Invasive Fungal InfectionCASCADENCT01533558
Pharmacokinetics of Caspofungin (Cancidas ®) Given Intravenously as Therapy to Patients With an Invasive Fungal Infection in the Intensive Care Unit - a Search for Co-variates
An observational study of Invasive Fungal Infection, run by Radboud University Medical Center at 4 sites in Netherlands.
Trial summary
The pharmacokinetics of caspofungin are expected to be different in ICU patients compared to non-ICU patients. The investigators will determine caspofungin concentrations in 20 ICU patients, who will get caspofungin as standard care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Fungal Infection
- What is being tested?
- caspofungin
- How many people
- 20 participants
- Where
- 4 sitesNetherlands
- Study dates
- Jan 2012to Jun 2013
- 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 with invasive fungal infection
Who may be able to join
- Patient is admitted to an ICU
- Subject is at least 18 and not older than 65 years of age on the day of the first dosing
- Subject has been treated with caspofungin for a maximum of two days before enrolment in this trial
- Is managed with a central venous catheter
Who cannot join
- Is known to be hypersensitive to echinocandin antifungal agents
- Documented history of sensitivity to medicinal products or excipients similar to those found in the caspofungin preparation
- Positive HIV test or hepatitis B or C test
- History of QT time prolongation
- History of or current abuse of drugs, alcohol or solvents
- Has previously participated in this trial
Trial locations and contacts
4 sites in 1 country.
Netherlands4 sites
Rijnstate Hospital
Arnhem
Canisius Wilhelmina Hospital (CWZ)
Nijmegen
Radboud University Nijmegen Medical Centre
Nijmegen
University Medical Centre Utrecht
Utrecht
About this study
The pharmacokinetics of caspofungin are expected to be different in ICU patients compared to non-ICU patients. The investigators will determine caspofungin concentrations in 20 ICU patients, who will get caspofungin as standard care.
Full PK curves will be taken on day 3 and a limited PK curve on day 7, trough levels will be taken daily.
Read the detailed description
The pharmacokinetics of caspofungin 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 SPC or according to local protocols. Blood sampling for PK analysis will be retrieved through a central venous catheter. Approximately 60mL will be drawn in total for this study. Patients will be monitored daily during the treatment period for adverse events of the study drug.
Although steady state of caspofungin will be achieved after approximately 14 days of treatment, full PK curves will be taken on day 3. As probably not all patients included will be treated with caspofungin for 14 days, taking full PK curves on day 14 is considered not feasible. These two moments of PK analysis will enable the determination steady state and enable the determination of intra-individual variability.
- Conditions
- Invasive Fungal Infection
- Being tested
- caspofungin
- Keywords
- caspofungin, pharmacokinetics, invasive fungal infection, candidiasis, aspergillosis, intensive care
- Medical subject headings
- Invasive Fungal Infections, Candidiasis, Aspergillosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caspofunginDrug
Also called Cancidas
normal dosage for caspofungin, not adapted for the study
| Study group | Role | What they receive |
|---|---|---|
| caspofungin | caspofungin dosing Receives: Drug: caspofungin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under Curve (AUC)
AUC0-tau, AUC0-inf (Time Frame: predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 20 and 24 hours post-dose on Day 3 and predose, 1, 4, 8, 12 hours + 6 days after the dose on Day 7) of caspofungin
Measured: day 3 and day 7
Secondary outcomes (2)
co-variates influencing PK of caspofungin
identify co-variates of influence on the pharmacokinetics of caspofungin
Measured: day 3 and day 7
Number of Participants with Adverse Events
the adverse events will be recorded in IC patients during the study
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionMay 2013
- Study completionJun 2013
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 Fungal InfectionStudies 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, PhD, PharmD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01533558
- Sponsor's protocol ID
- AKF UMCN 11.02
- Acronym
- CASCADE
- Status last verified
- Nov 2020
- First submitted
- 19 Jan 2012
- Last updated
- 1 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Muilwijk EW, Schouten JA, van Leeuwen HJ, van Zanten AR, de Lange DW, Colbers A, Verweij PE, Burger DM, Pickkers P, Bruggemann RJ. Pharmacokinetics of caspofungin in ICU patients. J Antimicrob Chemother. 2014 Dec;69(12):3294-9. doi: 10.1093/jac/dku313. Epub 2014 Aug 19.
