Safety and Efficacy of PC945 in Combination With Other Antifungal Therapy for the Treatment of Refractory Invasive Pulmonary Aspergillosis

Brief Summary
To assess the safety and efficacy of nebulized PC945 in combination with systemic antifungal therapy for the treatment of refractory IPA
Brief Title
Safety and Efficacy of PC945 (Opelconazole) in Combination With Other Antifungal Therapy for the Treatment of Refractory Invasive Pulmonary Aspergillosis (OPERA-T Study)
Central Contacts
Central Contact Role
Contact
Central Contact Phone
+44 (0)203 763 9484
Central Contact Email
admin@pulmocide.com
Central Contact Role
Contact
Central Contact Phone
is +44 (0) 203 763 9484
Central Contact Email
admin@pulmocide.com
Completion Date
Completion Date Type
Estimated
Conditions
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
Inclusion 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.

Gender
All
Gender Based
false
Keywords
Refractory IPA
invasive pulmonary aspergillosis
Healthy Volunteers
No
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT05238116
Org Class
Industry
Org Full Name
Pulmocide Ltd
Org Study Id
PC_ASP_006
Overall Status
Recruiting
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Estimated
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)
Primary Outcomes
Outcome Measure
Number of Participants with Complete or Partial Overall Response
Outcome Time Frame
up to 12 weeks (Day 84)
Secondary Ids
Secondary Id
2021-004554-32
Secondary Id
2024-511281-36
Secondary Outcomes
Outcome Time Frame
up to 12 weeks (Day 84)
Outcome Measure
Time to Complete or Partial Overall Clinical Response
Start Date
Start Date Type
Actual
Status Verified Date
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Ali Mansour
Investigator Email
amansour@montefiore.org