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NCT03438981 Clinical Trial

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

Critical Illness Clinical Trial

Official title:
Impact op Capillary Leak and Hypoalbuminemia on PK/PD of Ceftriaxone in Critically Ill Patients With Overwhelming Pneumonia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03438981
Other study ID # ML8457
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2013
Est. completion date July 2019

Study information
Verified date April 2021
Source Universitaire Ziekenhuizen Leuven
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date July 2019
Est. primary completion date February 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Pneumonia - Admitted to an ICU ward - Treated with ceftriaxone Exclusion Criteria: - Pregnancy - DNR code 2-3 - Renal replacement therapy

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Belgium UZLeuven Leuven

Sponsors (2)
Lead Sponsor Collaborator
Universitaire Ziekenhuizen Leuven KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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