PharmacokineticsNCT03438981
Optimization of PK/PD Target Attainment for Ceftriaxone in Critically Ill Patients With Community-acquired Pneumonia.
An observational study of Pharmacokinetics and Critical Illness, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
WP2.1. PK/PD target attainment Plasma exposure ELF exposure WP2.2. Predictive dosing algorithm WP2.3. ECMO subset Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pharmacokinetics, Critical Illness
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2013to Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patients receiving ceftriaxone treatment for pneumonia.
Who may be able to join
- Pneumonia
- Admitted to an ICU ward
- Treated with ceftriaxone
Who cannot join
- Pregnancy
- DNR code 2-3
- Renal replacement therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Pharmacokinetics, Critical Illness
- Keywords
- Pharmacokinetics, Ceftriaxone, critical illness, capillary leak, hypoalbuminemia
- Medical subject headings
- Critical Illness, Hypoalbuminemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk factors for target non attainment
risk factors will be assessed by comparing patients who attain target vs. those who don't
Measured: on day of sampling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study startJan 2013
- Primary completionFeb 2018
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven
- Responsible party
- Principal investigator, Matthias Gijsen, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Isabel Spriet, PhD PharmD, Study director, isabel.spriet@uzleuven.be
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03438981
- Sponsor's protocol ID
- ML8457
- Status last verified
- Apr 2021
- First submitted
- 13 Feb 2018
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To be discussed
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact op Capillary Leak and Hypoalbuminemia on PK/PD of Ceftriaxone in Critically Ill Patients With Overwhelming Pneumonia
- ClinicalTrials.gov ID
- NCT03438981
- Acronym / sponsor ID
- ML8457
- Conditions
- Pharmacokinetics, Critical Illness
- Keywords
- Pharmacokinetics, Ceftriaxone, critical illness, capillary leak, hypoalbuminemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- KU Leuven
- Study start
- Jan 2013 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 20 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
WP2.1. PK/PD target attainment Plasma exposure ELF exposure WP2.2. Predictive dosing algorithm WP2.3. ECMO subset
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients receiving ceftriaxone treatment for pneumonia.
Key inclusion criteria (3 listed)
- Pneumonia
- Admitted to an ICU ward
- Treated with ceftriaxone
Key exclusion criteria (3 listed)
- Pregnancy
- DNR code 2-3
- Renal replacement therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Individual participant dataSharing planned: Undecided. To be discussed
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabel Spriet, PhD PharmD study director
isabel.spriet@uzleuven.be
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pharmacokinetics and Critical Illness, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk factors for target non attainment (time frame: on day of sampling). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.