Modified Release Posaconazole in Patients With Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

Modified Release Posaconazole in Patients With Cystic Fibrosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03421366
• Other study ID #: 432.17
• Status: Recruiting
• Start date: March 1, 2018
• Est. completion date: February 5, 2021

Study information

• Verified date: October 2020
• Source: Bayside Health
• Contact: Janine Roney, BHSc RN MPH
• Phone: +61390762296
• Email: j.roney[@]alfred.org.au
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 5, 2021
• Est. primary completion date: February 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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

Related Conditions & MeSH terms

• Cystic Fibrosis
• 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

Locations

Country	Name	City	State
Australia	Alfred Hospital	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Bayside Health

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum levels of posaconazole in patients with cystic fibrosis taking the newer modified release once daily oral formulation.	Posaconazole serum levels at days 2, 5 and 7	7 days

External Links

•   Green MR, Wollery JE. Posaconazole Serum Level on Day 2 Predicts Steady State Posaconazole Serum level. Ther Drug Monit • Volume 34, Number 1, February 2012
•   Rey E, Treluyer J, Pons G. Drug Dispostion in Cysytic Fibrosis. Clin Pharmacokinet 1998 Oct; 35 (4): 313-329
•   Zhang H, Nguyen M, Clancy J et al. Pharmacokinetics of Posaconazole Suspension in Lung Transplant Patients with and without Cystic Fibrosis. Antimicrob Agents Chemother. 2016 Jun; 60(6): 3558-3562