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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/NCT03421366




Registration number
NCT03421366
Ethics application status
Date submitted
27/12/2017
Date registered
5/02/2018
Date last updated
26/10/2020

Titles & IDs
Public title
Modified Release Posaconazole in Patients With Cystic Fibrosis
Scientific title
Modified Release Posaconazole in Patients With Cystic Fibrosis
Secondary ID [1] 0 0
432.17
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Cystic fibrosis
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Posaconazole

Cystic Fibrosis on Posaconazole - Able to provide written informed consent
Greater than 18 years of age or older
Have a diagnosis of cystic fibrosis
No known azole hypersensitivity
To commence as part of their standard of care the newer modified release oral formulation of posaconazole to treat Aspergillus
Able to provide a pre-treatment sputum collected for fungal culture as part of standard of care
Have been prescribed a loading dose of 300mg bd for 1 day of the modified release posaconazole tablet followed by 300mg daily.


Treatment: Drugs: Posaconazole
A triazole antifungal drug that is used to treat invasive infections by Candida species and Aspergillus species in severely immunocompromised patients
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Serum levels of posaconazole in patients with cystic fibrosis taking the newer modified release once daily oral formulation.
Timepoint [1] 0 0
7 days

Eligibility
Key inclusion criteria
- Albe to provide written informed consent

- Greater than 18 years of age or older

- Have a diagnosis of cystic fibrosis

- To commence as part of their standard of care the newer modified release oral
formulation of posaconazole to treat Aspergillus

- Able to provide a pre-treatment sputum collected for fungal culture as part of
standard of care

- Have been prescribed a loading dose of 300mg bd for 1 day of the modified release
posaconazole tablet followed by 300mg daily.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- • Known azole hypersensitivity

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
5/02/2021
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Bayside Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
A prospective single center observational cohort of patients with cystic fibrosis to
determine whether adequate serum levels of posaconazole, after administration of the newer
modified release once daily oral formulation, can be achieved.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03421366
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
Janine Roney, BHSc RN MPH
Address 0 0
Country 0 0
Phone 0 0
+61390762296
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/NCT03421366