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Modified Release Posaconazole in Patients With Cystic Fibrosis

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ClinicalTrials.gov Identifier: NCT03421366
Recruitment Status : Not yet recruiting
First Posted : February 5, 2018
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
Bayside Health

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.

Condition or disease Intervention/treatment
Cystic Fibrosis Drug: Posaconazole

Detailed Description:

Use of antifungals has increased in people with cystic fibrosis. Aspergillus is the dominant fungal pathogen in this patient population and thus far, voriconazole has been used first line. Apart from recurrent and chronic lung infections, people with cystic fibrosis can also have problems with their gastrointestinal tract and absorption, and can develop chronic liver disease. As a consequence, they are at high-risk for not achieving adequate antifungal levels, which may be due to altered oral bioavailability, and they may be more susceptible to hepatic toxicities.

This study will evaluate the use of the newer modified release, once daily formulation of posaconazole in people with cystic fibrosis to identify if there is any difference in the bioavailability of the drug due to the effect of cystic fibrosis on the gastrointestinal tract. This newer formulation of once daily posaconazole is approved by the Therapeutic Goods Administration (TGA) and available on the Pharmaceutical Benefits Scheme (PBS) since March 2015. The newer formulation has the potential to overcome one of the major challenges with antifungals in cystic fibrosis; oral bioavailability. Posaconazole also appears to have reduced hepatotoxicity. This study will focus on the safety and tolerability of the drug, as well as pharmacological and microbiological endpoints.

20 eligible participants will be enrolled and have a

  • Pre-treatment sputum will be collected as standard of care.
  • Posaconazole serum levels will be taken at days 2, 5 and 7. (Day 5 and 7 as standard of care).
  • renal and liver function assessed whilst on treatment as standard of care.
  • followed up for 30 days to assess tolerability and monitor for the development of liver toxicity

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Modified Release Posaconazole in Patients With Cystic Fibrosis
Estimated Study Start Date : February 5, 2018
Estimated Primary Completion Date : February 5, 2019
Estimated Study Completion Date : February 5, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Group/Cohort Intervention/treatment
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.
Drug: Posaconazole
A triazole antifungal drug that is used to treat invasive infections by Candida species and Aspergillus species in severely immunocompromised patients




Primary Outcome Measures :
  1. Serum levels of posaconazole in patients with cystic fibrosis taking the newer modified release once daily oral formulation. [ Time Frame: 7 days ]
    Posaconazole serum levels at days 2, 5 and 7


Biospecimen Retention:   Samples Without DNA
As standard of care a pre-treatment sputum is collected for fungal cultures. The Aspergillus isolates collected will be retained and stored frozen for future testing of posaconazole susceptibility and whole genome sequencing to characterize clonal types and virulence properties


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with cystic fibrosis attending care at the Alfred Hospital in Melbourne Australia
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.

Exclusion Criteria:

  • • Known azole hypersensitivity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03421366


Contacts
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Contact: Janine Roney, BHSc RN MPH +61390762296 j.roney@alfred.org.au
Contact: Anton Peleg, MBBS FRACP PhD +61390763009 anton.peleg@monash.edu

Sponsors and Collaborators
Bayside Health

Additional Information:
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Responsible Party: Bayside Health
ClinicalTrials.gov Identifier: NCT03421366     History of Changes
Other Study ID Numbers: 432.17
First Posted: February 5, 2018    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Bayside Health:
posaconazole
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Posaconazole
Antifungal Agents
Anti-Infective Agents
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs