Antibiotic Concentrations Among Critically Ill Patients (DALI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01543334
First received: February 20, 2012
Last updated: March 3, 2014
Last verified: March 2014
  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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
  • SOFA score [ Time Frame: at time of blood sampling (day 1) ] [ Designated as safety issue: No ]
  • PIRO score [ Time Frame: at time of blood sampling (day 1) ] [ Designated as safety issue: No ]
  • Diagnosis at admission [ Time Frame: Admission to ICU (day 1) ] [ Designated as safety issue: No ]
  • Indication for antibiotic treatment [ Time Frame: at time of blood sampling (day 1) ] [ Designated as safety issue: No ]
  • did the patient have a surgical procedure in the last 24 hours? [ Time Frame: at time of blood sampling (day 1) ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: February 20, 2012
Last Updated: March 3, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

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
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on August 21, 2014