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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03717623




Registration number
NCT03717623
Ethics application status
Date submitted
10/10/2018
Date registered
24/10/2018
Date last updated
29/03/2023

Titles & IDs
Public title
Posaconazole Pharmacokinetics in Patients Receiving Chemotherapy or Stem Cell Transplants
Scientific title
Pharmacokinetics Study of Posaconazole in Haematology Patients Receiving Standard of Care Treatment With Oral Posaconazole Prophylaxis for Invasive Fungal Infection
Secondary ID [1] 0 0
2017.105
Universal Trial Number (UTN)
Trial acronym
POPULAR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Posaconazole 0 0
Pharmacokinetics 0 0
Invasive Candidiases 0 0
Invasive Aspergillosis 0 0
Invasive Mycosis 0 0
Fungal Infection 0 0
Prophylaxis 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Posaconazole pharmacokinetics

Experimental: Posaconazole prophylaxis - Blood samples will be taken from participants undergoing cancer treatment and receiving Posaconazole prophylaxis. The samples will be used for Posaconazole pharmacokinetics study.


Treatment: Drugs: Posaconazole pharmacokinetics
Blood samples will be collected on Days 7, 14 and 21 from the onset of Posaconazole prophylactic treatment If significant diarrhoea occurs, additional blood samples will be collected twice weekly until symptoms resolve. All blood samples will be used for Posaconazole pharmacokinetics study.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pre-dose plasma Posaconazole concentrations
Timepoint [1] 0 0
On days 7, 14 and 21 of Posaconazole prophylaxis course, when significant diarrhea occurs, when active gastrointestinal graft versus host disease occurs.
Secondary outcome [1] 0 0
Clinical symptoms affecting plasma Posaconazole concentrations.
Timepoint [1] 0 0
At Screening, Days 7, 14 and 21, and 72 hours after onset of diarrhoea, and when invasive fungal infection occurs.
Secondary outcome [2] 0 0
The number/proportion of patients achieving desirable pre-dose plasma Posaconazole concentrations.
Timepoint [2] 0 0
On days 7, 14 and 21 of Posaconazole prophylaxis course, when significant diarrhea occurs, when active gastrointestinal graft versus host disease occurs.
Secondary outcome [3] 0 0
Effects of diarrhea on plasma Posaconazole concentration
Timepoint [3] 0 0
When diarrhea occurs during Posaconazole prophylaxis on Days 1 to 21.
Secondary outcome [4] 0 0
Alteration in prophylaxis due to Posaconazole-attributed toxicities.
Timepoint [4] 0 0
When change in or cessation of oral Posaconazole prophylaxis occurs during Day 1 to Day 21.

Eligibility
Key inclusion criteria
- Adult (=18 years old) haematology patients receiving Posaconazole prophylaxis in the
inpatient setting as standard of care.

- Able to give informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Unable to give informed consent.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/12/2023
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Melbourne Health - Parkville
Recruitment postcode(s) [1] 0 0
3050 - Parkville

Funding & Sponsors
Primary sponsor type
Other
Name
Melbourne Health
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Merck Sharp & Dohme LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of the study is to investigate the pharmacokinetics of oral dosage of
Posaconazole which is routinely administered as a standard care prophylaxis for patients
undergoing cancer treatments.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03717623
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Monica Slavin, Prof
Address 0 0
Country 0 0
Phone 0 0
61 3 9342 9403
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03717623