Invasive CandidiasisANICKNCT01438216
Anidulafungin Pharmacokinetics in Intensive Care Unit Patients
An observational study of Invasive Candidiasis and Candidemia, run by Amsterdam UMC, location VUmc at 2 sites in Netherlands.
Trial summary
The purpose of this study is to determine the pharmacokinetics of anidulafungin in intensive care patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Candidiasis, Candidemia
- How many people
- 20 participants
- Where
- 2 sitesNetherlands
- Study dates
- Sep 2011to Mar 2012
- 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: Intensive Care patients
Who may be able to join
- Patient is admitted to the intensive care unit
- Patient has a central (venous) infusion line
- Patient is at least 18 years old
- Patient receives treatment with anidulafungin
- that is initiated on the ICU or
- that is continued on the ICU and the patient has had no more than 2 days of treatment with anidulafungin
Who cannot join
- Documented history of sensitivity to medicinal products or excipients similar to those found in the anidulafungin preparation
- Patient receives treatment with anidulafungin that is continued on the ICU and the patient has had 3 or more days of treatment with anidulafungin
- A woman that is pregnant, wanting to become pregnant or nursing an infant
- < 48 hours (expected) treatment with anidulafungin on the ICU ward
- Has previously participated in this trial.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites, 2 recruiting
- Recruiting
VU University Medical Center
Amsterdam, North Holland, 1081 HV
Vera M Middel-Baars, PharmD, +31 20 4445282, v.middel-baars@vumc.nl
Eleonora L Swart, PhD, +31 20 4443524, el.swart@vumc.nl
- Recruiting
Radboud University Nijmegen Medical Center
Nijmegen, Gelderland, 6525 GA
Roger Brüggeman, PharmD, +31 243616405, r.bruggemann@akf.umcn.nl
Roger Brüggemann, PharmD
About this study
Official title: Anidulafungin Population Kinetics in the Intensive Care Population
The purpose of this study is to determine the pharmacokinetics of anidulafungin in intensive care patients.
Read the detailed description
Not a lot is known about the pharmacokinetic profile of anidulafungin in IC-patients. IC-patients are at high(er) risk for getting a systemic mould/yeast infection. Anidulafungin is a safe echinocandin with, so far, no reported interactions and few adverse effects. Due to this, anidulafungin is used more often on IC-wards. It is part of the national (Netherlands) IC sepsis protocol. The factors that influence the pharmacokinetics of anidulafungin in IC-patients has not been studied yet. Because these factors are unknown for this population, it is necessary for this research to be done.
Any patient with an (suspected) invasive candidiasis whom is treated with anidulafunging can be includen.
20 patients will be included from 2 different university hospital (10 each). Samples will be taken on different days and timepoints, troughlevels on all treatment days and on treatment day 3 and 7 more samples will be taken voor AUC calculations.
- Conditions
- Invasive Candidiasis, Candidemia
- Keywords
- Pharmacokinetics, Intensive Care, Candidemia, Invasive candidiasis, Anidulafungin
- Medical subject headings
- Candidiasis, Invasive, Candidemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| VUmc IC | Due to multicentre, 2 groups of patient in 1 cohort | |
| UMCN IC | Due to multicentre, 2 groups of patient in 1 cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic population model for anidulafungin for the ICU population
The populationmodel will be created with NONMEM. The concentrations in the bloodsamples will be the input source for this model.
Measured: 1 year, after inclusion of 20 patients
Secondary outcomes (5)
Time until clinical and microbiological response is reached
Registration of time till response
Measured: 1 year, after inclusion of 20 patients
To determine the covariates that influence the kinetics of anidulafungin.
With the help from modeling program NONMEM
Measured: 1 year, after inclusion of 20 patients
To determine the optimal dosage(scheme) for intensive care patients.
Calculation of optimal dosage can be done by NONMEM.
Measured: 1 year, after inclusion of 20 patients
To determine which of the two ratios is the most predictive voor clinical outcome: AUC/MIC or Cmax/MIC.
If the actual MIC is known, this can can be determined.
Measured: 1 year, after inclusion of 20 patients
Registration of side effects and adverse events
To register safety od anidulafungin use on ICU
Measured: 1 year, after inclusion of 20 patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionFeb 2012 (estimated)
- Study completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Invasive CandidiasisStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- Radboud University Medical Center
- Responsible party
- Principal investigator, V.M. Middel-Baars, Amsterdam UMC, location VUmc
- Investigators
- Vera M Middel-Baars, PharmD, Principal investigator, Amsterdam UMC, location VUmcEleonora L Swart, PhD, Principal investigator, Amsterdam UMC, location VUmcRoger Brüggemann, PharmD, Principal investigator, Radboud University Nijmegen Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01438216
- Sponsor's protocol ID
- ANIPKIC001
- Other IDs
- 2011-001911-30
- Acronym
- ANICK
- Status last verified
- Sep 2011
- First submitted
- 14 Sep 2011
- Last updated
- 22 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Bruggemann RJ, Middel-Baars V, de Lange DW, Colbers A, Girbes AR, Pickkers P, Swart EL. Pharmacokinetics of Anidulafungin in Critically Ill Intensive Care Unit Patients with Suspected or Proven Invasive Fungal Infections. Antimicrob Agents Chemother. 2017 Jan 24;61(2):e01894-16. doi: 10.1128/AAC.01894-16. Print 2017 Feb.
