ClinicalTrials.gg
CompletedNCT03438981Updated Apr 28, 2021

Optimization of PK/PD Target Attainment for Ceftriaxone in Critically Ill Patients With Community-acquired Pneumonia.

An observational study in Pharmacokinetics and Critical Illness, sponsored by Universitaire Ziekenhuizen KU Leuven. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-28.

Primary conditionHypoalbuminemiaRegistry: Critical IllnessReclassifiedWhy we changed it
Registry
Critical Illness — the first condition term the registry derived for this study.
ClinicalTrials.gg
Hypoalbuminemia
Why
  1. Critical Illness is a broad heading, used only when no more specific condition is named.
  2. The study's title name Hypoalbuminemia.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Universitaire Ziekenhuizen KU Leuven · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study summary

WP2.1. PK/PD target attainment Plasma exposure ELF exposure WP2.2. Predictive dosing algorithm WP2.3. ECMO subset

Read the detailed description

First, the investigators will document exposure to ceftriaxone in plasma and epithelial lining fluid.

Second, the investigators will try to identify risk factors for not attaining PK/PD target. Based on significant predictors for target non attainment a predictive dosing algorithm will be constructed.

Finally in a small subset of ECMO patients PK exposure will be explored.

02

Conditions studied

  • Pharmacokinetics
  • Critical Illness

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Keywords

  • Pharmacokinetics
  • Ceftriaxone
  • critical illness
  • capillary leak
  • hypoalbuminemia
03

In context

Hypoalbuminemia Reclassified

41 studies on the registry are indexed under Hypoalbuminemia; 9 are open to participants now.

This study's enrollment of 30 is below the median of 160 across 15 observational studies indexed under Hypoalbuminemia.

Browse Hypoalbuminemia studies →

Lead sponsor

Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 963 studies on the registry; 267 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Compared within Hypoalbuminemia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Critical Illness. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Critically ill patients receiving ceftriaxone treatment for pneumonia.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Pneumonia
  • Admitted to an ICU ward
  • Treated with ceftriaxone

Exclusion criteria

Exclusion Criteria:

  • Pregnancy
  • DNR code 2-3
  • Renal replacement therapy
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. Risk factors for target non attainment

    risk factors will be assessed by comparing patients who attain target vs. those who don't

    Time frame: on day of sampling

07

Study locations

1 site
  • UZLeuven
    Leuven, 3000, Belgium
08

References and documents

Individual participant data

Plan to share: Undecided — To be discussed

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2013 to primary completion in Feb 2018, 61 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 13, 2018
First posted
Feb 20, 2018
StartActual
Jan 2013
Primary completionActual
Feb 2018
CompletionActual
Jul 2019
Last update
Apr 28, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03438981
Collaborators
KU Leuven
Responsible party
Matthias Gijsen (PharmD, Universitaire Ziekenhuizen KU Leuven) — Principal investigator
First posted
Feb 20, 2018
Start date
Jan 2013
Primary completion
Feb 2018
Completion
Jul 2019
Last update
Apr 28, 2021

Study contacts

Isabel Spriet, PhD PharmD
study director · isabel.spriet@uzleuven.be

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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