Critical IllnessNCT01716988
Pharmacokinetics of Micafungin in Critically Ill Patients
An observational study of Critical Illness and Invasive Candidiasis, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
A study of micafungin in ICU versus non-ICU patients showed a significantly lower treatment success in ICU patients compared with non-ICU patients. It is known that in critically ill patients, alterations in function of various organs and body systems can influence the pharmacokinetics and hence the plasma… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Invasive Candidiasis
- How many people
- 19 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2012to Jan 2017
- 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 micafungin.
- Admission to an ICU.
- Age ≥ 18 years.
- Invasive candidiasis.
Who cannot join
- Blood sampling not possible.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetics of Micafungin in Critically Ill Patients With Invasive Candidiasis
A study of micafungin in ICU versus non-ICU patients showed a significantly lower treatment success in ICU patients compared with non-ICU patients. It is known that in critically ill patients, alterations in function of various organs and body systems can influence the pharmacokinetics and hence the plasma concentration of a drug. The pharmacokinetic parameters of micafungin in critically ill patients are most likely different, but this has not been specifically studied.
The pharmacokinetic parameters of micafungin in critically ill patients will be established and plasma concentrations of micafungin will be correlated with disease severity.
- Conditions
- Critical Illness, Invasive Candidiasis
- Keywords
- Micafungin, pharmacokinetics, invasive candidiasis, intensive care
- Medical subject headings
- Critical Illness, Candidiasis, Invasive
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 |
|---|---|---|
| Micafungin | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of pharmacokinetic parameters/plasma concentrations of micafungin with disease severity.
Correlation of the level of micafungin concentration with disease severity scores. Correlation of pharmacokinetic parameters (clearance, half-life) of micafungin with disease severity scores.
Measured: 4 days
Secondary outcomes (7)
Pharmacokinetic parameters of micafungin in ICU patients.
Calculate the pharmacokinetic parameters (clearance, half life, volume of distribution) of micafungin.
Measured: 4 days
Time (in days) to culture conversion.
Number of days untill cultures are negative.
Measured: max 28 days
Correlation of the plasma concentration of micafungin with response to treatment.
Correlation of the level of micafungin concentration with outcome.
Measured: max 28 days
Correlation of the plasma concentration of micafungin with inflammation parameters.
Correlation of the level of micafungin concentration with interleukin-6, interleukin-8 and procalcitonin.
Measured: 4 days
Area under the concentration-time curve (AUC)/minimal inhibitory concentration (MIC) ratio.
Area under the concentration-time curve of micafungin devided by the minimal inhibitory concentration of the candida species.
Measured: max 28 days
Composing a pharmacokinetic model of micafungin in critically ill patients.
Composing a pharmacokinetic model of micafungin to estimate the 24-hours AUC of micafungin based on limited samples.
Measured: max 28 days
Highest observed plasma concentration (Cmax)/minimal inhibitory concentration (MIC) ratio.
Highest observed plasma concentration of micafungin devided by the minimal inhibitory concentration of the candida species.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2016
- Study completionJan 2017
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 Critical IllnessStudies 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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan-Willem C Alffenaar, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01716988
- Sponsor's protocol ID
- NL39246.042.12
- Status last verified
- Jan 2017
- First submitted
- 8 Oct 2012
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Boonstra JM, van der Elst KC, Veringa A, Jongedijk EM, Bruggemann RJ, Koster RA, Kampinga GA, Kosterink JG, van der Werf TS, Zijlstra JG, Touw DJ, Alffenaar JWC. Pharmacokinetic Properties of Micafungin in Critically Ill Patients Diagnosed with Invasive Candidiasis. Antimicrob Agents Chemother. 2017 Nov 22;61(12):e01398-17. doi: 10.1128/AAC.01398-17. Print 2017 Dec.
PubMed 28971861
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Micafungin in Critically Ill Patients With Invasive Candidiasis
- ClinicalTrials.gov ID
- NCT01716988
- Acronym / sponsor ID
- NL39246.042.12
- Conditions
- Critical Illness, Invasive Candidiasis
- Keywords
- Micafungin, pharmacokinetics, invasive candidiasis, intensive care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 30 Oct 2012 (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.
A study of micafungin in ICU versus non-ICU patients showed a significantly lower treatment success in ICU patients compared with non-ICU patients. It is known that in critically ill patients, alterations in function of various organs and body systems can influence the pharmacokinetics and hence the plasma concentration of a drug. The pharmacokinetic parameters of micafungin in critically ill patients are most likely different, but this has not been specifically studied.
The pharmacokinetic parameters of micafungin in critically ill patients will be established and plasma concentrations of micafungin will be correlated with disease severity.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Micafungin | – | – |
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 micafungin.
- Admission to an ICU.
- Age ≥ 18 years.
- Invasive candidiasis.
Key exclusion criteria (1 listed)
- Blood sampling not possible.
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
Correlation of pharmacokinetic parameters/plasma concentrations of micafungin with disease severity.
Time frame: 4 days
Correlation of the level of micafungin concentration with disease severity scores. Correlation of pharmacokinetic parameters (clearance, half-life) of micafungin with disease severity scores.
7 secondary outcomes
Pharmacokinetic parameters of micafungin in ICU patients.
Time frame: 4 days
Time (in days) to culture conversion.
Time frame: max 28 days
Correlation of the plasma concentration of micafungin with response to treatment.
Time frame: max 28 days
Correlation of the plasma concentration of micafungin with inflammation parameters.
Time frame: 4 days
Area under the concentration-time curve (AUC)/minimal inhibitory concentration (MIC) ratio.
Time frame: max 28 days
Composing a pharmacokinetic model of micafungin in critically ill patients.
Time frame: max 28 days
Highest observed plasma concentration (Cmax)/minimal inhibitory concentration (MIC) ratio.
Time frame: 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 12 Jan 2017.
- Derived from this study: PubMed 28971861Boonstra JM, van der Elst KC, Veringa A, Jongedijk EM, Bruggemann RJ, Koster RA, Kampinga GA, Kosterink JG, van der Werf TS, Zijlstra JG, Touw DJ, Alffenaar JWC. Pharmacokinetic Properties of Micafungin in Critically Ill Patients Diagnosed with Invasive Candidiasis. Antimicrob Agents Chemother. 2017 Nov 22;61(12):e01398-17. doi: 10.1128/AAC.01398-17. Print 2017 Dec.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Critical Illness and Invasive Candidiasis, 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 1 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 12 Jan 2017. 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?
Correlation of pharmacokinetic parameters/plasma concentrations of micafungin with disease severity. (time frame: 4 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 NCT01716988, 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 12 Jan 2017.