Safety and Efficacy of PC945 (Opelconazole) in Combination With Other Antifungal Therapy for the Treatment of Refractory Invasive Pulmonary Aspergillosis (OPERA-T Study)
- Registration Number
- NCT05238116
- Lead Sponsor
- Pulmocide Ltd
- Brief Summary
To assess the safety and efficacy of nebulized PC945 in combination with systemic antifungal therapy for the treatment of refractory IPA
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 123
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo PC945-placebo administered via nebulizer, twice daily PC945 PC945 PC945 dose, administered via nebulizer, twice daily
- Primary Outcome Measures
Name Time Method Number of Participants with Complete or Partial Overall Response up to 12 weeks (Day 84)
- Secondary Outcome Measures
Name Time Method Time to Complete or Partial Overall Clinical Response up to 12 weeks (Day 84)
Trial Locations
- Locations (98)
Clinical Research Site 097
🇫🇷Paris, France
Clinical Research Site 059
🇫🇷Strasbourg, France
Clinical Research Site 071
🇩🇪Würzburg, Bavaria, Germany
Clinical Research Site 069
🇩🇪Frankfurt, Hesse, Germany
Clinical Research Site 070
🇩🇪Cologne, Germany
Clinical Research Site 073
🇬🇷Exochí, Thessalonk, Greece
Clinical Research Site 072
🇬🇷Athens, Greece
Clinical Research Site 029
🇺🇸Duarte, California, United States
Clinical Research Site 009
🇺🇸La Jolla, California, United States
Clinical Research Site 119
🇺🇸Sacramento, California, United States
Clinical Research Site 031
🇺🇸Jacksonville, Florida, United States
Clinical Research Site 022
🇺🇸Indianapolis, Indiana, United States
Clinical Research Site 023
🇺🇸Lexington, Kentucky, United States
Clinical Research Site 010
🇺🇸Saint Louis, Missouri, United States
Clinical Research Site 002
🇺🇸Philadelphia, Pennsylvania, United States
Clinical Research Site 098
🇧🇪Brussels, Belgium
Clinical Research Site 039
🇧🇪Leuven, Belgium
Clinical Research Site 042
🇧🇷São Paulo, Santos, Brazil
Clinical Research Site 025
🇺🇸Boston, Massachusetts, United States
Clinical Research Site 111
🇺🇸Ann Arbor, Michigan, United States
Clinical Research Site 095
🇺🇸Minneapolis, Minnesota, United States
Clinical Research Site 001
🇺🇸Pittsburgh, Pennsylvania, United States
Clinical Research Site 026
🇺🇸Seattle, Washington, United States
Clinical Research Site 033
🇦🇷Buenos Aires, Argentina
Clinical Research Site 109
🇦🇷Santa Fe, Argentina
Clinical Research Site 045
🇧🇷Rio Grande, Brazil
Clinical Research Site 110
🇨🇦Toronto, Ontario, Canada
Clinical Research Site 096
🇨🇦Hamilton, Canada
Clinical Research Site 018
🇺🇸Bronx, New York, United States
Clinical Research Site 003
🇺🇸Houston, Texas, United States
Clinical Research Site 032
🇺🇸Madison, Wisconsin, United States
Clinical Research Site 035
🇦🇷Buenos Aires, Argentina
Clinical Research Site 037
🇦🇹Graz, Austria
Clinical Research Site 044
🇧🇷Paraná, Curitiba, Brazil
Clinical Research Site 046
🇧🇷Rio Grande, Brazil
Clinical Research Site 043
🇧🇷Santa Catarina, Brazil
Clinical Research Site 049
🇨🇱Santiago, Chile
Clinical Research Site 030
