Pulmonary Aspergillosis Clinical Trial
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
A study to evaluate the safety and tolerability of PC945 for the prevention of fungal aspergillus infections in the lung in patients 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 subjects with Aspergillus spp. colonization of the respiratory tract but no evidence of pulmonary fungal disease). Only subjects who fulfill all the inclusion and none of the exclusion criteria will be randomized. The presence of post-randomization pulmonary fungal disease or colonization will be adjudicated in all subjects in a blinded fashion by an independent Data Review Committee (DRC) using the 2010 International Society for Heart and Lung Transplant criteria [Husain S et al., 2011]. Pulmonary fungal disease will be categorized by the DRC as bronchial anastomotic infection, tracheobronchitis, fungal pneumonia, or colonization, and will be further categorized as proven or probable. ;