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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-A01339-32 | Other Identifier | ANSM |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Jean Yves Lefrant, MD PhD | Centre Hospitalier Universitaire de Nīmes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH du Pays d'Aix | Aix-en-Provence | 13616 | France | |||
| CHU d'Amiens - Hôpital Nord |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24429437 | Result | 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. |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| 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) |
| Amiens |
| 80054 |
| France |
| CHU d'Angers - Hôtel-Dieu | Angers | 49933 | France |
| CHU de Clermont Ferrand - Hôpital Estaing | Clermont-Ferrand | 63003 | France |
| CHU de Grenoble - Hôpital A Michallon | Grenoble | 38043 | France |
| APHM - Hôpital Nord | Marseille | 13915 | France |
| CHU de Montpellier - Hôpital Saint-Eloi | Montpellier | 34295 | France |
| CHU de Nice - Hôpital St-Roch | Nice | 06006 | France |
| CHU de Nîmes - Hôpital Universitaire Carémeau | Nîmes | 30029 | France |
| APHP - Hôpital Bichat - Claude Bernard | Paris | 75877 | France |
| CHU de Bordeaux - Hôpital Haut-Lévêque | Pessac | 33604 | France |
| CHU de Rennes - Hôpital PontChaillou | Rennes | 35033 | France |
| CHRU de Strasbourg - Hôpital Civil | Strasbourg | 67091 | France |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |