Safety and Efficacy of PC945 (Opelconazole) in Combination With Other Antifungal Therapy for the Treatment of Refractory Invasive Pulmonary Aspergillosis (OPERA-T Study)
NCT ID: NCT05238116
Last Updated: 2026-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
85 participants
INTERVENTIONAL
2022-06-14
2025-12-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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PC945
PC945 dose, administered via nebulizer, twice daily
PC945
Sterile aqueous liquid for Nebulization
Placebo
PC945-placebo administered via nebulizer, twice daily
Placebo
Sterile aqueous liquid for Nebulization
Interventions
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PC945
Sterile aqueous liquid for Nebulization
Placebo
Sterile aqueous liquid for Nebulization
Eligibility Criteria
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Inclusion Criteria
2. Participant's IPA has failed to respond to adequate antifungal therapy.
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Pulmocide Ltd
INDUSTRY
Responsible Party
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Locations
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Clinical Research Site
La Jolla, California, United States
Clinical Research Site
Los Angeles, California, United States
Clinical R Site
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
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
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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
Clinical Research Site
Montería, Departamento de Córdoba, Colombia
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Cali, Valle del Cauca Department, Colombia
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Paris, , France
Clinical Research Site
Strasbourg, , France
Clinical Research Site
Würzburg, Bavaria, Germany
Clinical Research Site
Frankfurt am Main, Hesse, Germany
Clinical Research Site
Athens, , Greece
Clinical Research Site
Thessaloniki, , Greece
Clinical Research Site
Bengaluru, Karnataka, India
Clinical Research Site 1
Pune, Maharashtra, India
Clinical Research Site 2
Pune, Maharashtra, India
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Hyderabad, Telangana, India
Clinical Research Site
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
Clinical Research Site
Siena, , Italy
Clinical Research Site
Daejeon, , South Korea
Clinical Research Site
Incheon, , South Korea
Clinical Research Site
Seoul, , South Korea
Clinical Research Site
Seoul, , South Korea
Clinical Research Site
Seoul, , South Korea
Clinical Research Site
Seoul, , South Korea
Clinical Research Site
Córdoba, Andalusia, Spain
Clinical Research Site
Barcelona, Catalonia, Spain
Clinical Research Site
Barcelona, Catalonia, Spain
Clinical Research Site
Majadahonda, Madrid, Spain
Clinical Research Site
Granada, , Spain
Clinical Research Site
Valencia, , Spain
Clinical Research Site
Tapei City, Tapai, Taiwan
Clinical Research Site
Kaohsiung City, , Taiwan
Clinical Research Site
New Taipei City, , Taiwan
Clinical Research Site
New Taipei City, , Taiwan
Clinical Research Site
Khlong Luang, Changwat Pathum Thani, Thailand
Clinical Research Site
Bangkok, , Thailand
Clinical Research Site
Bangkok, , Thailand
Clinical Research Site
Khon Kaen, , Thailand
Clinical Research Site
Harefield, Middlesex, United Kingdom
Clinical Research Site
London, , United Kingdom
Clinical Research Site
London, , United Kingdom
Clinical Research Site
London, , United Kingdom
Clinical Research Site
Manchester, , United Kingdom
Countries
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Other Identifiers
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2021-004554-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2024-511281-36
Identifier Type: REGISTRY
Identifier Source: secondary_id
PC_ASP_006
Identifier Type: -
Identifier Source: org_study_id
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