Safety and Efficacy of PC945 (Opelconazole) in Combination With Other Antifungal Therapy for the Treatment of Refractory Invasive Pulmonary Aspergillosis (OPERA-T Study)

Description

To assess the safety and efficacy of nebulized PC945 in combination with systemic antifungal therapy for the treatment of refractory IPA

Conditions

Refractory IPA

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Study Overview

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Study Details

Study overview

To assess the safety and efficacy of nebulized PC945 in combination with systemic antifungal therapy for the treatment of refractory IPA

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 (OPERA-T Study)

Safety and Efficacy of PC945 (Opelconazole) in Combination With Other Antifungal Therapy for the Treatment of Refractory Invasive Pulmonary Aspergillosis (OPERA-T Study)

Condition
Refractory IPA
Intervention / Treatment

-

Contacts and Locations

Duarte

Clinical Research Site 029, Duarte, California, United States, 91010

La Jolla

Clinical Research Site 009, La Jolla, California, United States, 1801492037

Sacramento

Clinical Research Site 119, Sacramento, California, United States, 95817

Jacksonville

Clinical Research Site 031, Jacksonville, Florida, United States, 32224

Indianapolis

Clinical Research Site 022, Indianapolis, Indiana, United States, 46202

Lexington

Clinical Research Site 023, Lexington, Kentucky, United States, 40506

Boston

Clinical Research Site 025, Boston, Massachusetts, United States, 02115

Ann Arbor

Clinical Research Site 111, Ann Arbor, Michigan, United States, 48109

Minneapolis

Clinical Research Site 095, Minneapolis, Minnesota, United States, 55455

Saint Louis

Clinical Research Site 010, Saint Louis, Missouri, United States, 63110

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 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.
  • 1. Participant with a known or suspected concomitant medical condition or post-surgery complication that, in the opinion of the Investigator, may jeopardize adherence to the protocol requirements or impede the accurate measurement of efficacy or may be an unacceptable additional risk to the Participant should he/she participate in the study.
  • 2. Participant who has previously received PC945.
  • 3. Participant with a known history of allergy, hypersensitivity, or any previous serious reaction to any component of the PC945 or placebo formulations.
  • 4. Participant who has recently received, is receiving or due to receive at any time during the study, an investigational medicinal agent that does not have any regulatory approved indications. Subjects who are participating in any other trials e.g., Observational, diagnostic or using medications with an approved indication may be allowed to participate after consultation with the sponsor on an individual basis

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Pulmocide Ltd,

Study Record Dates

2025-12-30