PubMed 27872072
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anidulafungin Population Kinetics in the Intensive Care Population
- ClinicalTrials.gov ID
- NCT01438216
- Acronym / sponsor ID
- ANICK / ANIPKIC001
- Conditions
- Invasive Candidiasis, Candidemia
- Keywords
- Pharmacokinetics, Intensive Care, Candidemia, Invasive candidiasis, Anidulafungin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- Radboud University Medical Center
- Study start
- Sep 2011
- Primary completion
- Feb 2012 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 22 Sep 2011 (estimated)
- 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.
The purpose of this study is to determine the pharmacokinetics of anidulafungin in intensive care patients.
Detailed description
Not a lot is known about the pharmacokinetic profile of anidulafungin in IC-patients. IC-patients are at high(er) risk for getting a systemic mould/yeast infection. Anidulafungin is a safe echinocandin with, so far, no reported interactions and few adverse effects. Due to this, anidulafungin is used more often on IC-wards. It is part of the national (Netherlands) IC sepsis protocol. The factors that influence the pharmacokinetics of anidulafungin in IC-patients has not been studied yet. Because these factors are unknown for this population, it is necessary for this research to be done.
Any patient with an (suspected) invasive candidiasis whom is treated with anidulafunging can be includen.
20 patients will be included from 2 different university hospital (10 each). Samples will be taken on different days and timepoints, troughlevels on all treatment days and on treatment day 3 and 7 more samples will be taken voor AUC calculations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VUmc IC | – | –Due to multicentre, 2 groups of patient in 1 cohort |
| UMCN IC | – | –Due to multicentre, 2 groups of patient in 1 cohort |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Intensive Care patients
Key inclusion criteria (6 listed)
- Patient is admitted to the intensive care unit
- Patient has a central (venous) infusion line
- Patient is at least 18 years old
- Patient receives treatment with anidulafungin
Key exclusion criteria (5 listed)
- Documented history of sensitivity to medicinal products or excipients similar to those found in the anidulafungin preparation
- Patient receives treatment with anidulafungin that is continued on the ICU and the patient has had 3 or more days of treatment with anidulafungin
- A woman that is pregnant, wanting to become pregnant or nursing an infant
- < 48 hours (expected) treatment with anidulafungin on the ICU ward
- Has previously participated in this trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pharmacokinetic population model for anidulafungin for the ICU population
Time frame: 1 year, after inclusion of 20 patients
The populationmodel will be created with NONMEM. The concentrations in the bloodsamples will be the input source for this model.
5 secondary outcomes
Time until clinical and microbiological response is reached
Time frame: 1 year, after inclusion of 20 patients
To determine the covariates that influence the kinetics of anidulafungin.
Time frame: 1 year, after inclusion of 20 patients
To determine the optimal dosage(scheme) for intensive care patients.
Time frame: 1 year, after inclusion of 20 patients
To determine which of the two ratios is the most predictive voor clinical outcome: AUC/MIC or Cmax/MIC.
Time frame: 1 year, after inclusion of 20 patients
Registration of side effects and adverse events
Time frame: 1 year, after inclusion of 20 patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2011.
- Derived from this study: PubMed 27872072Bruggemann RJ, Middel-Baars V, de Lange DW, Colbers A, Girbes AR, Pickkers P, Swart EL. Pharmacokinetics of Anidulafungin in Critically Ill Intensive Care Unit Patients with Suspected or Proven Invasive Fungal Infections. Antimicrob Agents Chemother. 2017 Jan 24;61(2):e01894-16. doi: 10.1128/AAC.01894-16. Print 2017 Feb.
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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.
Vera M Middel-Baars, PharmD principal investigator
Amsterdam UMC, location VUmc
Eleonora L Swart, PhD principal investigator
Amsterdam UMC, location VUmc
Roger Brüggemann, PharmD principal investigator
Radboud University Nijmegen Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Candidiasis and Candidemia, run by Amsterdam UMC, location VUmc at 2 sites in Netherlands.
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 6 inclusion and 5 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 22 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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 Vera M Middel-Baars, PharmD (+31 20 4445282, v.middel-baars@vumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic population model for anidulafungin for the ICU population (time frame: 1 year, after inclusion of 20 patients). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01438216, which also lists 1 linked publication.
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 22 Sep 2011.