CandidiasisPACIFICNCT02666716
Pharmacokinetics of Fluconazole IV as Prophylaxis or Therapy to ICU Patients
An observational study of Candidiasis, run by Radboud University Medical Center at 3 sites in Netherlands.
Trial summary
The pharmacokinetics of fluconazole are expected to be different in ICU patients compared to non-ICU patients. The investigators will determine fluconazole and free fluconazole concentrations in 20 ICU patients, who will get intravenous fluconazole as standard care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Candidiasis
- What is being tested?
- fluconazole
- How many people
- 20 participants
- Where
- 3 sitesNetherlands
- Study dates
- May 2015to Mar 2016
- 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: All patients receiving fluconazole as prophylaxis or therapy for an (invasive) fungal infection at the ICU will be included.
Who may be able to join
- Patient is admitted to an ICU
- Subject is at least 18 years of age on the day of the first dosing
- Subject is managed with a central venous or arterial catheter
Who cannot join
- Is known to be hypersensitive to azole antifungal agents
- Documented history of sensitivity to medicinal products or excipients similar to those found in the fluconazole preparation
- Has previously participated in this trial
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Canisius Wilhelmina Ziekenhuis
Nijmegen
Radboud university medical center
Nijmegen
University Medical Center Utrecht
Utrecht
About this study
Official title: Pharmacokinetics of Fluconazole Given Intravenously as Prophylaxis or Therapy to Patients With an Invasive Fungal Infection in the Intensive Care Unit (PACIFIC)
The pharmacokinetics of fluconazole are expected to be different in ICU patients compared to non-ICU patients. The investigators will determine fluconazole and free fluconazole concentrations in 20 ICU patients, who will get intravenous fluconazole as standard care. Switching to oral/enteral fluconazol is allowed after day 3.
A full pharmacokinetic curve will be taken on day 3 of iv therapy and limited pharmacokinetic curves on day 7 of iv therapy and/or on day 3 of oral therapy; trough levels will be taken daily after intravenous therapy.
Read the detailed description
The pharmacokinetics of fluconazole are expected to be different in ICU patients compared to non-ICU patients and healthy volunteers due to underlying disease(s). Therefore, extrapolation of data from healthy volunteers and non-ICU patients is not possible.
To be able to include 20 patients within the study duration, a multi-centre approach is necessary.
Patients will receive standard care, as stated in the product characteristics or according to local protocols. Blood sampling for pharmacokinetic analysis will be retrieved through a central venous catheter. A maximum of 62 milliliter blood in total will be drawn for this study. Patients will be monitored daily during the treatment period for adverse events of the study drug.
Full pharmacokinetic curves will be taken on day 3 of iv therapy. Limited pharmacokinetic curves will be taken on day 7 of iv therapy. These two moments of pharmacokinetic analysis will enable the determination steady state and enable the determination of intra-individual variability.
As probably not all patients included will be treated with iv fluconazole for 7 days, switching to oral/enteral therapy is allowed after day 3. To assess bioavailability limited pharmacokinetic curves will be taken on day 3 of oral/enteral therapy.
- Conditions
- Candidiasis
- Being tested
- fluconazole
- Keywords
- pharmacokinetics, fluconazole, invasive fungal infection, candidiasis, intensive care unit
- Medical subject headings
- Candidiasis, Invasive Fungal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluconazoleDrug
Also called Diflucan
Dose according to summary of product characteristics (SPC) or local protocols
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve
Full pharmacokinetic curves will be taken op Day 3 and Day 7 (fluconazole).
Measured: Days 3 and 7
Secondary outcomes (1)
body weight
Identifying influence of body weight on the pharmacokinetics of fluconazole.
Measured: Days 3 and 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startMay 2015
- Primary completionMar 2016
- Study completionMar 2016
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 CandidiasisStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roger Brüggemann, PharmD, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02666716
- Sponsor's protocol ID
- UMCN-AKF14.06
- Acronym
- PACIFIC
- Status last verified
- Dec 2020
- First submitted
- 12 Aug 2015
- Last updated
- 7 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Muilwijk EW, de Lange DW, Schouten JA, Wasmann RE, Ter Heine R, Burger DM, Colbers A, Haas PJ, Verweij PE, Pickkers P, Bruggemann RJ. Suboptimal Dosing of Fluconazole in Critically Ill Patients: Time To Rethink Dosing. Antimicrob Agents Chemother. 2020 Sep 21;64(10):e00984-20. doi: 10.1128/AAC.00984-20. Print 2020 Sep 21.
