Cystic FibrosisNCT03421366
Modified Release Posaconazole in Patients With Cystic Fibrosis
An observational study of Cystic Fibrosis, run by Bayside Health at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Posaconazole
- Type of treatment
- Pill or oral medicine
- How many people
- 20 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Mar 2018to 5 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with cystic fibrosis attending care at the Alfred Hospital in Melbourne Australia
Who may be able to join
None listed.
Who cannot join
- • Known azole hypersensitivity
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Alfred Hospital
Melbourne, Victoria, 3004
Janine Roney, +61390762296, j.roney@alfred.org.au
A Peleg, Prof
About this study
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.
Read the 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
- Conditions
- Cystic Fibrosis
- Being tested
- Posaconazole
- Keywords
- posaconazole
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PosaconazoleDrug
A triazole antifungal drug that is used to treat invasive infections by Candida species and Aspergillus species in severely immunocompromised patients
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Posaconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start1 Mar 2018
- Primary completion5 Feb 2021 (estimated)
- Study completion5 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayside Health
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03421366
- Sponsor's protocol ID
- 432.17
- Status last verified
- Oct 2020
- First submitted
- 27 Dec 2017
- Last updated
- 26 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Release Posaconazole in Patients With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT03421366
- Acronym / sponsor ID
- 432.17
- Conditions
- Cystic Fibrosis
- Keywords
- posaconazole
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Bayside HealthOther government
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 5 Feb 2021 (estimated)
- Study completion
- 5 Feb 2021 (estimated)
- First posted
- 5 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cystic Fibrosis on Posaconazole | – | Drug: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cystic fibrosis attending care at the Alfred Hospital in Melbourne Australia
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- • Known azole hypersensitivity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PosaconazoleA triazole antifungal drug that is used to treat invasive infections by Candida species and Aspergillus species in severely immunocompromised patients | Drug | Cystic Fibrosis on Posaconazole |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2020.
- Rey E, Treluyer J, Pons G. Drug Dispostion in Cysytic Fibrosis. Clin Pharmacokinet 1998 Oct; 35 (4): 313-329Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Bayside Health at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Janine Roney, BHSc RN MPH (+61390762296, j.roney@alfred.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum levels of posaconazole in patients with cystic fibrosis taking the newer modified release once daily oral formulation. (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2020.