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

Primary Purpose

Refractory IPA

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
PC945
Placebo
Sponsored by
Pulmocide Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractory IPA focused on measuring Refractory IPA, invasive pulmonary aspergillosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PC945

Placebo

Arm Description

PC945 dose, administered via nebulizer, twice daily

PC945-placebo administered via nebulizer, twice daily

Outcomes

Primary Outcome Measures

Number of Participants with Complete or Partial Overall Response

Secondary Outcome Measures

Time to Complete or Partial Overall Clinical Response

Full Information

First Posted
February 3, 2022
Last Updated
September 26, 2023
Sponsor
Pulmocide Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05238116
Brief Title
Safety and Efficacy of PC945 in Combination With Other Antifungal Therapy for the Treatment of Refractory Invasive Pulmonary Aspergillosis
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 14, 2022 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pulmocide Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory IPA
Keywords
Refractory IPA, invasive pulmonary aspergillosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double Blind
Allocation
Randomized
Enrollment
123 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PC945
Arm Type
Experimental
Arm Description
PC945 dose, administered via nebulizer, twice daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
PC945-placebo administered via nebulizer, twice daily
Intervention Type
Drug
Intervention Name(s)
PC945
Intervention Description
Sterile aqueous liquid for Nebulization
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Sterile aqueous liquid for Nebulization
Primary Outcome Measure Information:
Title
Number of Participants with Complete or Partial Overall Response
Time Frame
up to 12 weeks
Secondary Outcome Measure Information:
Title
Time to Complete or Partial Overall Clinical Response
Time Frame
up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Participant's IPA has an unfavorable response to adequate antifungal therapy. Exclusion Criteria: 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. Participant who has previously received PC945. Participant with a known history of allergy, hypersensitivity, or any previous serious reaction to any component of the PC945 or placebo formulations. Participant who is participating, or who is due to participate at any time during the study, in a therapeutic or diagnostic clinical trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chief Medical Officer
Phone
+44 (0)203 763 9484
Email
admin@pulmocide.com
Facility Information:
Facility Name
Clinical Research Site
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical R Site
Facility Name
Clinical Research Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Investigator
Facility Name
Clinical Research Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical R Site
Facility Name
Clinical Research Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Facility Name
Clinical Research Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
18014
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical R Site
Facility Name
Clinical Research Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical R Site
Facility Name
Clinical Research Site
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Site
Facility Name
Clinical Research Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19014
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical R Site
Facility Name
Clinical Research Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical R Site
Facility Name
Clinical Research Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical R Site
Facility Name
Clinical Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical R Site
Facility Name
Clinical Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Investigator
Facility Name
Clinical Research Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
19024
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical R Site
Facility Name
Clinical Research Site
City
Buenos Aires
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical R Site
Facility Name
Clinical Research Site
City
Graz
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical R Site
Facility Name
Clinical Research Site
City
Vienna
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical R Site
Facility Name
Clinical Research Site
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical R Site
Facility Name
Clinical Research Site
City
Brussels
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical R Site
Facility Name
Clinical Research Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical R Site
Facility Name
Clinical Research Site
City
Jau
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical R Site
Facility Name
Clinical Research Site
City
Rio Grande
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical R Site
Facility Name
Clinical Research Site
City
Santa Catarina
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical R Site
Facility Name
Clinical Research Site
City
Hamilton
ZIP/Postal Code
L8V1C3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical R Site
Facility Name
Clinical Research SIte
City
Toronto
ZIP/Postal Code
M5G 2N2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical R SIte
Facility Name
Clinical Research Site
City
Bordeaux
ZIP/Postal Code
33604
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical R Site
Facility Name
Clinical Research Site
City
Strasbourg
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical R Site
Facility Name
Clinical Research Site
City
Cologne
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical R Site
Facility Name
Clinical Research Site
City
Frankfurt
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical R Site
Facility Name
Clinical Research Site
City
Würzburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical R Site
Facility Name
Clinical Research Site
City
Athens
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical R Site
Facility Name
Clinical Research Site
City
Exochí
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical R Site
Facility Name
Clinical Research Site
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical R Site
Facility Name
Clinical Research Site
City
Ramat Gan
ZIP/Postal Code
5266202
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical R Site
Facility Name
Clinical Research Site
City
Safed
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical R Site
Facility Name
Clinical Research Site
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical R Site
Facility Name
Clinical Research Site
City
Milan
ZIP/Postal Code
20111
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical R Site
Facility Name
Clinical Research Site
City
Monza
ZIP/Postal Code
18014
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical R Site
Facility Name
Clinical Research Site
City
Naples
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical R Site
Facility Name
Clinical Research Site
City
Rome
ZIP/Postal Code
168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical R Site
Facility Name
Clinical Research Site
City
Siena
ZIP/Postal Code
53100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical R Site
Facility Name
Clinical Research Site
City
Daejeon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical R Site
Facility Name
Clinical Research Site
City
Gyeonggi do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical R Site
Facility Name
Clinical Research Site
City
Inchon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical R Site
Facility Name
Clinical Research Site
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical R Site
Facility Name
Clinical Research Site
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical R Site
Facility Name
Clinical Research Site
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical R Site
Facility Name
Clinical Research Site
City
Barcelona
ZIP/Postal Code
8036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical R Site
Facility Name
Clinical Research Site
City
Buenos Aires
ZIP/Postal Code
18014
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical R Site
Facility Name
Clinical Research Site
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical R Site
Facility Name
Clinical Research Site
City
Granada
ZIP/Postal Code
18014
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Madrid
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical R Site
Facility Name
Clinical Research Site
City
Santander
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical R Site
Facility Name
Clinical Research Site
City
Valencia
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical R Site
Facility Name
Clinical Research Site
City
Kaohsiung
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical R Site
Facility Name
Clinical Research Site
City
Tainan
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical R Site
Facility Name
Clinical Research Site
City
Taipei
ZIP/Postal Code
10048
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical R Site
Facility Name
Clinical Research Site
City
Tapei City
ZIP/Postal Code
1
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical R Site
Facility Name
Clinical Research Site
City
Tapei City
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical R Site
Facility Name
Clinical Research Site
City
Harefield
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical R Site

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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