Antibiotic Concentrations Among Critically Ill Patients (DALI)
This study has been completed.
Sponsor:
Centre Hospitalier Universitaire de Nīmes
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01543334
First received: February 20, 2012
Last updated: March 23, 2013
Last verified: March 2013
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Purpose
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 | Intervention |
|---|---|
|
Administration of Antibiotics in Intensive Care Units |
Biological: Blood sampling |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Cross-Sectional |
| Official Title: | Antibiotic Concentrations Among Critically Ill Patients |
Resource links provided by NLM:
Further study details as provided by Centre Hospitalier Universitaire de Nīmes:
Primary Outcome Measures:
- [antibiotics] in blood versus bactericidal activity [ Time Frame: 1/2 antibiotic dose interval (expected maximum of 4 days; days 1 to 4) ] [ Designated as safety issue: No ]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 [ Time Frame: 30 minutes before second antibiotic dose (expected maximum of 7 days; days 1 to 7) ] [ Designated as safety issue: No ]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 [ Time Frame: at time of blood sampling (day 1) ] [ Designated as safety issue: No ]
- SOFA score [ Time Frame: at time of blood sampling (day 1) ] [ Designated as safety issue: No ]
- PIRO score [ Time Frame: at time of blood sampling (day 1) ] [ Designated as safety issue: No ]
- Diagnosis at admission [ Time Frame: Admission to ICU (day 1) ] [ Designated as safety issue: No ]
- Indication for antibiotic treatment [ Time Frame: at time of blood sampling (day 1) ] [ Designated as safety issue: No ]
- did the patient have a surgical procedure in the last 24 hours? [ Time Frame: at time of blood sampling (day 1) ] [ Designated as safety issue: No ]yes/no
| Enrollment: | 98 |
| Study Start Date: | March 2012 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| 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.
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01543334
Locations
| France | |
| CH du Pays d'Aix | |
| Aix en Provence, France, 13616 | |
| CHU d'Amiens - Hôpital Nord | |
| Amiens Cedex 1, France, 80054 | |
| CHU d'Angers - Hôtel-Dieu | |
| Angers, France, 49933 | |
| CHU de Clermont Ferrand - Hôpital Estaing | |
| Clermont Ferrand, France, 63003 | |
| CHU de Grenoble - Hôpital A Michallon | |
| Grenoble, France, 38043 | |
| APHM - Hôpital Nord | |
| Marseille Cedex 20, France, 13915 | |
| CHU de Montpellier - Hôpital Saint-Eloi | |
| Montpellier, France, 34295 | |
| CHU de Nice - Hôpital St-Roch | |
| Nice, France, 06006 | |
| CHU de Nîmes - Hôpital Universitaire Carémeau | |
| Nîmes Cedex 9, France, 30029 | |
| APHP - Hôpital Bichat - Claude Bernard | |
| Paris Cedex 18, France, 75877 | |
| CHU de Bordeaux - Hôpital Haut-Lévêque | |
| Pessac Cedex, France, 33604 | |
| CHU de Rennes - Hôpital PontChaillou | |
| Rennes, France, 35033 | |
| 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 |
More Information
No publications provided
| Responsible Party: | Centre Hospitalier Universitaire de Nīmes |
| ClinicalTrials.gov Identifier: | NCT01543334 History of Changes |
| Other Study ID Numbers: | LOCAL/2011/JYL-03, 2011-A01339-32 |
| Study First Received: | February 20, 2012 |
| Last Updated: | March 23, 2013 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: Committee for the Protection of Personnes |
Keywords provided by Centre Hospitalier Universitaire de Nīmes:
|
intensive care antibiotic levels in blood samples |
Additional relevant MeSH terms:
|
Critical Illness Disease Attributes Pathologic Processes Anti-Bacterial Agents |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013