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Completed

NCT Number: NCT01543334

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.

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Key information

Conditions

Administration of Antibiotics in Intensive Care Units

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CH du Pays d'Aix, Aix-en-Provence, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. [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).

  2. [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).

Secondary outcomes

  1. Apache II score

    Time frame: at time of blood sampling (day 1)

  2. SOFA score

    Time frame: at time of blood sampling (day 1)

  3. PIRO score

    Time frame: at time of blood sampling (day 1)

  4. Diagnosis at admission

    Time frame: Admission to ICU (day 1)

  5. Indication for antibiotic treatment

    Time frame: at time of blood sampling (day 1)

  6. did the patient have a surgical procedure in the last 24 hours?

    Time frame: at time of blood sampling (day 1)

    yes/no

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: DALI

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 2, 2012
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.