Pharmacokinetics of Liposomal Amphotericin B in Critically Ill vs. Non-critically Ill Hematological Patients: Exploration of Covariates
NCT ID: NCT03529617
Last Updated: 2024-07-03
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.
RECRUITING
60 participants
OBSERVATIONAL
2016-10-19
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study to Evaluate the Effect of Multiple-Dose Ritlecitinib on the Pharmacokinetics (PK) of Tolbutamide
NCT05097716
A Study To Investigate The Pharmacokinetics, Safety And Tolerability Of An Intravenous And Oral Form Of A Compound In Subjects With Varying Degrees Of Renal Impairment And Normal Renal Function
NCT00759564
Study Evaluating the Pharmacokinetics of the Potential Drug Interaction Between CYP2C9 Inhibitor and Substrate
NCT00369304
Pharmacokinetics (PK) Study of Gepotidacin (GSK2140944) in Adult Subjects With Varying Degrees of Hepatic Impairment and in Matched Control Subjects With Normal Hepatic Function
NCT03562117
Target Site Pharmacokinetics of Doripenem at Steady State in Intubated Intensive Care Patients
NCT01414959
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The pharmacokinetic exposure to liposomal amphotericin B in plasma, urine, BAL and ascitic fluid will be compared between the two population groups in an early and late exposure day.
Correlating covariates will be identified to provide a rationale for optimal dosing strategy in critically ill patients.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Critically ill patients
Patients admitted on ICU.
Sample collection
Plasma, urine, BAL and ascitic fluid sample collection.
Hematology patients
Patients admitted on the hematology ward.
Sample collection
Plasma, urine, BAL and ascitic fluid sample collection.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sample collection
Plasma, urine, BAL and ascitic fluid sample collection.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Admitted to an ICU or Hematology ward
Exclusion Criteria
* Pregnant or lactating women
* Previous documentation of intolerance/sensitivity to L-AmB
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
KU Leuven
OTHER
Universitaire Ziekenhuizen KU Leuven
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.
Isabel Spriet, PharmD, PhD
Role: PRINCIPAL_INVESTIGATOR
UZ Leuven
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UZ Leuven
Leuven, , Belgium
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
S59273
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.