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Antibiotic Concentrations Among Critically Ill Patients

Antibiotic Concentrations Among Critically Ill Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01543334
Acronym
DALI
Enrollment
98
Registered
2012-03-02
Start date
2012-03-31
Completion date
2012-04-01
Last updated
2025-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Administration of Antibiotics in Intensive Care Units

Keywords

intensive care, antibiotic levels in blood samples

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.

Interventions

BIOLOGICALBlood 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.

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
[antibiotics] in blood versus bactericidal activity1/2 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).

Secondary

MeasureTime frameDescription
SOFA scoreat time of blood sampling (day 1)
PIRO scoreat time of blood sampling (day 1)
Apache II scoreat time of blood sampling (day 1)
Indication for antibiotic treatmentat 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
Diagnosis at admissionAdmission to ICU (day 1)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026