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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05238116




Registration number
NCT05238116
Ethics application status
Date submitted
3/02/2022
Date registered
14/02/2022
Date last updated
22/11/2024

Titles & IDs
Public title
Safety and Efficacy of PC945 (Opelconazole) in Combination With Other Antifungal Therapy for the Treatment of Refractory Invasive Pulmonary Aspergillosis (OPERA-T Study)
Scientific 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)
Secondary ID [1] 0 0
2021-004554-32
Secondary ID [2] 0 0
PC_ASP_006
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Refractory IPA 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PC945
Treatment: Drugs - Placebo

Experimental: PC945 - PC945 dose, administered via nebulizer, twice daily

Placebo comparator: Placebo - PC945-placebo administered via nebulizer, twice daily


Treatment: Drugs: PC945
Sterile aqueous liquid for Nebulization

Treatment: Drugs: Placebo
Sterile aqueous liquid for Nebulization
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Complete or Partial Overall Response
Timepoint [1] 0 0
up to 12 weeks (Day 84)
Secondary outcome [1] 0 0
Time to Complete or Partial Overall Clinical Response
Timepoint [1] 0 0
up to 12 weeks (Day 84)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/12/2025
Actual
Sample size
Target
123
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ParkvilleVIC
Recruitment hospital [1] 0 0
Clinical Research Site 106 - Melbourne
Recruitment hospital [2] 0 0
Clinical Research Site 107 - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
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Missouri
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United States of America
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New York
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United States of America
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Pennsylvania
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
State/province [13] 0 0
Washington
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United States of America
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Wisconsin
Country [15] 0 0
Argentina
State/province [15] 0 0
Buenos Aires
Country [16] 0 0
Argentina
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Mendoza
Country [17] 0 0
Argentina
State/province [17] 0 0
Santa Fe
Country [18] 0 0
Austria
State/province [18] 0 0
Graz
Country [19] 0 0
Austria
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Vienna
Country [20] 0 0
Belgium
State/province [20] 0 0
Brussels
Country [21] 0 0
Belgium
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Leuven
Country [22] 0 0
Brazil
State/province [22] 0 0
Curitiba
Country [23] 0 0
Brazil
State/province [23] 0 0
Santos
Country [24] 0 0
Brazil
State/province [24] 0 0
Rio Grande
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Brazil
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Santa Catarina
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Brazil
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São Paulo
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Canada
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Ontario
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Canada
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Hamilton
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Chile
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Santiago
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Chile
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Valparaíso
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Colombia
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Medellín
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Colombia
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Montería
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France
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Bordeaux
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France
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Paris
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France
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Strasbourg
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Germany
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Bavaria
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Germany
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Hesse
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Germany
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Cologne
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Greece
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Thessalonk
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Greece
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Athens
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India
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Karnataka
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India
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Maharashtra
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India
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Hyderabad
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India
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New Delhi
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India
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Pune
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Israel
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Haifa
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Israel
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Ramat Gan
Country [48] 0 0
Israel
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Safed
Country [49] 0 0
Italy
State/province [49] 0 0
Brescia
Country [50] 0 0
Italy
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Milan
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Italy
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Monza
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Italy
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Naples
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Italy
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Rome
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Italy
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Siena
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Korea, Republic of
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Daejeon
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Korea, Republic of
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Gyeonggi do
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seoul
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Spain
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Barcelona
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Spain
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Córdoba
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Spain
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Granada
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Spain
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Madrid
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Spain
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Santander
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Spain
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Valencia
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Taiwan
State/province [65] 0 0
New Tapai City
Country [66] 0 0
Taiwan
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Tapai
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Taiwan
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Kaohsiung
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Taiwan
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New Taipei City
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Taiwan
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Tainan
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Thailand
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Bangkok
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Thailand
State/province [71] 0 0
Khon Kaen
Country [72] 0 0
Thailand
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Pathum Thani
Country [73] 0 0
United Kingdom
State/province [73] 0 0
Cambridge
Country [74] 0 0
United Kingdom
State/province [74] 0 0
Harefield
Country [75] 0 0
United Kingdom
State/province [75] 0 0
London
Country [76] 0 0
United Kingdom
State/province [76] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pulmocide Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To assess the safety and efficacy of nebulized PC945 in combination with systemic antifungal therapy for the treatment of refractory IPA
Trial website
https://clinicaltrials.gov/study/NCT05238116
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Chief Medical Officer
Address 0 0
Country 0 0
Phone 0 0
+44 (0)203 763 9484
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05238116