RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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 (OPERA-T Study)

Quick Facts

Study Start:2022-06-14
Study Completion:2025-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05238116

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. Participant's IPA has failed to respond to adequate antifungal therapy.
  1. 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. 2. Participant who has previously received PC945.
  3. 3. Participant with a known history of allergy, hypersensitivity, or any previous serious reaction to any component of the PC945 or placebo formulations.
  4. 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

Contacts and Locations

Study Contact

Chief Medical Officer
CONTACT
+44 (0)203 763 9484
admin@pulmocide.com
Senior Medical Director of Clinical Development
CONTACT
is +44 (0) 203 763 9484
admin@pulmocide.com

Study Locations (Sites)

Clinical Research Site 029
Duarte, California, 91010
United States
Clinical Research Site 009
La Jolla, California, 1801492037
United States
Clinical Research Site 119
Sacramento, California, 95817
United States
Clinical Research Site 031
Jacksonville, Florida, 32224
United States
Clinical Research Site 022
Indianapolis, Indiana, 46202
United States
Clinical Research Site 023
Lexington, Kentucky, 40506
United States
Clinical Research Site 025
Boston, Massachusetts, 02115
United States
Clinical Research Site 111
Ann Arbor, Michigan, 48109
United States
Clinical Research Site 095
Minneapolis, Minnesota, 55455
United States
Clinical Research Site 010
Saint Louis, Missouri, 63110
United States
Clinical Research Site 018
Bronx, New York, 10467
United States
Clinical Research Site 002
Philadelphia, Pennsylvania, 19014
United States
Clinical Research Site 001
Pittsburgh, Pennsylvania, 15213
United States
Clinical Research Site 030
Nashville, Tennessee, 37232
United States
Clinical Research Site 003
Houston, Texas, 77030
United States
Clinical Research Site 028
Houston, Texas, 77030
United States
Clinical Research Site 118
Houston, Texas, 77030
United States
Clinical Research Site 026
Seattle, Washington, 98109
United States
Clinical Research Site 032
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: 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 Registration Dates

Study Start Date2022-06-14
Study Completion Date2025-12-30

Study Record Updates

Study Start Date2022-06-14
Study Completion Date2025-12-30

Terms related to this study

Keywords Provided by Researchers

  • Refractory IPA
  • invasive pulmonary aspergillosis

Additional Relevant MeSH Terms

  • Refractory IPA