PubMed 25139840
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Caspofungin (Cancidas ®) Given Intravenously as Therapy to Patients With an Invasive Fungal Infection in the Intensive Care Unit - a Search for Co-variates
- ClinicalTrials.gov ID
- NCT01533558
- Acronym / sponsor ID
- CASCADE / AKF UMCN 11.02
- Conditions
- Invasive Fungal Infection
- Keywords
- caspofungin, pharmacokinetics, invasive fungal infection, candidiasis, aspergillosis, intensive care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 15 Feb 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.
The pharmacokinetics of caspofungin are expected to be different in ICU patients compared to non-ICU patients. The investigators will determine caspofungin concentrations in 20 ICU patients, who will get caspofungin as standard care.
Full PK curves will be taken on day 3 and a limited PK curve on day 7, trough levels will be taken daily.
Detailed description
The pharmacokinetics of caspofungin 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 SPC or according to local protocols. Blood sampling for PK analysis will be retrieved through a central venous catheter. Approximately 60mL will be drawn in total for this study. Patients will be monitored daily during the treatment period for adverse events of the study drug.
Although steady state of caspofungin will be achieved after approximately 14 days of treatment, full PK curves will be taken on day 3. As probably not all patients included will be treated with caspofungin for 14 days, taking full PK curves on day 14 is considered not feasible. These two moments of PK analysis will enable the determination steady state and enable the determination of intra-individual variability.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| caspofungin | – | Drug: caspofungincaspofungin dosing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- intensive care patients with invasive fungal infection
Key inclusion criteria (4 listed)
- Patient is admitted to an ICU
- Subject is at least 18 and not older than 65 years of age on the day of the first dosing
- Subject has been treated with caspofungin for a maximum of two days before enrolment in this trial
- Is managed with a central venous catheter
Key exclusion criteria (6 listed)
- Is known to be hypersensitive to echinocandin antifungal agents
- Documented history of sensitivity to medicinal products or excipients similar to those found in the caspofungin preparation
- Positive HIV test or hepatitis B or C test
- History of QT time prolongation
- History of or current abuse of drugs, alcohol or solvents
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 |
|---|---|---|
| caspofunginAlso: Cancidasnormal dosage for caspofungin, not adapted for the study | Drug | caspofungin |
Primary outcome
Area Under Curve (AUC)
Time frame: day 3 and day 7
AUC0-tau, AUC0-inf (Time Frame: predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 20 and 24 hours post-dose on Day 3 and predose, 1, 4, 8, 12 hours + 6 days after the dose on Day 7) of caspofungin
2 secondary outcomes
co-variates influencing PK of caspofungin
Time frame: day 3 and day 7
Number of Participants with Adverse Events
Time frame: 14 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 1 Dec 2020.
- Results publication: PubMed 25139840Muilwijk EW, Schouten JA, van Leeuwen HJ, van Zanten AR, de Lange DW, Colbers A, Verweij PE, Burger DM, Pickkers P, Bruggemann RJ. Pharmacokinetics of caspofungin in ICU patients. J Antimicrob Chemother. 2014 Dec;69(12):3294-9. doi: 10.1093/jac/dku313. Epub 2014 Aug 19.
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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, PhD, PharmD principal investigator
Radboud University Medical Center
4 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 Fungal Infection, run by Radboud University Medical Center at 4 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 4 inclusion and 6 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 1 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 4 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 Curve (AUC) (time frame: day 3 and day 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 NCT01533558, 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 1 Dec 2020.