Pharmacokinetics of Caspofungin (Cancidas ®) Given Intravenously as Therapy to Patients With an Invasive Fungal Infection in the Intensive Care Unit - a Search for Co-variates
NCT ID: NCT01533558
Last Updated: 2020-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
20 participants
OBSERVATIONAL
2012-01-31
2013-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Full PK curves will be taken on day 3 and a limited PK curve on day 7, trough levels will be taken daily.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
To be able to include 20 patients within the study duration, a multi-centre approach is necessary.
Patients will receive standard care, as stated in the SPC or according to local protocols. Blood sampling for PK analysis will be retrieved through a central venous catheter. Approximately 60mL will be drawn in total for this study. Patients will be monitored daily during the treatment period for adverse events of the study drug.
Although steady state of caspofungin will be achieved after approximately 14 days of treatment, full PK curves will be taken on day 3. As probably not all patients included will be treated with caspofungin for 14 days, taking full PK curves on day 14 is considered not feasible. These two moments of PK analysis will enable the determination steady state and enable the determination of intra-individual variability.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
caspofungin
caspofungin dosing
caspofungin
normal dosage for caspofungin, not adapted for the study
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
caspofungin
normal dosage for caspofungin, not adapted for the study
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Subject is at least 18 and not older than 65 years of age on the day of the first dosing
* Subject has been treated with caspofungin for a maximum of two days before enrolment in this trial
* Is managed with a central venous catheter
Exclusion Criteria
* Documented history of sensitivity to medicinal products or excipients similar to those found in the caspofungin preparation
* Positive HIV test or hepatitis B or C test
* History of QT time prolongation
* History of or current abuse of drugs, alcohol or solvents
* Has previously participated in this trial
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Radboud University Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Roger Brüggemann, PhD, PharmD
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Rijnstate Hospital
Arnhem, , Netherlands
Canisius Wilhelmina Hospital (CWZ)
Nijmegen, , Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, , Netherlands
University Medical Centre Utrecht
Utrecht, , Netherlands
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Muilwijk EW, Schouten JA, van Leeuwen HJ, van Zanten AR, de Lange DW, Colbers A, Verweij PE, Burger DM, Pickkers P, Bruggemann RJ. Pharmacokinetics of caspofungin in ICU patients. J Antimicrob Chemother. 2014 Dec;69(12):3294-9. doi: 10.1093/jac/dku313. Epub 2014 Aug 19.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AKF UMCN 11.02
Identifier Type: -
Identifier Source: org_study_id