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Fungal InfectionPhase 2UPPRITENCT03561415

Universal Prophylaxis Versus Pre-emptive Therapy With Posaconazole Post-Lung Transplant

A Phase 2 study testing Universal Posaconazole Prophylaxis and Pre-emptive Posaconazole Therapy in people with Fungal Infection, run by Bayside Health at 3 sites in Australia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This trial will examine 2 ways of using the antifungal posaconazole to prevent invasive fungal disease and the precipitation of chronic rejection post lung transplantation. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Fungal Infection
What is being tested?
Universal Posaconazole Prophylaxis and Pre-emptive Posaconazole Therapy
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
3 sitesAustralia
Study dates
2 Jul 2018to 30 Sep 2020
Phase
Phase 2
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

Who may be able to join

  • Male and female aged ≥ 18 years
  • Undergoing bilateral sequential lung transplant (BSLT) or heart-lung transplant (HLT) including re-do transplant
  • Able to give written informed consent
  • Able to understand and comply with all trial requirements

Who cannot join

  • Less than 18 years of age
  • Scheduled to undergo a single-lung transplant (known risk factor for IFD)
  • Scheduled to undergo multi-organ transplant, other than HLT
  • Recipients who will not be followed up for 1-year post-transplant at one of the trial sites
  • Isolation of a mould within the 12 months prior to screening
  • Evidence of a mycetoma within the 12 months prior to screening
Show all 11Show fewer
  • Proven or probable IFD within the 12 months prior to screening
  • Patients with moderate or severe liver disease as defined by aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 times the upper limit of normal (ULN)
  • Any other severe condition which in the site investigator's judgement may interfere with the trial evaluations or severely affect the patients safety
  • Previous inclusion in the trial
  • Currently enrolled in an antifungal or other investigational drug trial

Trial locations and contacts

3 sites in 1 country.

Orla Morrissey contact

+61 3 90762631

o.morrissey@alfred.org.au

Greg Snell contact

+61 90762000

g.snell@alfred.org.au

Australia3 sites

  • The Prince Charles Hospital

    Brisbane, Queensland, 4032

    Peter Hopkins, MD, +61 7 31394000, Peter.Hopkins@health.qld.gov.au

    Daniel Chambers, MD, +61 7 31394000, Daniel.Chambers@health.qld.gov.au

  • Alfred Health

    Melbourne, Victoria, 3004

    Orla Morrissey, MD, PhD, +61 3 90762000, o.morrissey@alfred.org.au

    Greg Snell, MD, + 61 3 90762000, g.snell@alfred.org.au

  • St. Vincent's Hospital

    Sydney, New South Wales, 2010

    Debbie Marriott, MD

    Debbie Marriott, MD

Other trials in Australia

About this study

Official title: Universal Posaconazole Prophylaxis Versus Pre-emptive Posaconazole Therapy for Fungal Infection Management Post-lung Transplantation

This trial will examine 2 ways of using the antifungal posaconazole to prevent invasive fungal disease and the precipitation of chronic rejection post lung transplantation.

Read the detailed description

Lung transplantation (LT) is an increasingly used treatment for end-stage respiratory disease. However, it is expensive, with hospital costs alone estimated at >US$500,000/transplant. Fungal infection and chronic lung allograft dysfunction (CLAD) are the major complications of LT. They pose the greatest threat to long-term survival and are reported to occur in 12-50% of LT recipients and cause death in 21.7-82% of these.

Fungal infections occur in 3 major forms in LT recipients, namely colonisation, trachea-bronchial disease and invasive (or end-organ) disease. Whilst invasive fungal disease (IFD) is associated with the highest mortality, colonisation poses the greatest clinical challenge. It is the most common manifestation, can progress to IFD and can precipitate CLAD. Antifungal prophylaxis is used to minimise the risks associated with colonisation.

Two main antifungal prophylaxis strategies are used. Universal prophylaxis (UP) is defined as the administration of antifungal agents to all patients post-LT. Most centres use UP. A systematic review and meta-analysis showed neither Aspergillus colonisation nor invasive aspergillosis (IA) (the commonest fungal infection in LT recipients) were reduced by UP. Yet it caused side-effects in 29.6%.

The pre-emptive strategy is defined as the administration of antifungal agents when a fungal pathogen (including in donor specimens) is detected or there is serological evidence of a fungal pathogen in the absence of IFD from a post-LT surveillance bronchoscopy or other clinical investigations (i.e. colonisation).Observational data suggest that a pre-emptive strategy has similar IA incidence rates but fewer adverse drug reactions (ADR) than UP (16.1%). It has been estimated that a pre-emptive strategy can reduce antifungal drug use by 43%.

