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A Safety Study of PC945 (Opelconazole) Prophylaxis or Pre-emptive Therapy Against Pulmonary Aspergillosis in Lung Transplant Recipients (OPERA-S Study)

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. Read our disclaimer for details. Identifier: NCT05037851
Recruitment Status : Completed
First Posted : September 8, 2021
Last Update Posted : January 12, 2024
Information provided by (Responsible Party):
Pulmocide Ltd

Brief Summary:
A study to evaluate the safety and tolerability of opelconazole for the prevention of fungal aspergillus infections in the lung in participants who have received a lung transplant.

Condition or disease Intervention/treatment Phase
Pulmonary Aspergillosis Drug: Opelconazole Drug: Standard of Care Phase 2

Detailed Description:

Part 1 of the study comprises a 12 week Prophylaxis or Pre-emptive Therapy Phase. Part 2 comprises a 4-week Safety Follow-Up Phase.

The study will screen single or double lung transplant recipients due to receive a mold-active antifungal: either as de novo prophylaxis or as pre-emptive therapy (for participants with Aspergillus spp. colonization of the respiratory tract but no evidence of pulmonary fungal disease). Only participants who fulfill all the inclusion and none of the exclusion criteria will be randomized.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open-label, randomized, active-controlled, parallel-group multi-center study
Masking: None (Open Label)
Masking Description: The study will be an open-label study. For the purposes of the exploratory efficacy assessments, however, the Data Review Committee determining the presence of pulmonary fungal disease will be blinded as to treatment assignment. The Sponsor will limit knowledge of treatment assignment to as few sponsor personnel as possible to reduce bias.
Primary Purpose: Prevention
Official Title: A Randomized Controlled Open-label Study to Assess the Safety and Tolerability of Nebulized PC945 for Prophylaxis or Pre-emptive Therapy Against Pulmonary Aspergillosis in Lung Transplant Recipients (OPERA-S Study)
Actual Study Start Date : November 19, 2021
Actual Primary Completion Date : October 19, 2023
Actual Study Completion Date : November 13, 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Opelconazole
14.8 mg opelconazole administered twice daily for 12 weeks
Drug: Opelconazole
Nebulizer suspension
Other Name: PC945

Active Comparator: Standard of Care (SoC)
Mold-active SoC prophylaxis/pre-emptive therapy
Drug: Standard of Care
Standard of Care

Primary Outcome Measures :
  1. Number of participants who complete 12 weeks of therapy [ Time Frame: Baseline to 12 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Key Inclusion Criteria:

2. Participant has received either a single or double lung transplant but did not receive any other organ transplant (e.g., heart, kidney, etc.) at the time of the lung transplantation. History of prior transplant (>1 year) is acceptable

6a. (De novo prophylaxis immediately post transplant): participant must be ready to be randomized and start anti-mold prophylaxis within 72 hours of returning to the intensive care unit (ICU) after the transplant surgery or

6b. (Pre-emptive therapy): participant must meet all of the following:

  • Aspergillus spp. colonization of the respiratory tract confirmed within 91 days (13 weeks) after a lung transplant. Colonization is defined according to the 2010 International Society for Heart Lung Transplantation (ISHLT) Consensus Statement definition criteria for colonization
  • Without evidence of pulmonary fungal disease
  • Must be ready to start anti-mold medication within 96 hours after the positive culture(s), galactomannan or polymerase chain reaction (PCR) result(s) were reported

Key Exclusion Criteria:

  1. Participant would normally receive nebulized amphotericin B as the only mold active antifungal agent as initial SoC prophylaxis or pre-emptive therapy
  2. Fungal disease requiring systemic antifungal treatment at the time of transplant
  3. Has received a mold active antifungal agent post-transplant (Note: a participant who receives a mold active antifungal agent within 24 hours before, during, or after the transplant procedure will not be excluded if the mold active medication was stopped within 72 hours of returning to the ICU after the transplant surgery, or prior to randomization (whichever happens first)
  4. Has previously received opelconazole
  5. Is receiving, or who is due to receive at any time during the study, an investigational medicinal agent
  6. Is participating, or who is due to participate at any time during the study, in a therapeutic clinical trial. For any other trials (e.g. observational or using approved medication), consultation with Pulmocide and the medical monitor is required.
  7. Has an endobronchial stent in situ
  8. Known history of allergy, hypersensitivity, or any previous serious reaction to any component of the opelconazole formulation, azoles, echinocandins, or amphotericin B
  9. Elevated alanine transaminase (ALT) or, aspartate transaminase (AST) > 5 x the upper limit of normal (ULN)
  10. Any known history or current evidence of alcohol or drug abuse that, in the Investigator's opinion, would exclude the participant from participation in the study

12. Life expectancy is not expected to be sustained for the duration of the trial (16 weeks), in the opinion of the investigator

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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 identifier (NCT number): NCT05037851

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United States, Arizona
Clinical Research Site
Phoenix, Arizona, United States, 85013
United States, California
Clinical Research Site
La Jolla, California, United States, 92037
Clinical Research Site
Los Angeles, California, United States, 90095
United States, Florida
Clinical Research Site
Jacksonville, Florida, United States, 32224
Clinical Research Site
Tampa, Florida, United States, 33606
United States, Illinois
Clinical Research Site
Maywood, Illinois, United States, 60153
United States, Missouri
Research Site
Saint Louis, Missouri, United States, 63110
United States, New York
Clinical Research Site
Bronx, New York, United States, 10467
Clinical Research Site
New York, New York, United States, 10016
United States, Pennsylvania
Clinical Research Site
Philadelphia, Pennsylvania, United States, 19104
Clinical Research Site
Philadelphia, Pennsylvania, United States, 19140
Clinical Research Site
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Clinical Research Site
Nashville, Tennessee, United States, 37232
United States, Texas
Clinical Research Site
Dallas, Texas, United States, 75246
Clinical Research Site 1
Houston, Texas, United States, 77030
Clinical Research Site 2
Houston, Texas, United States, 77030
Clinical Research Site 3
Houston, Texas, United States, 77030
Clinical Research Site
Edmonton, Canada, T6G 1Z1
Clinical Research Site
Toronto, Canada, M5G 2N2
Sponsors and Collaborators
Pulmocide Ltd
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Study Director: Vice President Clinical Development Pulmocide Ltd
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Responsible Party: Pulmocide Ltd Identifier: NCT05037851    
Other Study ID Numbers: PC_ASP_007
First Posted: September 8, 2021    Key Record Dates
Last Update Posted: January 12, 2024
Last Verified: January 2024
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
Additional relevant MeSH terms:
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Pulmonary Aspergillosis
Bacterial Infections and Mycoses
Lung Diseases, Fungal
Lung Diseases
Respiratory Tract Diseases