🇺🇸Nashville, Tennessee, United States
Clinical Research Site 028
🇺🇸Houston, Texas, United States
Clinical Research Site 118
🇺🇸Houston, Texas, United States
Clinical Research Site 108
🇦🇷Mendoza, Argentina
Clinical Research Site 106
🇦🇺Melbourne, Parkville, Australia
Clinical Research Site 107
🇦🇺Melbourne, Victoria, Australia
Clinical Research Site 036
🇦🇹Vienna, Austria
Clinical Research Site 047
🇧🇷Rio Grande, Brazil
Clinical Research Site 041
🇧🇷São Paulo, Brazil
Clinical Research Site 034
🇦🇷Buenos Aires, Argentina
Clinical Research Site 038
🇧🇪Brussels, Belgium
Clinical Research Site 040
🇧🇷Paranã, Curitiba, Brazil
Clinical Research Site 008
🇨🇦Toronto, Ontario, Canada
Clinical Research Site 048
🇨🇱Valparaíso, Chile
Clinical Research Site 051
🇨🇴Medellín, Colombia
Clinical Research Site 050
🇨🇴Montería, Colombia
Clinical Research Site 060
🇫🇷Bordeaux, France
Clinical Research Site104
🇮🇳Karna, Karnataka, India
Clinical Research Site 099
🇮🇳Pune, Maharashtra, India
Clinical Research Site 103
🇮🇳Hyderabad, India
Clinical Research Site 100
🇮🇳Hyderabad, India
Clinical Research Site 101
🇮🇳New Delhi, India
Clinical Research Site 102
🇮🇳Pune, India
Clinical Research Site 076
🇮🇱Haifa, Israel
Clinical Research Site 075
🇮🇱Ramat Gan, Israel
Clinical Research Site 074
🇮🇱Safed, Israel
Clinical Research Site 081
🇮🇹Brescia, Italy
Clinical Research Site 080
🇮🇹Milan, Italy
Clinical Research Site 077
🇮🇹Monza, Italy
Clinical Research Site 079
🇮🇹Naples, Italy
Clinical Research Site 078
🇮🇹Rome, Italy
Clinical Research Site 082
🇮🇹Siena, Italy
Clinical Research Site 086
🇰🇷Daejeon, Korea, Republic of
Clinical Research Site 083
🇰🇷Gyeonggi do, Korea, Republic of
Clinical Research Site 084
🇰🇷Incheon, Korea, Republic of
Clinical Research Site 089
🇰🇷Seoul, Korea, Republic of
Clinical Research Site 085
🇰🇷Seoul, Korea, Republic of
Clinical Research Site 088
🇰🇷Seoul, Korea, Republic of
Clinical Research Site 087
🇰🇷Seoul, Korea, Republic of
Clinical Research Site 054
🇪🇸Barcelona, Spain
Clinical Research Site 057
🇪🇸Barcelona, Spain
Clinical Research Site 052
🇪🇸Córdoba, Spain
Clinical Research Site 053
🇪🇸Granada, Spain
Clinical Research Site 058
🇪🇸Madrid, Spain
Clinical Research Site 056
🇪🇸Santander, Spain
Clinical Research Site 055
🇪🇸Valencia, Spain
Clinical Research Site 094
🇨🇳Taipei, New Tapai City, Taiwan
Clinical Research Site 090
🇨🇳Tapei City, Tapai, Taiwan
Clinical Research Site 092
🇨🇳Kaohsiung, Taiwan
Clinical Research Site 091
🇨🇳New Taipei City, Taiwan
Clinical Research Site 093
🇨🇳Tainan, Taiwan
Clinical Research Site 113
🇹🇭Bangkok, Thailand
Clinical Research Site 112
🇹🇭Bangkok, Thailand
Clinical Research Site 114
🇹🇭Khon Kaen, Thailand
Clinical Research Site 115
🇹🇭Pathum Thani, Thailand
Clinical Research Site 065
🇬🇧Cambridge, United Kingdom
Clinical Research Site 066
🇬🇧Harefield, United Kingdom
Clinical Research Site 063
🇬🇧London, United Kingdom
Clinical Research Site 062
🇬🇧London, United Kingdom
Clinical Research Site 064
🇬🇧London, United Kingdom
Clinical Research Site 067
🇬🇧Manchester, United Kingdom