No direct comparison of the efficacy, safety and cost of the two strategies has been performed to date. Thus, a randomised controlled trial (RCT) is needed to determine the optimal strategy to reduce the impact of fungal infection in LT recipients. However, before we embark on a definitive phase III RCT powered for clinical outcomes we will perform a pilot feasibility RCT to generate data and answer practical questions to better inform the design of the definitive phase III RCT powered for clinical outcomes.

Being tested
Universal Posaconazole Prophylaxis, Pre-emptive Posaconazole Therapy
Keywords
Lung transplant, prophylaxis, pre-emptive
Medical subject headings
Mycoses

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Universal Posaconazole ProphylaxisOther

    All patients assigned to this arm will start posaconazole between Day 4 and Day 14 post lung or heart-lung transplant for a minimum of 3 months.

  • Pre-emptive Posaconazole TherapyOther

    Posaconazole will be started if a fungal pathogen is identified or there is serological evidence of a fungal pathogen in the absence of any evidence of invasive fungal disease for 3 months.

Study groups in NCT03561415
Study groupRoleWhat they receive
Universal posaconazole prophylaxisExperimentalUniversal posaconazole prophylaxis: All patients will start posaconazole modified release tablet (300mg daily ) between Day 4 and Day 14 post lung or heart-lung transplantation for 3 months.
Receives: Other: Universal Posaconazole Prophylaxis
Pre-emptive posaconazole therapyExperimentalPre-emptive posaconazole therapy: Posaconazole will be started if a fungal pathogen is identified or there is serological evidence of a fungal pathogen in the absence of any evidence of invasive fungal disease and given for 3 months.
Receives: Other: Pre-emptive Posaconazole Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite of: screened that are eligible, eligible that are enrolled, lost to follow-up or are withdrawn from the trial, receive their allocated treatment throughout the trial participation and have missing data during trial data collection.

    Feasibility outcome

    Measured: 2 years and 3 months

Secondary outcomes (14)

  1. Composite of: at least one episode of fungal pneumonia, fungal tracheobronchitis, or bronchial anastomotic fungal infection; diagnosed as having CLAD or died regardless of cause

    Efficacy outcome

    Measured: 2 years and 3 months

  2. Fungal pneumonia, fungal tracheobronchitis, or bronchial anastomotic fungal infection rates

    Efficacy outcome

    Measured: 2 years and 3 months

  3. CLAD rates

    Efficacy outcome

    Measured: 2 years and 3 months

  4. All-cause mortality rates

    Efficacy outcome

    Measured: 2 years and 3 months

  5. Fungal pneumonia, fungal tracheobronchitis, or bronchial anastomotic fungal infection-related mortality rates

    Efficacy outcome

    Measured: 2 years and 3 months

  6. CLAD-related mortality rates

    Efficacy outcome

    Measured: 2 years and 3 months

  7. Time to development of fungal pneumonia, fungal tracheobronchitis, bronchial anastomotic fungal infection

    Efficacy outcome

    Measured: 2 years and 3 months

  8. Time to diagnosis of CLAD

    Efficacy outcome

    Measured: 2 years and 3 months

  9. Costs associated with allocated arm including number of hospital admissions

    Efficacy outcome

    Measured: 2 years and 3 months

  10. Quality of life (QoL) using Short Form Survey (sf-36) to measure patient health

    Efficacy outcome

    Measured: 2 years and 3 months

  11. Acute rejection rates

    Safety outcome

    Measured: 2 years and 3 months

  12. Posaconazole adverse drug reaction (ADR) rates

    Safety outcome

    Measured: 2 years and 3 months

  13. Proportion of patients who discontinue posaconazole because of an ADR

    Safety outcome

    Measured: 2 years and 3 months

  14. Total duration on posaconazole

    Safety outcome

    Measured: 2 years and 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2018
  2. Study start2 Jul 2018 (estimated)
  3. Primary completion30 Sep 2020 (estimated)
  4. Study completion30 Sep 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03561415
Sponsor's protocol ID
204/17
Acronym
UPPRITE
Status last verified
Jun 2018
First submitted
9 May 2018
Last updated
19 Jun 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Universal Posaconazole Prophylaxis and Pre-emptive Posaconazole Therapy in people with Fungal Infection, run by Bayside Health at 3 sites 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 4 inclusion and 11 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 19 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Orla Morrissey (+61 3 90762631, o.morrissey@alfred.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite of: screened that are eligible, eligible that are enrolled, lost to follow-up or are withdrawn from the trial, receive their allocated treatment throughout the trial participation and have missing data during trial data collection. (time frame: 2 years and 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03561415.

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 19 Jun 2018.

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