Status:
RECRUITING
Safety and Efficacy of PC945 (Opelconazole) in Combination With Other Antifungal Therapy for the Treatment of Refractory Invasive Pulmonary Aspergillosis (OPERA-T Study)
Lead Sponsor:
Pulmocide Ltd
Conditions:
Refractory IPA
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To assess the safety and efficacy of nebulized PC945 in combination with systemic antifungal therapy for the treatment of refractory IPA
Eligibility Criteria
Inclusion
- 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.
- Participant's IPA has failed to respond to adequate antifungal therapy.
Exclusion
- 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.
- Participant who has previously received PC945.
- Participant with a known history of allergy, hypersensitivity, or any previous serious reaction to any component of the PC945 or placebo formulations.
- 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
Key Trial Info
Start Date :
June 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT05238116
Start Date
June 14 2022
End Date
April 30 2026
Last Update
December 17 2025
Active Locations (98)
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1
Clinical Research Site
Duarte, California, United States, 91010
2
Clinical Research Site
La Jolla, California, United States, 92037
3
Clinical Research Site
Los Angeles, California, United States, 90048
4
Clinical R Site
Los Angeles, California, United States, 90095