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Antibiotic Concentrations Among Critically Ill Patients (DALI)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01543334
First Posted: March 2, 2012
Last Update Posted: March 26, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
  Purpose
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.

Condition Intervention
Administration of Antibiotics in Intensive Care Units Biological: Blood sampling

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Antibiotic Concentrations Among Critically Ill Patients

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • [antibiotics] in blood versus bactericidal activity [ Time Frame: 1/2 antibiotic dose interval (expected maximum of 4 days; days 1 to 4) ]
    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).

  • [antibiotics] in blood versus bactericidal activity [ Time Frame: 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:
  • 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? [ Time Frame: at time of blood sampling (day 1) ]
    yes/no


Enrollment: 98
Study Start Date: March 2012
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients
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
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01543334


Locations
France
CH du Pays d'Aix
Aix en Provence, France, 13616
CHU d'Amiens - Hôpital Nord
Amiens Cedex 1, France, 80054
CHU d'Angers - Hôtel-Dieu
Angers, France, 49933
CHU de Clermont Ferrand - Hôpital Estaing
Clermont Ferrand, France, 63003
CHU de Grenoble - Hôpital A Michallon
Grenoble, France, 38043
APHM - Hôpital Nord
Marseille Cedex 20, France, 13915
CHU de Montpellier - Hôpital Saint-Eloi
Montpellier, France, 34295
CHU de Nice - Hôpital St-Roch
Nice, France, 06006
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 9, France, 30029
APHP - Hôpital Bichat - Claude Bernard
Paris Cedex 18, France, 75877
CHU de Bordeaux - Hôpital Haut-Lévêque
Pessac Cedex, France, 33604
CHU de Rennes - Hôpital PontChaillou
Rennes, France, 35033
CHRU de Strasbourg - Hôpital Civil
Strasbourg Cedex, France, 67091
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Jean Yves Lefrant, MD PhD Centre Hospitalier Universitaire de Nîmes
  More Information

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01543334     History of Changes
Other Study ID Numbers: LOCAL/2011/JYL-03
2011-A01339-32 ( Other Identifier: RCB number )
First Submitted: February 20, 2012
First Posted: March 2, 2012
Last Update Posted: March 26, 2015
Last Verified: March 2015

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
intensive care
antibiotic levels in blood samples

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents