Antibiotic Concentrations Among Critically Ill Patients (DALI)

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.

Study Overview

• Status: Completed
• Conditions: Administration of Antibiotics in Intensive Care Units
• Intervention / Treatment: Biological: Blood sampling

• Study Type: Observational
• Enrollment (Actual): 98

Contacts and Locations

Study Locations

• France
  • Aix-en-Provence, France, 13616
    • CH du Pays D'Aix
  • Amiens, France, 80054
    • CHU d'Amiens - Hôpital Nord
  • Angers, France, 49933
    • CHU d'Angers - Hôtel-Dieu
  • Clermont-Ferrand, France, 63003
    • CHU De Clermont Ferrand - Hopital Estaing
  • Grenoble, France, 38043
    • CHU de Grenoble - Hôpital A Michallon
  • Marseille, France, 13915
    • APHM - Hopital Nord
  • Montpellier, France, 34295
    • CHU de Montpellier - Hôpital Saint-Eloi
  • Nice, France, 06006
    • CHU de Nice - Hôpital St-Roch
  • Nîmes, France, 30029
    • CHU de Nîmes - Hopital Universitaire Caremeau
  • Paris, France, 75877
    • APHP - Hopital Bichat - Claude Bernard
  • Pessac, France, 33604
    • CHU de Bordeaux - Hôpital Haut-Leveque
  • Rennes, France, 35033
    • CHU de Rennes - Hôpital Pontchaillou
  • Strasbourg, France, 67091
    • CHRU de Strasbourg - Hôpital Civil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Jean Yves Lefrant, MD PhD, Centre Hospitalier Universitaire de Nîmes

Publications and helpful links

General Publications

• Roberts JA, Paul SK, Akova M, Bassetti M, De Waele JJ, Dimopoulos G, Kaukonen KM, Koulenti D, Martin C, Montravers P, Rello J, Rhodes A, Starr T, Wallis SC, Lipman J; DALI Study. DALI: defining antibiotic levels in intensive care unit patients: are current beta-lactam antibiotic doses sufficient for critically ill patients? Clin Infect Dis. 2014 Apr;58(8):1072-83. doi: 10.1093/cid/ciu027. Epub 2014 Jan 14.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: February 20, 2012
• First Submitted That Met QC Criteria: February 27, 2012
• First Posted (Estimated): March 2, 2012

Study Record Updates

• Last Update Posted (Estimated): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: intensive care; antibiotic levels in blood samples
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: LOCAL/2011/JYL-03; 2011-A01339-32 (Other Identifier: ANSM)