Administration of Antibiotics in Intensive Care Units Clinical Trial
— DALIOfficial title:
Antibiotic Concentrations Among Critically Ill Patients
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.
| Status | Completed |
| Enrollment | 98 |
| Est. completion date | March 2012 |
| Est. primary completion date | March 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Observational Model: Case-Only, Time Perspective: Cross-Sectional
| Country | Name | City | State |
|---|---|---|---|
| France | CH du Pays d'Aix | Aix en Provence | |
| France | CHU d'Amiens - Hôpital Nord | Amiens Cedex 1 | |
| France | CHU d'Angers - Hôtel-Dieu | Angers | |
| France | CHU de Clermont Ferrand - Hôpital Estaing | Clermont Ferrand | |
| France | CHU de Grenoble - Hôpital A Michallon | Grenoble | |
| France | APHM - Hôpital Nord | Marseille Cedex 20 | |
| France | CHU de Montpellier - Hôpital Saint-Eloi | Montpellier | |
| France | CHU de Nice - Hôpital St-Roch | Nice | |
| France | CHU de Nîmes - Hôpital Universitaire Carémeau | Nîmes Cedex 9 | |
| France | APHP - Hôpital Bichat - Claude Bernard | Paris Cedex 18 | |
| France | CHU de Bordeaux - Hôpital Haut-Lévêque | Pessac Cedex | |
| France | CHU de Rennes - Hôpital PontChaillou | Rennes | |
| France | CHRU de Strasbourg - Hôpital Civil | Strasbourg Cedex |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Universitaire de Nimes |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | [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) | No |
| Primary | [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) | No |
| Secondary | Apache II score | at time of blood sampling (day 1) | No | |
| Secondary | SOFA score | at time of blood sampling (day 1) | No | |
| Secondary | PIRO score | at time of blood sampling (day 1) | No | |
| Secondary | Diagnosis at admission | Admission to ICU (day 1) | No | |
| Secondary | Indication for antibiotic treatment | at time of blood sampling (day 1) | No | |
| Secondary | did the patient have a surgical procedure in the last 24 hours? | yes/no | at time of blood sampling (day 1) | No |