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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03561415




Registration number
NCT03561415
Ethics application status
Date submitted
9/05/2018
Date registered
19/06/2018
Date last updated
19/06/2018

Titles & IDs
Public title
Universal Prophylaxis Versus Pre-emptive Therapy With Posaconazole Post-Lung Transplant
Scientific title
Universal Posaconazole Prophylaxis Versus Pre-emptive Posaconazole Therapy for Fungal Infection Management Post-lung Transplantation
Secondary ID [1] 0 0
204/17
Universal Trial Number (UTN)
Trial acronym
UPPRITE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fungal Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Universal Posaconazole Prophylaxis
Other interventions - Pre-emptive Posaconazole Therapy

Experimental: Universal posaconazole prophylaxis - Universal 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.

Experimental: Pre-emptive posaconazole therapy - Pre-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.


Other interventions: Universal Posaconazole Prophylaxis
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.

Other interventions: Pre-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 for 3 months.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Composite of: screened that are eligible, eligible that are enrolled, lost to follow-up or are withdrawn from the trial, receive their allocated treatment throughout the trial participation and have missing data during trial data collection.
Timepoint [1] 0 0
2 years and 3 months
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
2 years and 3 months
Secondary outcome [2] 0 0
Fungal pneumonia, fungal tracheobronchitis, or bronchial anastomotic fungal infection rates
Timepoint [2] 0 0
2 years and 3 months
Secondary outcome [3] 0 0
CLAD rates
Timepoint [3] 0 0
2 years and 3 months
Secondary outcome [4] 0 0
All-cause mortality rates
Timepoint [4] 0 0
2 years and 3 months
Secondary outcome [5] 0 0
Fungal pneumonia, fungal tracheobronchitis, or bronchial anastomotic fungal infection-related mortality rates
Timepoint [5] 0 0
2 years and 3 months
Secondary outcome [6] 0 0
CLAD-related mortality rates
Timepoint [6] 0 0
2 years and 3 months
Secondary outcome [7] 0 0
Time to development of fungal pneumonia, fungal tracheobronchitis, bronchial anastomotic fungal infection
Timepoint [7] 0 0
2 years and 3 months
Secondary outcome [8] 0 0
Time to diagnosis of CLAD
Timepoint [8] 0 0
2 years and 3 months
Secondary outcome [9] 0 0
Costs associated with allocated arm including number of hospital admissions
Timepoint [9] 0 0
2 years and 3 months
Secondary outcome [10] 0 0
Quality of life (QoL) using Short Form Survey (sf-36) to measure patient health
Timepoint [10] 0 0
2 years and 3 months
Secondary outcome [11] 0 0
Acute rejection rates
Timepoint [11] 0 0
2 years and 3 months
Secondary outcome [12] 0 0
Posaconazole adverse drug reaction (ADR) rates
Timepoint [12] 0 0
2 years and 3 months
Secondary outcome [13] 0 0
Proportion of patients who discontinue posaconazole because of an ADR
Timepoint [13] 0 0
2 years and 3 months
Secondary outcome [14] 0 0
Total duration on posaconazole
Timepoint [14] 0 0
2 years and 3 months

Eligibility
Key inclusion criteria
1. Male and female aged = 18 years

2. Undergoing bilateral sequential lung transplant (BSLT) or heart-lung transplant (HLT)
including re-do transplant

3. Able to give written informed consent

4. Able to understand and comply with all trial requirements
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Less than 18 years of age

2. Scheduled to undergo a single-lung transplant (known risk factor for IFD)

3. Scheduled to undergo multi-organ transplant, other than HLT

4. Recipients who will not be followed up for 1-year post-transplant at one of the trial
sites

5. Isolation of a mould within the 12 months prior to screening

6. Evidence of a mycetoma within the 12 months prior to screening

7. Proven or probable IFD within the 12 months prior to screening

8. 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)

9. Any other severe condition which in the site investigator's judgement may interfere
with the trial evaluations or severely affect the patients safety

10. Previous inclusion in the trial

11. Currently enrolled in an antifungal or other investigational drug trial

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
2/07/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2020
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
St. Vincent's Hospital - Sydney
Recruitment hospital [2] 0 0
The Prince Charles Hospital - Brisbane
Recruitment hospital [3] 0 0
Alfred Health - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment postcode(s) [2] 0 0
4032 - Brisbane
Recruitment postcode(s) [3] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Bayside Health
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Merck Sharp & Dohme LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03561415
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Orla Morrissey
Address 0 0
The Alfred
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Orla Morrissey
Address 0 0
Country 0 0
Phone 0 0
+61 3 90762631
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03561415