Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000997752p
Ethics application status
Submitted, not yet approved
Date submitted
3/04/2022
Date registered
15/07/2022
Date last updated
15/07/2022
Date data sharing statement initially provided
15/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
interindividual variability and intraindividual variability of antimycotic concentrations in individuals receiving treatment for mycotic infections
Scientific title
Interindividual variability and intraindividual variability of antimycotic concentrations in individuals receiving treatment for mycotic infections
Secondary ID [1] 306826 0
none
Universal Trial Number (UTN)
Trial acronym
none
Linked study record

Health condition
Health condition(s) or problem(s) studied:
aspergillus infection 325910 0
mycotic infection 325911 0
Condition category
Condition code
Infection 323226 323226 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
this study will only review patients who have already been prescribed voriconazole to treat their infection.
the dose of voriconazole administered, 200 mg twice daily; the mode of administration, oral tablet.
the duration of administration, 12 months; All participants who have received voriconazole will be included in the study, and will be observed for up to 12 months after commencing voriconazole.
only data from medical records will be collected for the study: renal function and liver function (drug induced kidney or liver dysfunction)
blood voriconazole concentrations from medical records only
The records of all patients admitted to University Hospital Motol between 1/01/2020 and 30/06/2022 will be reviewed,
Intervention code [1] 323494 0
Diagnosis / Prognosis
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330975 0
Primary outcome 1: all-patients treatment with tablet voriconazole , concentration of voriconazole measured using a blood sample
voriconazole concentrations will only be assessed by looking at medical records
Timepoint: at one year
Information regarding analysis of this outcome to determine inter- and intraindividual variability
Timepoint [1] 330975 0
Baseline 1 year post-intervention commencement
Secondary outcome [1] 408324 0
liver function tests from medical records - descriptive statistics
Timepoint [1] 408324 0
"Baseline, 1 year after initiation of voriconazole",
Secondary outcome [2] 411374 0
renal function tests from medical records - descriptive statistics
Timepoint [2] 411374 0
baseline 1 year after initiation of voriconazole

Eligibility
Key inclusion criteria
adult patients, patients treatment with voriconazole, agreement with study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
none

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2022
Actual
Date of last participant enrolment
Anticipated
1/05/2023
Actual
Date of last data collection
Anticipated
1/05/2024
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 24703 0
Czech Republic
State/province [1] 24703 0
Prague

Funding & Sponsors
Funding source category [1] 311157 0
Hospital
Name [1] 311157 0
Univesity Hospital Motol
Country [1] 311157 0
Czech Republic
Funding source category [2] 311158 0
Hospital
Name [2] 311158 0
University Hospital Motol
Country [2] 311158 0
Czech Republic
Primary sponsor type
Hospital
Name
University Hospital Motol
Address
University Hospital Motol
V Úvalu 84/1
150 06 Praha 5
IC: 00064203
DIC: CZ00064203
Country
Czech Republic
Secondary sponsor category [1] 312512 0
None
Name [1] 312512 0
Address [1] 312512 0
Country [1] 312512 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 310685 0
University Hospital Motol ethics committee
Ethics committee address [1] 310685 0
V Úvalu 84/1
150 06 Praha 5
IC: 00064203
DIC: CZ00064203
Ethics committee country [1] 310685 0
Czech Republic
Date submitted for ethics approval [1] 310685 0
01/04/2022
Approval date [1] 310685 0
Ethics approval number [1] 310685 0

Summary
Brief summary
Observation study, 1 years
We observation of concentration of voriconazole by patients with aspergillus infection.
They observation only through concentration of voriconazole 12 month after first dose of voriconazole.
Concentrations of voriconazole will be evaluated. We will evaluated variability of concentrations (inter and intraindividual variability)
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118514 0
Dr Eliška Dvorácková
Address 118514 0
University Hospital Motol
V Úvalu 84/1
Prague 5
150 06
Country 118514 0
Czech Republic
Phone 118514 0
+420 721132330
Fax 118514 0
Email 118514 0
eliskadvorackova@seznam.cz
Contact person for public queries
Name 118515 0
Dr Eliška Dvorácková
Address 118515 0
University Hospital Motol
V Úvalu 84/1
Prague 5
150 06
Country 118515 0
Czech Republic
Phone 118515 0
+420 721132330
Fax 118515 0
Email 118515 0
eliskadvorackova@seznam.cz
Contact person for scientific queries
Name 118516 0
Dr Eliška Dvorácková
Address 118516 0
University Hospital Motol
V Úvalu 84/1
Prague 5
150 06
Country 118516 0
Czech Republic
Phone 118516 0
+420721132330
Fax 118516 0
Email 118516 0
eliskadvorackova@seznam.cz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
individual participant data of published results only
When will data be available (start and end dates)?
start dates 1/6/2022
end dates 1/6/2023
Available to whom?
scientists
Available for what types of analyses?
IPD metaanalysis
How or where can data be obtained?
email of Principal Investigator: eliskadvorackova@lf1cuni.cz


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.