Invasive CandidiasisNCT01047267
Pharmacokinetics of Anidulafungin on Intensive Care Unit (ICU)
An observational study of Invasive Candidiasis and Critically Ill, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
The objective of this study is to determine whether pharmacokinetic parameters of anidulafungin correlate with disease severity and plasma protein levels in critically ill patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Candidiasis, Critically Ill
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2010to Dec 2011
- 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: Adult patients with invasive candidiasis admitted to an intensive care unit.
Who may be able to join
- treatment with anidulafungin
- at least 18 years of age
- invasive candidiasis
- admitted to an intensive care unit
Who cannot join
- allergic to anidulafungin or its excipients
- contra-indication stated in SPC
- neutropenia
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Medical Center Groningen
Groningen, Provincie Groningen, 9713GZ
About this study
Official title: Pharmacokinetics of Anidulafungin in Critically Ill Patients With Invasive Candidiasis
The objective of this study is to determine whether pharmacokinetic parameters of anidulafungin correlate with disease severity and plasma protein levels in critically ill patients.
Read the detailed description
One of the risk factors for mortality of patients with candidemia is inadequate antifungal therapy. The first days in the intensive care unit (ICU), patients are unstable and it can be questioned whether therapeutic levels of anidulafungin are reached after a standard loading scheme. At this moment there are several clues that the PK of anidulafungin in critically ill patients is different, but an overall picture is lacking.
For the investigation of the correlation of the pharmacokinetics of anidulafungin and the disease severity a full pharmacokinetic profile will be obtained. Predictive scoring systems will be used to assess disease severity.
- Conditions
- Invasive Candidiasis, Critically Ill
- Keywords
- candidiasis, invasive fungal disease, critically ill, anidulafungin, pharmacokinetics
- Medical subject headings
- Candidiasis, Invasive, Critical Illness, Candidiasis, Invasive Fungal Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the correlation of pharmacokinetic parameters of anidulafungin with markers for disease severity - either disease severity scores or parameters (singly, or combined) for inflammation or organ function - and plasma protein levels.
Measured: 3 days
Secondary outcomes (5)
Time (in days) to culture conversion
Measured: max 28 days
Response to treatment at day 28
Measured: 28 days
Mortality at day 28 due to fungal infection and overall mortality at 28 days
Measured: 28 days
AUC/MIC ratio, time above MIC
Measured: max 28 days
Composing a pharmacokinetic model of anidulafungin in critically ill patients
Measured: max 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2010 (estimated)
- Study startJun 2010
- Primary completionNov 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 University Medical Center GroningenThe 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 only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JWC Alffenaar, University Medical Center Groningen
- Investigators
- JWC Alffenaar, PharmD, PhD, Study chair, University Medical Center GroningenMJP van Wanrooy, PharmD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01047267
- Sponsor's protocol ID
- ANIDULA-133
- Status last verified
- Apr 2012
- First submitted
- 11 Jan 2010
- Last updated
- 6 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
van Wanrooy MJ, Proost JH, Rodgers MG, Zijlstra JG, Uges DR, Kosterink JG, van der Werf TS, Alffenaar JW. Limited-sampling strategies for anidulafungin in critically ill patients. Antimicrob Agents Chemother. 2015 Feb;59(2):1177-81. doi: 10.1128/AAC.03375-14. Epub 2014 Dec 8.
PubMed 25487797van Wanrooy MJ, Rodgers MG, Uges DR, Arends JP, Zijlstra JG, van der Werf TS, Kosterink JG, Alffenaar JW. Low but sufficient anidulafungin exposure in critically ill patients. Antimicrob Agents Chemother. 2014;58(1):304-8. doi: 10.1128/AAC.01607-13. Epub 2013 Oct 28.
PubMed 24165173
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Anidulafungin in Critically Ill Patients With Invasive Candidiasis
- ClinicalTrials.gov ID
- NCT01047267
- Acronym / sponsor ID
- ANIDULA-133
- Conditions
- Invasive Candidiasis, Critically Ill
- Keywords
- candidiasis, invasive fungal disease, critically ill, anidulafungin, pharmacokinetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 12 Jan 2010 (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 objective of this study is to determine whether pharmacokinetic parameters of anidulafungin correlate with disease severity and plasma protein levels in critically ill patients.
Detailed description
One of the risk factors for mortality of patients with candidemia is inadequate antifungal therapy. The first days in the intensive care unit (ICU), patients are unstable and it can be questioned whether therapeutic levels of anidulafungin are reached after a standard loading scheme. At this moment there are several clues that the PK of anidulafungin in critically ill patients is different, but an overall picture is lacking.
For the investigation of the correlation of the pharmacokinetics of anidulafungin and the disease severity a full pharmacokinetic profile will be obtained. Predictive scoring systems will be used to assess disease severity.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with invasive candidiasis admitted to an intensive care unit.
Key inclusion criteria (4 listed)
- treatment with anidulafungin
- at least 18 years of age
- invasive candidiasis
- admitted to an intensive care unit
Key exclusion criteria (3 listed)
- allergic to anidulafungin or its excipients
- contra-indication stated in SPC
- neutropenia
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
To investigate the correlation of pharmacokinetic parameters of anidulafungin with markers for disease severity - either disease severity scores or parameters (singly, or combined) for inflammation or organ function - and plasma protein levels.
Time frame: 3 days
5 secondary outcomes
Time (in days) to culture conversion
Time frame: max 28 days
Response to treatment at day 28
Time frame: 28 days
Mortality at day 28 due to fungal infection and overall mortality at 28 days
Time frame: 28 days
AUC/MIC ratio, time above MIC
Time frame: max 28 days
Composing a pharmacokinetic model of anidulafungin in critically ill patients
Time frame: max 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2012.
- Derived from this study: PubMed 25487797van Wanrooy MJ, Proost JH, Rodgers MG, Zijlstra JG, Uges DR, Kosterink JG, van der Werf TS, Alffenaar JW. Limited-sampling strategies for anidulafungin in critically ill patients. Antimicrob Agents Chemother. 2015 Feb;59(2):1177-81. doi: 10.1128/AAC.03375-14. Epub 2014 Dec 8.
- Derived from this study: PubMed 24165173van Wanrooy MJ, Rodgers MG, Uges DR, Arends JP, Zijlstra JG, van der Werf TS, Kosterink JG, Alffenaar JW. Low but sufficient anidulafungin exposure in critically ill patients. Antimicrob Agents Chemother. 2014;58(1):304-8. doi: 10.1128/AAC.01607-13. Epub 2013 Oct 28.
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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.
JWC Alffenaar, PharmD, PhD study chair
University Medical Center Groningen
MJP van Wanrooy, PharmD principal investigator
University Medical Center Groningen
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 Invasive Candidiasis and Critically Ill, run by University Medical Center Groningen at 1 site 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 4 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: finished, as of the sponsor's last update on 6 Apr 2012. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the correlation of pharmacokinetic parameters of anidulafungin with markers for disease severity - either disease severity scores or parameters (singly, or combined) for inflammation or organ function - and plasma protein levels. (time frame: 3 days). 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 NCT01047267, which also lists 2 linked publications.
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 6 Apr 2012.