PubMed 32816723
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Fluconazole Given Intravenously as Prophylaxis or Therapy to Patients With an Invasive Fungal Infection in the Intensive Care Unit (PACIFIC)
- ClinicalTrials.gov ID
- NCT02666716
- Acronym / sponsor ID
- PACIFIC / UMCN-AKF14.06
- Conditions
- Candidiasis
- Keywords
- pharmacokinetics, fluconazole, invasive fungal infection, candidiasis, intensive care unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 28 Jan 2016 (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 pharmacokinetics of fluconazole are expected to be different in ICU patients compared to non-ICU patients. The investigators will determine fluconazole and free fluconazole concentrations in 20 ICU patients, who will get intravenous fluconazole as standard care. Switching to oral/enteral fluconazol is allowed after day 3.
A full pharmacokinetic curve will be taken on day 3 of iv therapy and limited pharmacokinetic curves on day 7 of iv therapy and/or on day 3 of oral therapy; trough levels will be taken daily after intravenous therapy.
Detailed description
The pharmacokinetics of fluconazole are expected to be different in ICU patients compared to non-ICU patients and healthy volunteers due to underlying disease(s). Therefore, extrapolation of data from healthy volunteers and non-ICU patients is not possible.
To be able to include 20 patients within the study duration, a multi-centre approach is necessary.
Patients will receive standard care, as stated in the product characteristics or according to local protocols. Blood sampling for pharmacokinetic analysis will be retrieved through a central venous catheter. A maximum of 62 milliliter blood in total will be drawn for this study. Patients will be monitored daily during the treatment period for adverse events of the study drug.
Full pharmacokinetic curves will be taken on day 3 of iv therapy. Limited pharmacokinetic curves will be taken on day 7 of iv therapy. These two moments of pharmacokinetic analysis will enable the determination steady state and enable the determination of intra-individual variability.
As probably not all patients included will be treated with iv fluconazole for 7 days, switching to oral/enteral therapy is allowed after day 3. To assess bioavailability limited pharmacokinetic curves will be taken on day 3 of oral/enteral therapy.
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
- All patients receiving fluconazole as prophylaxis or therapy for an (invasive) fungal infection at the ICU will be included.
Key inclusion criteria (3 listed)
- Patient is admitted to an ICU
- Subject is at least 18 years of age on the day of the first dosing
- Subject is managed with a central venous or arterial catheter
Key exclusion criteria (3 listed)
- Is known to be hypersensitive to azole antifungal agents
- Documented history of sensitivity to medicinal products or excipients similar to those found in the fluconazole preparation
- 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fluconazoleAlso: DiflucanDose according to summary of product characteristics (SPC) or local protocols | Drug | – |
Primary outcome
Area under the curve
Time frame: Days 3 and 7
Full pharmacokinetic curves will be taken op Day 3 and Day 7 (fluconazole).
1 secondary outcome
body weight
Time frame: Days 3 and 7
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 7 Dec 2020.
- Results publication: PubMed 32816723Muilwijk EW, de Lange DW, Schouten JA, Wasmann RE, Ter Heine R, Burger DM, Colbers A, Haas PJ, Verweij PE, Pickkers P, Bruggemann RJ. Suboptimal Dosing of Fluconazole in Critically Ill Patients: Time To Rethink Dosing. Antimicrob Agents Chemother. 2020 Sep 21;64(10):e00984-20. doi: 10.1128/AAC.00984-20. Print 2020 Sep 21.
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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.
Roger Brüggemann, PharmD, PhD principal investigator
Radboud University Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Candidiasis, run by Radboud University Medical Center at 3 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 3 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 7 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
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?
Area under the curve (time frame: Days 3 and 7). 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 NCT02666716, 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 7 Dec 2020.