Antibiotic Concentrations Among Critically Ill Patients

NCT ID: NCT01543334

Last Updated: 2025-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

98 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-04-01

Brief Summary

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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.

Detailed Description

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Conditions

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Administration of Antibiotics in Intensive Care Units

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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).

Blood sampling

Intervention Type 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.

Interventions

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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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean Yves Lefrant, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

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CH du Pays d'Aix

Aix-en-Provence, , France

Site Status

CHU d'Amiens - Hôpital Nord

Amiens, , France

Site Status

CHU d'Angers - Hôtel-Dieu

Angers, , France

Site Status

CHU de Clermont Ferrand - Hôpital Estaing

Clermont-Ferrand, , France

Site Status

CHU de Grenoble - Hôpital A Michallon

Grenoble, , France

Site Status

APHM - Hôpital Nord

Marseille, , France

Site Status

CHU de Montpellier - Hôpital Saint-Eloi

Montpellier, , France

Site Status

CHU de Nice - Hôpital St-Roch

Nice, , France

Site Status

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

Site Status

APHP - Hôpital Bichat - Claude Bernard

Paris, , France

Site Status

CHU de Bordeaux - Hôpital Haut-Lévêque

Pessac, , France

Site Status

CHU de Rennes - Hôpital PontChaillou

Rennes, , France

Site Status

CHRU de Strasbourg - Hôpital Civil

Strasbourg, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 24429437 (View on PubMed)

Other Identifiers

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2011-A01339-32

Identifier Type: OTHER

Identifier Source: secondary_id

LOCAL/2011/JYL-03

Identifier Type: -

Identifier Source: org_study_id

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