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Pharmacokinetics of Liposomal Amphotericin B in Critically Ill vs. Non-critically Ill Hematological Patients: Exploration of Covariates

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ClinicalTrials.gov Identifier: NCT03529617
Recruitment Status : Recruiting
First Posted : May 18, 2018
Last Update Posted : May 18, 2018
Sponsor:
Collaborator:
KU Leuven
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Brief Summary:
This prospective study will compare the pharmacokinetic exposure to liposomal amphotericin B between critically ill patients and non-critically ill (hematology) patients in an early and late exposure day.

Condition or disease Intervention/treatment
Pharmacokinetics Liposomal Amphotericin B Critically Ill Patients Other: Sample collection

Detailed Description:

This phase IV, open label, non-randomized, monocenter pharmacokinetic study will be carried out in critically ill and non-critically ill (hematology) patients receiving multiple dose treatment with L-AmB.

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Official Title: Pharmacokinetics of Liposomal Amphotericin B in Critically Ill vs. Non-critically Ill Hematological Patients: Exploration of Covariates
Actual Study Start Date : October 19, 2016
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : December 31, 2020

Group/Cohort Intervention/treatment
Critically ill patients
Patients admitted on ICU.
Other: Sample collection
Plasma, urine, BAL and ascitic fluid sample collection.

Hematology patients
Patients admitted on the hematology ward.
Other: Sample collection
Plasma, urine, BAL and ascitic fluid sample collection.




Primary Outcome Measures :
  1. Plasma exposure and PK parameters [ Time Frame: July 2020 ]
    To document and compare plasma exposure and PK parameters in an ICU vs. non ICU hematology patient cohort in the early and late phase of L-AmB treatment.


Secondary Outcome Measures :
  1. Covariates [ Time Frame: July 2020 ]
    To document correlating covariates and to stimulate the pharmacokinetics of L-AmB to provide a rationale for optimal dosing strategy in critically ill patients.


Biospecimen Retention:   Samples Without DNA
Blood (plasma) Urine BAL (bronchoalveolar lavage) Ascitic fluid


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
  1. critically ill patients treated with L-AmB
  2. hematology patients treated with L-AmB
Criteria

Inclusion Criteria:

  • Treatment with L-AmB
  • Admitted to an ICU or Hematology ward

Exclusion Criteria:

  • DNR 2 or 3
  • Pregnant or lactating women
  • Previous documentation of intolerance/sensitivity to L-AmB

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03529617


Contacts
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Contact: Ruth Van Daele, PharmD +3216343264 ruth.vandaele@uzleuven.be
Contact: Isabel Spriet, PharmD, PhD +3216341261 isabel.spriet@uzleuven.be

Locations
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Belgium
UZ Leuven Recruiting
Leuven, Belgium, 3000
Contact: Ruth Van Daele, PharmD    +3216343264    ruth.vandaele@uzleuven.be   
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
KU Leuven
Investigators
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Principal Investigator: Isabel Spriet, PharmD, PhD UZ Leuven
Additional Information:

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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT03529617    
Other Study ID Numbers: S59273
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes