- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03438981
Optimization of PK/PD Target Attainment for Ceftriaxone in Critically Ill Patients With Community-acquired Pneumonia.
April 27, 2021 updated by: Matthias Gijsen, Universitaire Ziekenhuizen KU Leuven
Impact op Capillary Leak and Hypoalbuminemia on PK/PD of Ceftriaxone in Critically Ill Patients With Overwhelming Pneumonia
WP2.1.
PK/PD target attainment Plasma exposure ELF exposure WP2.2.
Predictive dosing algorithm WP2.3.
ECMO subset
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Leuven, Belgium, 3000
- UZLeuven
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Critically ill patients receiving ceftriaxone treatment for pneumonia.
Description
Inclusion Criteria:
- Pneumonia
- Admitted to an ICU ward
- Treated with ceftriaxone
Exclusion Criteria:
- Pregnancy
- DNR code 2-3
- Renal replacement therapy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Risk factors for target non attainment
Time Frame: on day of sampling
|
risk factors will be assessed by comparing patients who attain target vs. those who don't
|
on day of sampling
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Isabel Spriet, PhD PharmD, isabel.spriet@uzleuven.be
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2013
Primary Completion (Actual)
February 1, 2018
Study Completion (Actual)
July 1, 2019
Study Registration Dates
First Submitted
February 13, 2018
First Submitted That Met QC Criteria
February 13, 2018
First Posted (Actual)
February 20, 2018
Study Record Updates
Last Update Posted (Actual)
April 28, 2021
Last Update Submitted That Met QC Criteria
April 27, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ML8457
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
To be discussed
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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