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Safety and Efficacy of PC945 (Opelconazole) in Combination With Other Antifungal Therapy for the Treatment of Refractory Invasive Pulmonary Aspergillosis (OPERA-T Study)
Sponsor: Pulmocide Ltd
Summary
To assess the safety and efficacy of nebulized PC945 in combination with systemic antifungal therapy for the treatment of refractory IPA
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
85
Start Date
2022-06-14
Completion Date
2025-12-29
Last Updated
2026-04-30
Healthy Volunteers
No
Conditions
Interventions
PC945
Sterile aqueous liquid for Nebulization
Placebo
Sterile aqueous liquid for Nebulization
Locations (83)
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La Jolla, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Sacramento, California, United States
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Jacksonville, Florida, United States
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Baltimore, Maryland, United States
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Ann Arbor, Michigan, United States
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Minneapolis, Minnesota, United States
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St Louis, Missouri, United States
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The Bronx, New York, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Madison, Wisconsin, United States
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Caba, Buenos Aires, Argentina
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La Plata, Buenos Aires, Argentina
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Caba, Buenos Aries, Argentina
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Rosario, Santa Fe Province, Argentina
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Mendoza, Argentina
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Melbourne, Victoria, Australia
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Parkville, Victoria, Australia
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Graz, Styria, Austria
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Vienna, Austria
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Brussels, Belgium
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Brussels, Belgium
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Leuven, Belgium
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Curitiba, Paraná, Brazil
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Curitiba, Paraná, Brazil
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Passo Fundo, Rio Grande do Sul, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Santa Maria, Rio Grande do Sul, Brazil
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Jaú, São Paulo, Brazil
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Santos, São Paulo, Brazil
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Hamilton, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Valparaíso, Chile
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Montería, Departamento de Córdoba, Colombia
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Cali, Valle del Cauca Department, Colombia
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Paris, France
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Strasbourg, France
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Würzburg, Bavaria, Germany
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Frankfurt am Main, Hesse, Germany
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Athens, Greece
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Thessaloniki, Greece
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Bengaluru, Karnataka, India
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Pune, Maharashtra, India
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Pune, Maharashtra, India
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Hyderabad, Telangana, India
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New Delhi, India
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Haifa, Israel
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Ramat Gan, Israel
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Brescia, Lombardy, Italy
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Monza, Italy
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Naples, Italy
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Rome, Italy
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Siena, Italy
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Daejeon, South Korea
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Incheon, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Córdoba, Andalusia, Spain
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Barcelona, Catalonia, Spain
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Barcelona, Catalonia, Spain
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Majadahonda, Madrid, Spain
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Granada, Spain
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Valencia, Spain
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Tapei City, Tapai, Taiwan
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Kaohsiung City, Taiwan
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New Taipei City, Taiwan
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New Taipei City, Taiwan
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Khlong Luang, Changwat Pathum Thani, Thailand
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Bangkok, Thailand
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Bangkok, Thailand
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Khon Kaen, Thailand
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Harefield, Middlesex, United Kingdom
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London, United Kingdom
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London, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom