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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Refractory IPA

In brief

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

Key facts

Study ID

NCT05238116

Run by

Pulmocide Ltd

People needed

85

Starts

2022-06-14

Expected to finish

2025-12-29

Last updated by the study team

2026-04-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Clinical Research Site — Los Angeles, California, United States
• Clinical R Site — Los Angeles, California, United States
• Clinical Research Site — Sacramento, California, United States
• Clinical Research Site — Jacksonville, Florida, United States
• Clinical Research Site — Baltimore, Maryland, United States
• Clinical Research Site — Ann Arbor, Michigan, United States
• Clinical Research Site — Minneapolis, Minnesota, United States
• Clinical Research Site — St Louis, Missouri, United States
• Clinical Research Site — The Bronx, New York, United States
• Clinical Research Site — Philadelphia, Pennsylvania, United States
• Clinical Research Site — Pittsburgh, Pennsylvania, United States
• Clinical Research Site 1 — Houston, Texas, United States
• Clinical Research Site 2 — Houston, Texas, United States
• Clinical Research Site — Madison, Wisconsin, United States
• Clinical Research Site — Caba, Buenos Aires, Argentina
• Clinical Research Site — La Plata, Buenos Aires, Argentina
• Clinical Research Site — Caba, Buenos Aries, Argentina
• Clinical Research Site — Rosario, Santa Fe Province, Argentina
• Clinical Research Site — Mendoza, Argentina
• Clinical Research Site — Melbourne, Victoria, Australia
• Clinical Research Site — Parkville, Victoria, Australia
• Clinical Research Site — Graz, Styria, Austria
• Clinical Research Site — Vienna, Austria
• Clinical Research Site — Brussels, Belgium
• Clinical Research Site — La Jolla, California, United States

Full record on ClinicalTrials.gov

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