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Trial record 9 of 1244 for:    cystic fibrosis

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

Tracking Information
First Submitted Date December 27, 2017
First Posted Date February 5, 2018
Last Update Posted Date February 5, 2018
Estimated Study Start Date February 5, 2018
Estimated Primary Completion Date February 5, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 29, 2018)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Modified Release Posaconazole in Patients With Cystic Fibrosis
Official Title Modified Release Posaconazole in Patients With Cystic Fibrosis
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.
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
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
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
Sampling Method Non-Probability Sample
Study Population Patients with cystic fibrosis attending care at the Alfred Hospital in Melbourne Australia
Condition Cystic Fibrosis
Intervention Drug: Posaconazole
A triazole antifungal drug that is used to treat invasive infections by Candida species and Aspergillus species in severely immunocompromised patients
Study Groups/Cohorts 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.
Intervention: Drug: Posaconazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: January 29, 2018)
20
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 5, 2020
Estimated Primary Completion Date February 5, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Janine Roney, BHSc RN MPH +61390762296 j.roney@alfred.org.au
Contact: Anton Peleg, MBBS FRACP PhD +61390763009 anton.peleg@monash.edu
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03421366
Other Study ID Numbers 432.17
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement Not Provided
Responsible Party Bayside Health
Study Sponsor Bayside Health
Collaborators Not Provided
Investigators Not Provided
PRS Account Bayside Health
Verification Date December 2017