NCT03438981

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 20, 2018

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

5.1 years

First QC Date

February 13, 2018

Last Update Submit

April 27, 2021

Conditions

PharmacokineticsCritical Illness

Keywords

PharmacokineticsCeftriaxonecritical illnesscapillary leakhypoalbuminemia

Outcome Measures

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

    on day of sampling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Critically ill patients receiving ceftriaxone treatment for pneumonia.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZLeuven

Leuven, 3000, Belgium

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma Serum Urine Broncho-alveolar lavage fluid

MeSH Terms

Conditions

Critical IllnessHypoalbuminemia

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHypoproteinemiaBlood Protein DisordersHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Isabel Spriet, PhD PharmD

    isabel.spriet@uzleuven.be

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PharmD

Study Record Dates

First Submitted

February 13, 2018

First Posted

February 20, 2018

Study Start

January 1, 2013

Primary Completion

February 1, 2018

Study Completion

July 1, 2019

Last Updated

April 28, 2021

Record last verified: 2021-04

Locations

BE(1)