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)

Status: Completed
Location: See all (19) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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

Locations
United States
Arizona
Clinical Research Site
Phoenix
California
Clinical Research Site
La Jolla
Clinical Research Site
Los Angeles
Florida
Clinical Research Site
Jacksonville
Clinical Research Site
Tampa
Illinois
Clinical Research Site
Maywood
Missouri
Research Site
St Louis
New York
Clinical Research Site
New York
Clinical Research Site
The Bronx
Pennsylvania
Clinical Research Site
Philadelphia
Clinical Research Site
Philadelphia
Clinical Research Site
Pittsburgh
Tennessee
Clinical Research Site
Nashville
Texas
Clinical Research Site
Dallas
Clinical Research Site 1
Houston
Clinical Research Site 2
Houston
Clinical Research Site 3
Houston
Other Locations
Canada
Clinical Research Site
Edmonton
Clinical Research Site
Toronto
Time Frame
Start Date: 2021-11-19
Completion Date: 2023-11-13
Participants
Target number of participants: 102
Treatments
Experimental: Opelconazole
14.8 mg opelconazole administered twice daily for 12 weeks
Active_comparator: Standard of Care (SoC)
Mold-active SoC prophylaxis/pre-emptive therapy
Related Therapeutic Areas
Sponsors
Leads: Pulmocide Ltd

This content was sourced from clinicaltrials.gov