DALI: Antibiotic Concentrations Among Critically Ill Patients

Sponsor

Centre Hospitalier Universitaire de Nīmes (Other)

Overall Status

Completed

CT.gov ID

NCT01543334

Collaborator

(none)

Enrollment

Locations

7.5

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Administration of Antibiotics in Intensive Care Units	Biological: Blood sampling

Study Design

Study Type:

Observational

Actual Enrollment :

98 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

Antibiotic Concentrations Among Critically Ill Patients

Study Start Date :

Mar 1, 2012

Actual Primary Completion Date :

Mar 1, 2012

Actual Study Completion Date :

Mar 1, 2012

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	CH du Pays d'Aix	Aix en Provence	France	13616
2	CHU d'Amiens - Hôpital Nord	Amiens Cedex 1	France	80054
3	CHU d'Angers - Hôtel-Dieu	Angers	France	49933
4	CHU de Clermont Ferrand - Hôpital Estaing	Clermont Ferrand	France	63003
5	CHU de Grenoble - Hôpital A Michallon	Grenoble	France	38043
6	APHM - Hôpital Nord	Marseille Cedex 20	France	13915
7	CHU de Montpellier - Hôpital Saint-Eloi	Montpellier	France	34295
8	CHU de Nice - Hôpital St-Roch	Nice	France	06006
9	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 9	France	30029
10	APHP - Hôpital Bichat - Claude Bernard	Paris Cedex 18	France	75877
11	CHU de Bordeaux - Hôpital Haut-Lévêque	Pessac Cedex	France	33604
12	CHU de Rennes - Hôpital PontChaillou	Rennes	France	35033
13	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Nīmes

ClinicalTrials.gov Identifier:

NCT01543334

Other Study ID Numbers:

LOCAL/2011/JYL-03
2011-A01339-32

First Posted:

Mar 2, 2012

Last Update Posted:

Mar 26, 2015

Last Verified:

Mar 1, 2015

Keywords provided by Centre Hospitalier Universitaire de Nīmes

intensive care

antibiotic levels in blood samples

Additional relevant MeSH terms:

Critical Illness

Study Results

No Results Posted as of Mar 26, 2015