Safety and Efficacy of PC945 (Opelconazole) in Combination With Other Antifungal Therapy for the Treatment of Refractory Invasive Pulmonary Aspergillosis (OPERA-T Study)

April 10, 2026 updated by: Pulmocide Ltd

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)

To assess the safety and efficacy of nebulized PC945 in combination with systemic antifungal therapy for the treatment of refractory IPA

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
85

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Senior Medical Director of Clinical Development
  • Phone Number: is +44 (0) 203 763 9484
  • Email: admin@pulmocide.com

Study Locations

  • Argentina
      • Mendoza, Argentina, M5500
        • Clinical Research Site
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1199ABB
        • Clinical Research Site
      • La Plata, Buenos Aires, Argentina, B1900
        • Clinical Research Site
    • Buenos Aries
      • Caba, Buenos Aries, Argentina, C1118AAT
        • Clinical Research Site
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000CVB
        • Clinical Research Site
  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Clinical Research Site
      • Parkville, Victoria, Australia, 3050
        • Clinical Research Site
  • Austria
      • Vienna, Austria, 1090
        • Clinical Research Site
    • Styria
      • Graz, Styria, Austria, 8036
        • Clinical Research Site
  • Belgium
      • Brussels, Belgium, B-1070
        • Clinical Research Site
      • Brussels, Belgium, B-1200
        • Clinical Research Site
      • Leuven, Belgium, B-3000
        • Clinical Research Site
  • Brazil
    • Paraná
      • Curitiba, Paraná, Brazil, 80060-900
        • Clinical Research Site
      • Curitiba, Paraná, Brazil, 81520060
        • Clinical Research Site
    • Rio Grande do Sul
      • Passo Fundo, Rio Grande do Sul, Brazil, 99010260
        • Clinical Research Site
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035903
        • Clinical Research Site
      • Santa Maria, Rio Grande do Sul, Brazil, 97105900
        • Clinical Research Site
    • São Paulo
      • Jaú, São Paulo, Brazil, 17210-080
        • Clinical Research Site
      • Santos, São Paulo, Brazil, 11075101
        • Clinical Research Site
  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8V 1C3
        • Clinical Research Site
      • Toronto, Ontario, Canada, M5G 2C4
        • Clinical Research Site
      • Toronto, Ontario, Canada, M6G2N2
        • Clinical Research Site
  • Chile
      • Valparaíso, Chile, 2570017
        • Clinical Research Site
  • Colombia
    • Departamento de Córdoba
      • Montería, Departamento de Córdoba, Colombia, 230002
        • Clinical Research Site
    • Valle del Cauca Department
      • Cali, Valle del Cauca Department, Colombia, 760032
        • Clinical Research Site
  • France
      • Paris, France, 75015
        • Clinical Research Site
      • Strasbourg, France, 67091
        • Clinical Research Site
  • Germany
    • Bavaria
      • Würzburg, Bavaria, Germany, 97080
        • Clinical Research Site
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60590
        • Clinical Research Site
  • Greece
      • Athens, Greece, 11527
        • Clinical Research Site
      • Thessaloniki, Greece, 57010
        • Clinical Research Site
  • India
      • New Delhi, India, 110017
        • Clinical Research Site
    • Karnataka
      • Bengaluru, Karnataka, India, 560034
        • Clinical Research Site
    • Maharashtra
      • Pune, Maharashtra, India, 411004
        • Clinical Research Site 1
      • Pune, Maharashtra, India, 411004
        • Clinical Research Site 2
    • Telangana
      • Hyderabad, Telangana, India, 500082
        • Clinical Research Site
  • Israel
      • Haifa, Israel, 3109601
        • Clinical Research Site
      • Ramat Gan, Israel, 5266202
        • Clinical Research Site
  • Italy
      • Monza, Italy, 20900
        • Clinical Research Site
      • Naples, Italy, 80131
        • Clinical Research Site
      • Rome, Italy, 00168
        • Clinical Research Site
      • Siena, Italy, 53100
        • Clinical Research Site
    • Lombardy
      • Brescia, Lombardy, Italy, 25123
        • Clinical Research Site
  • South Korea
      • Daejeon, South Korea, 35015
        • Clinical Research Site
      • Incheon, South Korea, 21565
        • Clinical Research Site
      • Seoul, South Korea, 02841
        • Clinical Research Site
      • Seoul, South Korea, 06273
        • Clinical Research Site
      • Seoul, South Korea, 06351
        • Clinical Research Site
      • Seoul, South Korea, 06591
        • Clinical Research Site
  • Spain
      • Granada, Spain, 18014
        • Clinical Research Site
      • Valencia, Spain, 46026
        • Clinical Research Site
    • Andalusia
      • Córdoba, Andalusia, Spain, 14004
        • Clinical Research Site
    • Catalonia
      • Barcelona, Catalonia, Spain, 08035
        • Clinical Research Site
      • Barcelona, Catalonia, Spain, 08036
        • Clinical Research Site
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Clinical Research Site
  • Taiwan
      • Kaohsiung City, Taiwan, 807377
        • Clinical Research Site
      • New Taipei City, Taiwan, 220
        • Clinical Research Site
      • New Taipei City, Taiwan, 23561
        • Clinical Research Site
    • Tapai
      • Tapei City, Tapai, Taiwan, 100225
        • Clinical Research Site
  • Thailand
      • Bangkok, Thailand, 10400
        • Clinical Research Site
      • Bangkok, Thailand, 10700
        • Clinical Research Site
      • Khon Kaen, Thailand, 40002
        • Clinical Research Site
    • Changwat Pathum Thani
      • Khlong Luang, Changwat Pathum Thani, Thailand, 12120
        • Clinical Research Site
  • United Kingdom
      • London, United Kingdom, SE5 9RS
        • Clinical Research Site
      • London, United Kingdom, SW17 0QT
        • Clinical Research Site
      • London, United Kingdom, W12 0HS
        • Clinical Research Site
      • Manchester, United Kingdom, M23 9LT
        • Clinical Research Site
    • Middlesex
      • Harefield, Middlesex, United Kingdom, UB9 6JH
        • Clinical Research Site
  • United States
    • California
      • La Jolla, California, United States, 92037
        • Clinical Research Site
      • Los Angeles, California, United States, 90048
        • Clinical Research Site
      • Los Angeles, California, United States, 90095
        • Clinical R Site
      • Sacramento, California, United States, 95817
        • Clinical Research Site
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Clinical Research Site
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Clinical Research Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Clinical Research Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Clinical Research Site
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Clinical Research Site
    • New York
      • The Bronx, New York, United States, 10467
        • Clinical Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19014
        • Clinical Research Site
      • Pittsburgh, Pennsylvania, United States, 15213
        • Clinical Research Site
    • Texas
      • Houston, Texas, United States, 77030
        • Clinical Research Site 1
      • Houston, Texas, United States, 77030
        • Clinical Research Site 2
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Clinical Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PC945
PC945 dose, administered via nebulizer, twice daily
Drug: PC945
Sterile aqueous liquid for Nebulization
Placebo Comparator: Placebo
PC945-placebo administered via nebulizer, twice daily
Drug: Placebo
Sterile aqueous liquid for Nebulization

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants Alive With Favorable Overall Response as Assessed by the Data Review Committee (DRC)
Time Frame: At Day 84
Favorable overall response was defined as being alive and having a complete or partial overall response at Day 84 as determined by the DRC. Complete or partial response was defined by the Classification and Criteria for the Assessment of Overall Response, adapted from Segal, 2008.
At Day 84

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Favorable Overall Response
Time Frame: up to 12 weeks (Day 84)
Favorable overall response was defined as having a complete or partial overall response at at any time during the 12-week treatment where the survival component was not included as a part of the response definition. Complete or partial response was defined by the Classification and Criteria for the Assessment of Overall Response, adapted from Segal, 2008.
up to 12 weeks (Day 84)
Time to Favorable Overall Response
Time Frame: up to Day 42 or Day 84
Time to favorable overall response was defined as the time from randomization to the first favorable overall response (complete or partial response). Complete or partial response was defined by the Classification and Criteria for the Assessment of Overall Response, adapted from Segal, 2008.
up to Day 42 or Day 84
All-cause Mortality
Time Frame: From First Dose of Study Treatment up to Week 16 (Safety Follow-up)
All-cause mortality was defined as death from any cause.
From First Dose of Study Treatment up to Week 16 (Safety Follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pulmocide Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 14, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 29, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 29, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 3, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 14, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PC_ASP_006
  • 2021-004554-32 (EudraCT Number)
  • 2024-511281-36 (Registry Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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