Nebulized PC945 and Systemic Antifungal Therapy in Refractory Invasive Pulmonary Aspergillosis

What is the Purpose of this Study?

This study focuses on people who have been diagnosed with invasive pulmonary aspergillosis (IPA, a lung infection caused by a common fungus found in the environment called aspergillus) and who are not responding well to their current antifungal therapy. The purpose of the study is to evaluate the safety and effectiveness of an investigational inhaled antifungal drug called opelconazole (PC945 nebulizer suspension) when given in combination with standard-of-care antifungal therapy. The study will also assess how opelconazole is processed in the body including how it is distributed, transformed, and removed, by measuring the levels of opelconazole in the blood and lungs; this is called pharmacokinetics. Opelconazole is designed as an inhaled treatment. Participants will be randomly assigned to 1 of 2 treatment groups: the opelconazole plus standard-of-care antifungal therapy group, or the placebo (inactive substance) plus standard-of-care antifungal therapy group.


Eligibility

  • 1. Participant has proven or probable IPA according to the modified 2019 European Organization for Research and Treatment of Cancer/ Mycoses Study Group Education and Research Consortium (EORTC/MSGERC) consensus definitions or according to the 2010 International Society for Heart and Lung Transplantation (ISHLT) consensus statements for the definitions of infections in cardiothoracic transplant recipients.
  • 2. Participant's IPA has failed to respond to adequate antifungal therapy.
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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

A double-blind, randomized, placebo-controlled study to assess the safety and efficacy of nebulized PC945 when added to systemic antifungal therapy for the treatment of refractory invasive pulmonary aspergillosis

Study Details
Disease Type/Condition

Other

Principal Investigator

Rampolla, Reinaldo

Age Group

Adult

Phase

III

IRB Number

STUDY00003938

ClinicalTrials.gov ID

NCT05238116

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Other

Principal Investigator

Rampolla, Reinaldo

Age Group

Adult

Phase

III

IRB Number

PC-ASP-006

ClinicalTrials.gov ID

NCT05238116

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org