Clinical trial NCT05238116: Safety and Efficacy of PC945 (Opelconazole) in Combination With Other Antifungal Therapy for the Treatment of Refractory Invasive Pulmonary Aspergillosis (OPERA-T Study)
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Refractory IPA
Keywords: Refractory IPA
invasive pulmonary aspergillosis
Lead sponsor: Pulmocide Ltd
Sponsor class: INDUSTRY
First posted: 2022-02-14
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Criteria:

1. 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.
2. Participant's IPA has failed to respond to adequate antifungal therapy.

Exclusion Criteria:

1. 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.
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

Primary outcomes:
measure: Number of Participants with Complete or Partial Overall Response
timeFrame: up to 12 weeks (Day 84)
Secondary outcomes:
measure: Time to Complete or Partial Overall Clinical Response
timeFrame: up to 12 weeks (Day 84)
Other outcomes:
Locations:
city: Duarte
country: United States
facility: Clinical Research Site 029
state: California
city: La Jolla
country: United States
facility: Clinical Research Site 009
state: California
city: Sacramento
country: United States
facility: Clinical Research Site 119
state: California
city: Jacksonville
country: United States
facility: Clinical Research Site 031
state: Florida
city: Indianapolis
country: United States
facility: Clinical Research Site 022
state: Indiana
city: Lexington
country: United States
facility: Clinical Research Site 023
state: Kentucky
city: Boston
country: United States
facility: Clinical Research Site 025
state: Massachusetts
city: Ann Arbor
country: United States
facility: Clinical Research Site 111
state: Michigan
city: Minneapolis
country: United States
facility: Clinical Research Site 095
state: Minnesota
city: Saint Louis
country: United States
facility: Clinical Research Site 010
state: Missouri
city: Bronx
country: United States
facility: Clinical Research Site 018
state: New York
city: Philadelphia
country: United States
facility: Clinical Research Site 002
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Clinical Research Site 001
state: Pennsylvania
city: Nashville
country: United States
facility: Clinical Research Site 030
state: Tennessee
city: Houston
country: United States
facility: Clinical Research Site 003
state: Texas
city: Houston
country: United States
facility: Clinical Research Site 028
state: Texas
city: Houston
country: United States
facility: Clinical Research Site 118
state: Texas
city: Seattle
country: United States
facility: Clinical Research Site 026
state: Washington
city: Madison
country: United States
facility: Clinical Research Site 032
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Clinical Research Site 034
city: Buenos Aires
country: Argentina
facility: Clinical Research Site 033
city: Buenos Aires
country: Argentina
facility: Clinical Research Site 035
city: Mendoza
country: Argentina
facility: Clinical Research Site 108
city: Santa Fe
country: Argentina
facility: Clinical Research Site 109
city: Melbourne
country: Australia
facility: Clinical Research Site 106
state: Parkville
city: Melbourne
country: Australia
facility: Clinical Research Site 107
state: Victoria
city: Graz
country: Austria
facility: Clinical Research Site 037
city: Vienna
country: Austria
facility: Clinical Research Site 036
city: Brussels
country: Belgium
facility: Clinical Research Site 098
city: Brussels
country: Belgium
facility: Clinical Research Site 038
city: Leuven
country: Belgium
facility: Clinical Research Site 039
city: Paraná
country: Brazil
facility: Clinical Research Site 044
state: Curitiba
city: Paranã
country: Brazil
facility: Clinical Research Site 040
state: Curitiba
city: São Paulo
country: Brazil
facility: Clinical Research Site 042
state: Santos
city: Rio Grande
country: Brazil
facility: Clinical Research Site 047
city: Rio Grande
country: Brazil
facility: Clinical Research Site 046
city: Rio Grande
country: Brazil
facility: Clinical Research Site 045
city: Santa Catarina
country: Brazil
facility: Clinical Research Site 043
city: São Paulo
country: Brazil
facility: Clinical Research Site 041
city: Toronto
country: Canada
