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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03421366 |
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Date of registration:
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27/12/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Modified Release Posaconazole in Patients With Cystic Fibrosis
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Scientific title:
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Modified Release Posaconazole in Patients With Cystic Fibrosis |
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Date of first enrolment:
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March 1, 2018 |
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Target sample size:
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20 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03421366 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Australia
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Contacts
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Name:
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Janine Roney |
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Address:
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Telephone:
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+61390762296 |
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Email:
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j.roney@alfred.org.au |
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Affiliation:
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Name:
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Janine Roney, BHSc RN MPH |
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Address:
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Telephone:
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+61390762296 |
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Email:
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j.roney@alfred.org.au |
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Affiliation:
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Key inclusion & exclusion criteria
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- 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.
Exclusion Criteria:
- • Known azole hypersensitivity
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Intervention(s)
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Drug: Posaconazole
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Primary Outcome(s)
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Serum levels of posaconazole in patients with cystic fibrosis taking the newer modified release once daily oral formulation.
[Time Frame: 7 days]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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