PharmacokineticsNCT03529617
Pharmacokinetics of Liposomal Amphotericin B in Critically Ill vs. Non-critically Ill Hematological Patients: Exploration of Covariates
An observational study of Pharmacokinetics and Liposomal Amphotericin B, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pharmacokinetics, Liposomal Amphotericin B, Critically Ill Patients
- What is being tested?
- Sample collection
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 19 Oct 2016to 31 Dec 2025
- How long will I take part?
- 1 Month
- 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: 1. critically ill patients treated with L-AmB 2. hematology patients treated with L-AmB
Who may be able to join
- Treatment with L-AmB
- Admitted to an ICU or Hematology ward
Who cannot join
- DNR 2 or 3
- Pregnant or lactating women
- Previous documentation of intolerance/sensitivity to L-AmB
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven, 3000
Ruth Van Daele, PharmD, +3216343264, ruth.vandaele@uzleuven.be
About this study
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.
Read the 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.
- Being tested
- Sample collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sample collectionOther
Plasma, urine, BAL and ascitic fluid sample collection.
| Study group | Role | What they receive |
|---|---|---|
| Critically ill patients | Patients admitted on ICU. Receives: Other: Sample collection | |
| Hematology patients | Patients admitted on the hematology ward. Receives: Other: Sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma exposure and PK parameters
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.
Measured: July 2020
Secondary outcomes (1)
Covariates
To document correlating covariates and to stimulate the pharmacokinetics of L-AmB to provide a rationale for optimal dosing strategy in critically ill patients.
Measured: July 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study start19 Oct 2016
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven
- Responsible party
- Sponsor
- Investigators
- Isabel Spriet, PharmD, PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03529617
- Sponsor's protocol ID
- S59273
- Status last verified
- Jul 2024
- First submitted
- 7 May 2018
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Liposomal Amphotericin B in Critically Ill vs. Non-critically Ill Hematological Patients: Exploration of Covariates
- ClinicalTrials.gov ID
- NCT03529617
- Acronym / sponsor ID
- S59273
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- KU Leuven
- Study start
- 19 Oct 2016 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 May 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.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Critically ill patients | – | Other: Sample collectionPatients admitted on ICU. |
| Hematology patients | – | Other: Sample collectionPatients admitted on the hematology ward. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. critically ill patients treated with L-AmB 2. hematology patients treated with L-AmB
Key inclusion criteria (2 listed)
- Treatment with L-AmB
- Admitted to an ICU or Hematology ward
Key exclusion criteria (3 listed)
- DNR 2 or 3
- Pregnant or lactating women
- Previous documentation of intolerance/sensitivity to L-AmB
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sample collectionPlasma, urine, BAL and ascitic fluid sample collection. | Other | Critically ill patients, Hematology patients |
Primary outcome
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.
1 secondary outcome
Covariates
Time frame: July 2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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, PharmD, PhD principal investigator
UZ Leuven
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 Liposomal Amphotericin B, 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 2 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: status not confirmed, as of the sponsor's last update on 3 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruth Van Daele, PharmD (+3216343264, ruth.vandaele@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma exposure and PK parameters (time frame: July 2020). 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 3 Jul 2024.