facility: Clinical Research Site 008
state: Ontario
city: Toronto
country: Canada
facility: Clinical Research Site 110
state: Ontario
city: Hamilton
country: Canada
facility: Clinical Research Site 096
city: Santiago
country: Chile
facility: Clinical Research Site 049
city: Valparaíso
country: Chile
facility: Clinical Research Site 048
city: Medellín
country: Colombia
facility: Clinical Research Site 051
city: Montería
country: Colombia
facility: Clinical Research Site 050
city: Bordeaux
country: France
facility: Clinical Research Site 060
city: Paris
country: France
facility: Clinical Research Site 097
city: Strasbourg
country: France
facility: Clinical Research Site 059
city: Würzburg
country: Germany
facility: Clinical Research Site 071
state: Bavaria
city: Frankfurt
country: Germany
facility: Clinical Research Site 069
state: Hesse
city: Cologne
country: Germany
facility: Clinical Research Site 070
city: Exochí
country: Greece
facility: Clinical Research Site 073
state: Thessalonk
city: Athens
country: Greece
facility: Clinical Research Site 072
city: Karna
country: India
facility: Clinical Research Site104
state: Karnataka
city: Pune
country: India
facility: Clinical Research Site 099
state: Maharashtra
city: Hyderabad
country: India
facility: Clinical Research Site 103
city: Hyderabad
country: India
facility: Clinical Research Site 100
city: New Delhi
country: India
facility: Clinical Research Site 101
city: Pune
country: India
facility: Clinical Research Site 102
city: Haifa
country: Israel
facility: Clinical Research Site 076
city: Ramat Gan
country: Israel
facility: Clinical Research Site 075
city: Safed
country: Israel
facility: Clinical Research Site 074
city: Brescia
country: Italy
facility: Clinical Research Site 081
city: Milan
country: Italy
facility: Clinical Research Site 080
city: Monza
country: Italy
facility: Clinical Research Site 077
city: Naples
country: Italy
facility: Clinical Research Site 079
city: Rome
country: Italy
facility: Clinical Research Site 078
city: Siena
country: Italy
facility: Clinical Research Site 082
city: Daejeon
country: Korea, Republic of
facility: Clinical Research Site 086
city: Gyeonggi do
country: Korea, Republic of
facility: Clinical Research Site 083
city: Incheon
country: Korea, Republic of
facility: Clinical Research Site 084
city: Seoul
country: Korea, Republic of
facility: Clinical Research Site 089
city: Seoul
country: Korea, Republic of
facility: Clinical Research Site 085
city: Seoul
country: Korea, Republic of
facility: Clinical Research Site 088
city: Seoul
country: Korea, Republic of
facility: Clinical Research Site 087
city: Barcelona
country: Spain
facility: Clinical Research Site 054
city: Barcelona
country: Spain
facility: Clinical Research Site 057
city: Córdoba
country: Spain
facility: Clinical Research Site 052
city: Granada
country: Spain
facility: Clinical Research Site 053
city: Madrid
country: Spain
facility: Clinical Research Site 058
city: Santander
country: Spain
facility: Clinical Research Site 056
city: Valencia
country: Spain
facility: Clinical Research Site 055
city: Taipei
country: Taiwan
facility: Clinical Research Site 094
state: New Tapai City
city: Tapei City
country: Taiwan
facility: Clinical Research Site 090
state: Tapai
city: Kaohsiung
country: Taiwan
facility: Clinical Research Site 092
city: New Taipei City
country: Taiwan
facility: Clinical Research Site 091
city: Tainan
country: Taiwan
facility: Clinical Research Site 093
city: Bangkok
country: Thailand
facility: Clinical Research Site 113
city: Bangkok
country: Thailand
facility: Clinical Research Site 112
city: Khon Kaen
country: Thailand
facility: Clinical Research Site 114
city: Pathum Thani
country: Thailand
facility: Clinical Research Site 115
city: Cambridge
country: United Kingdom
facility: Clinical Research Site 065
city: Harefield
country: United Kingdom
facility: Clinical Research Site 066
city: London
country: United Kingdom
facility: Clinical Research Site 063
city: London
country: United Kingdom
facility: Clinical Research Site 062
city: London
country: United Kingdom
facility: Clinical Research Site 064
city: Manchester
country: United Kingdom
facility: Clinical Research Site 067
Study officials:
References: