel-Dieu
city: Clermont Ferrand
country: France
facility: CHU de Clermont Ferrand - Hôpital Estaing
city: Grenoble
country: France
facility: CHU de Grenoble - Hôpital A Michallon
city: Marseille Cedex 20
country: France
facility: APHM - Hôpital Nord
city: Montpellier
country: France
facility: CHU de Montpellier - Hôpital Saint-Eloi
city: Nice
country: France
facility: CHU de Nice - Hôpital St-Roch
city: Nîmes Cedex 9
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
city: Paris Cedex 18
country: France
facility: APHP - Hôpital Bichat - Claude Bernard
city: Pessac Cedex
country: France
facility: CHU de Bordeaux - Hôpital Haut-Lévêque
city: Rennes
country: France
facility: CHU de Rennes - Hôpital PontChaillou
city: Strasbourg Cedex
country: France
facility: CHRU de Strasbourg - Hôpital Civil
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Jean Yves Lefrant, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: