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

NCT03561415 | Unknown Phase 2 DMC

• 1 other identifier: 204/17
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 3

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.

Conditions

Fungal Infection

Keywords

Lung transplant, prophylaxis, pre-emptive

Outcome Measures

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• Composite of: screened that are eligible, eligible that are enrolled, lost to follow-up or are withdrawn from the trial, receive their allocated treatment throughout the trial participation and have missing data during trial data collection.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

  2 years and 3 months

Secondary Outcomes (14)

• 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

  2 years and 3 months

• Fungal pneumonia, fungal tracheobronchitis, or bronchial anastomotic fungal infection rates

  2 years and 3 months

• CLAD rates

  2 years and 3 months

• All-cause mortality rates

  2 years and 3 months

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

  2 years and 3 months

Study Arms (2)

Universal posaconazole prophylaxis

EXPERIMENTAL

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.

Other: Universal Posaconazole Prophylaxis

Pre-emptive posaconazole therapy

EXPERIMENTAL

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: Pre-emptive Posaconazole Therapy

Interventions

Universal Posaconazole Prophylaxis OTHER

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.

Universal posaconazole prophylaxis

Pre-emptive Posaconazole Therapy OTHER

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.

Pre-emptive posaconazole therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• Currently enrolled in an antifungal or other investigational drug trial

Sponsors & Collaborators

• Bayside Health: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (3)

St. Vincent's Hospital

Sydney, New South Wales, 2010, Australia

Location

The Prince Charles Hospital

Brisbane, Queensland, 4032, Australia

Location

Alfred Health

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Mycoses

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Officials

• Orla Morrissey

  The Alfred

  STUDY CHAIR

Central Study Contacts

Orla Morrissey

CONTACT

+61 3 90762631; o.morrissey@alfred.org.au

Greg Snell

CONTACT

+61 90762000; g.snell@alfred.org.au

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2018
• First Posted: June 19, 2018
• Study Start: July 2, 2018
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: June 19, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3)