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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
102
Nebulizer suspension
Standard of Care
Clinical Research Site
Phoenix, Arizona, United States
Clinical Research Site
La Jolla, California, United States
Number of participants who complete 12 weeks of therapy
Time frame: Baseline to 12 weeks
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Clinical Research Site
Los Angeles, California, United States
Clinical Research Site
Jacksonville, Florida, United States
Clinical Research Site
Tampa, Florida, United States
Clinical Research Site
Maywood, Illinois, United States
Research Site
St Louis, Missouri, United States
Clinical Research Site
New York, New York, United States
Clinical Research Site
The Bronx, New York, United States
Clinical Research Site
Philadelphia, Pennsylvania, United States
...and 9 more locations