Administration of Antibiotics in Intensive Care UnitsDALINCT01543334
Antibiotic Concentrations Among Critically Ill Patients
An observational study of Administration of Antibiotics in Intensive Care Units, run by Centre Hospitalier Universitaire de Nīmes at 13 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Administration of Antibiotics in Intensive Care Units
- What is being tested?
- Blood sampling
- How many people
- 98 participants
- Where
- 13 sitesFrance
- Study dates
- Mar 2012to 1 Apr 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
France13 sites
CH du Pays d'Aix
Aix-en-Provence, 13616
CHU d'Amiens - Hôpital Nord
Amiens, 80054
CHU d'Angers - Hôtel-Dieu
Angers, 49933
CHU de Clermont Ferrand - Hôpital Estaing
Clermont-Ferrand, 63003
CHU de Grenoble - Hôpital A Michallon
Grenoble, 38043
APHM - Hôpital Nord
Marseille, 13915
CHU de Montpellier - Hôpital Saint-Eloi
Montpellier, 34295
CHU de Nice - Hôpital St-Roch
Nice, 06006
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029
APHP - Hôpital Bichat - Claude Bernard
Paris, 75877
CHU de Bordeaux - Hôpital Haut-Lévêque
Pessac, 33604
CHU de Rennes - Hôpital PontChaillou
Rennes, 35033
CHRU de Strasbourg - Hôpital Civil
Strasbourg, 67091
About this study
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.
- Being tested
- Blood sampling
- Keywords
- intensive care, antibiotic levels in blood samples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Biological: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
[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).
Measured: 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).
Measured: 30 minutes before second antibiotic dose (expected maximum of 7 days; days 1 to 7)
Secondary outcomes (6)
Apache II score
Measured: at time of blood sampling (day 1)
SOFA score
Measured: at time of blood sampling (day 1)
PIRO score
Measured: at time of blood sampling (day 1)
Diagnosis at admission
Measured: Admission to ICU (day 1)
Indication for antibiotic treatment
Measured: at time of blood sampling (day 1)
did the patient have a surgical procedure in the last 24 hours?
yes/no
Measured: at time of blood sampling (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2012 (estimated)
- Study startMar 2012
- Primary completion1 Apr 2012
- Study completion1 Apr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Administration of Antibiotics in Intensive Care UnitsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Yves Lefrant, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01543334
- Sponsor's protocol ID
- LOCAL/2011/JYL-03
- Other IDs
- 2011-A01339-32
- Acronym
- DALI
- Status last verified
- Mar 2015
- First submitted
- 20 Feb 2012
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24429437
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Concentrations Among Critically Ill Patients
- ClinicalTrials.gov ID
- NCT01543334
- Acronym / sponsor ID
- DALI / LOCAL/2011/JYL-03
- Keywords
- intensive care, antibiotic levels in blood samples
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- 1 Apr 2012 (actual)
- Study completion
- 1 Apr 2012 (actual)
- First posted
- 2 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Biological: Blood samplingPatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingBlood 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. | Biological | Patients |
Primary outcome
[antibiotics] in blood versus bactericidal activity
Time frame: 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
Time frame: 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).
6 secondary outcomes
Apache II score
Time frame: at time of blood sampling (day 1)
SOFA score
Time frame: at time of blood sampling (day 1)
PIRO score
Time frame: at time of blood sampling (day 1)
Diagnosis at admission
Time frame: Admission to ICU (day 1)
Indication for antibiotic treatment
Time frame: at time of blood sampling (day 1)
did the patient have a surgical procedure in the last 24 hours?
Time frame: at time of blood sampling (day 1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Results publication: PubMed 24429437Roberts 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.
Related trials for Administration of Antibiotics in Intensive Care Units
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EARLY Antibiotics aDAptation in Severe Pneumonia(The EARLY ADAPT Study)
VAP - Ventilator Associated Pneumonia, Antibiotic
RecruitingObservational study
Population Pharmacokinetics of Anti-infectives in Critically Ill Children
Pediatric Intensive Care Unit, Pediatric Immuno-hematology Department
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Yves Lefrant, MD PhD principal investigator
Centre Hospitalier Universitaire de Nīmes
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Administration of Antibiotics in Intensive Care Units, run by Centre Hospitalier Universitaire de Nīmes at 13 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
[antibiotics] in blood versus bactericidal activity (time frame: 1/2 antibiotic dose interval (expected maximum of 4 days; days 1 to 4)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01543334, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.