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Clinical Trial Summary

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.

Clinical Trial 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 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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05037851
Study type Interventional
Source Pulmocide Ltd
Contact Chief Medical Officer
Phone +44 (0)203 763 9484
Email [email protected]
Status Not yet recruiting
Phase Phase 2
Start date September 2021
Completion date July 2022

See also
  Status Clinical Trial Phase
Not yet recruiting NCT04530799 - Prospective Observational Trial of IAPA
Completed NCT03443336 - Azole-resistance in Aspergillus