Antibiotic Concentrations Among Critically Ill Patients

NCT01543334 | Completed

• 2 other identifiers: LOCAL/2011/JYL-032011-A01339-32
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 13

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.

Conditions

Administration of Antibiotics in Intensive Care Units

Keywords

intensive care; antibiotic levels in blood samples

Outcome Measures

Primary Outcomes (2)

• [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 Outcomes (6)

• 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)

Study Arms (1)

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

Interventions

Blood sampling BIOLOGICAL

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.

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (13)

CH du Pays d'Aix

Aix-en-Provence, 13616, France

Location

CHU d'Amiens - Hôpital Nord

Amiens, 80054, France

Location

CHU d'Angers - Hôtel-Dieu

Angers, 49933, France

Location

CHU de Clermont Ferrand - Hôpital Estaing

Clermont-Ferrand, 63003, France

Location

CHU de Grenoble - Hôpital A Michallon

Grenoble, 38043, France

Location

APHM - Hôpital Nord

Marseille, 13915, France

Location

CHU de Montpellier - Hôpital Saint-Eloi

Montpellier, 34295, France

Location

CHU de Nice - Hôpital St-Roch

Nice, 06006, France

Location

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

APHP - Hôpital Bichat - Claude Bernard

Paris, 75877, France

Location

CHU de Bordeaux - Hôpital Haut-Lévêque

Pessac, 33604, France

Location

CHU de Rennes - Hôpital PontChaillou

Rennes, 35033, France

Location

CHRU de Strasbourg - Hôpital Civil

Strasbourg, 67091, France

Location

Related Publications (1)

• 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.

  PMID: 24429437 RESULT

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Jean Yves Lefrant, MD PhD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2012
• First Posted: March 2, 2012
• Study Start: March 1, 2012
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: November 19, 2025

Record last verified: 2015-03

Locations

FR (13)