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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05238116
Recruitment Status : Recruiting
First Posted : February 14, 2022
Last Update Posted : May 8, 2023
Sponsor:
Information provided by (Responsible Party):
Pulmocide Ltd

Study Description
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Brief Summary:
To assess the efficacy of nebulized PC945 in combination with systemic antifungal therapy for the treatment of refractory IPA

Condition or disease Intervention/treatment Phase
Refractory IPA Drug: PC945 Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double Blind
Primary Purpose: Treatment
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
Actual Study Start Date : June 14, 2022
Estimated Primary Completion Date : October 31, 2023
Estimated Study Completion Date : November 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aspergillosis

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants with Complete or Partial Overall Response [ Time Frame: up to 12 weeks ]

Secondary Outcome Measures :
  1. Time to Complete or Partial Overall Clinical Response [ Time Frame: up to 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Participant has proven or probable IPA according to the 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 an unfavorable response 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 is participating, or who is due to participate at any time during the study, in a therapeutic or diagnostic clinical trial.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05238116


Contacts
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Contact: Chief Medical Officer +44 (0)203 763 9484 admin@pulmocide.com

Locations
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United States, California
Clinical Research Site Recruiting
Duarte, California, United States, 91010
Contact: Clinical R Site         
United States, Indiana
Clinical Research Site Recruiting
Indianapolis, Indiana, United States, 46202
Principal Investigator: Investigator         
United States, Kentucky
Clinical Research Site Recruiting
Lexington, Kentucky, United States, 40506
Contact: Clinical R Site         
United States, Massachusetts
Clinical Research Site Recruiting
Boston, Massachusetts, United States, 02115
Contact: Research Coordinator         
United States, Minnesota
Clinical Research Site Recruiting
Minneapolis, Minnesota, United States, 18014
Contact: Clinical R Site         
United States, Missouri
Clinical Research Site Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Clinical R Site         
United States, New York
Clinical Research Site Recruiting
Bronx, New York, United States, 10467
Contact: Research Site         
United States, Pennsylvania
Clinical Research Site Recruiting
Philadelphia, Pennsylvania, United States, 19014
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Clinical Research Site Recruiting
Pittsburgh, Pennsylvania, United States, 15213
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United States, Tennessee
Clinical Research Site Recruiting
Nashville, Tennessee, United States, 37232
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United States, Texas
Clinical Research Site Recruiting
Houston, Texas, United States, 77030
Contact: Clinical R Site         
Clinical Research Site Recruiting
Houston, Texas, United States, 77032
Principal Investigator: Investigator         
United States, Washington
Clinical Research Site Recruiting
Seattle, Washington, United States, 19024
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Austria
Clinical Research Site Recruiting
Graz, Austria, 8036
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Clinical Research Site Recruiting
Graz, Austria
Clinical Research Site Recruiting
Vienna, Austria
Principal Investigator: Clinical R Site         
Belgium
Clinical Research Site Recruiting
Brussels, Belgium, 1070
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Clinical Research Site Recruiting
Leuven, Belgium, 3000
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Canada
Clinical Research Site Not yet recruiting
Hamilton, Canada, L8V1C3
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Clinical Research SIte Not yet recruiting
Toronto, Canada, M5G 2N2
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France
Clinical Research Site Recruiting
Bordeaux, France, 33604
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Clinical Research Site Recruiting
Strasbourg, France
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Greece
Clinical Research Site Recruiting
Athens, Greece
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Clinical Research Site Recruiting
Exochí, Greece
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Israel
Clinical Research Site Recruiting
Haifa, Israel, 3109601
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Clinical Research Site Recruiting
Haifa, Israel
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Clinical Research Site Recruiting
Ramat Gan, Israel, 5266202
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Italy
Clinical Research Site Recruiting
Brescia, Italy, 25123
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Clinical Research Site Recruiting
Milan, Italy, 20111
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Clinical Research Site Recruiting
Rome, Italy, 168
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Clinical Research Site Recruiting
Siena, Italy, 53100
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Korea, Republic of
Clinical Research Site Recruiting
Seoul, Korea, Republic of, 06591
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Spain
Clinical Research Site Recruiting
Barcelona, Spain, 8035
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Clinical Research Site Recruiting
Barcelona, Spain, 8036
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Clinical Research Site Recruiting
Córdoba, Spain, 14004
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Clinical Research Site Recruiting
Granada, Spain, 18014
Clinical Research Site Not yet recruiting
Madrid, Spain, 28222
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Clinical Research Site Recruiting
Santander, Spain, 46026
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Clinical Research Site Recruiting
Valencia, Spain, 39008
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Taiwan
Clinical Research Site Recruiting
Taipei, Taiwan, 10048
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United Kingdom
Clinical Research Site Recruiting
Harefield, United Kingdom
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Sponsors and Collaborators
Pulmocide Ltd
More Information
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Responsible Party: Pulmocide Ltd
ClinicalTrials.gov Identifier: NCT05238116    
Other Study ID Numbers: PC_ASP_006
2021-004554-32 ( EudraCT Number )
First Posted: February 14, 2022    Key Record Dates
Last Update Posted: May 8, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pulmocide Ltd:
Refractory IPA
invasive pulmonary aspergillosis
Additional relevant MeSH terms:
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Aspergillosis
Pulmonary Aspergillosis
Invasive Pulmonary Aspergillosis
Mycoses
Bacterial Infections and Mycoses
 Infections
Lung Diseases, Fungal
Lung Diseases
Respiratory Tract Diseases
Invasive Fungal Infections