drugset / Trial / NCT03905447

The Effect of Early Treatment of PC945 on Aspergillus Fumigatus Lung Infection in Lung Transplant Patients.

NCT03905447 ↗

Phase 2 Terminated 2 enrolled Pulmocide Ltd
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study tests the effects of pre-emptive treatment with an experimental drug PC945 in lung transplant recipients whose lungs are infected by the fungus Aspergillus fumigatus. PC945 may be useful in treating patients infected with Aspergillus fumigatus as, unlike the usual treatments, it is inhaled into the lung and has been designed to stay there and treat the infection. Participants will be monitored for up-to 12 weeks for the presence of Aspergillus in their lungs. Suitable participants will receive PC945 for an initial 28 days (Pre-emptive treatment phase) and, if needed, a further 8-weeks (Extended treatment phase).The amount of fungus in the patients' lungs will be measured over the course of the study. Participants with lung infections but not eligible for PC945 will be followed-up for 16-weeks on standard of care treatment. The study will take place at multiple sites in UK and 10 participants will receive PC945. The maximum study duration will be about 28 weeks.

Timeline

Start
2019-09-17
Primary completion
2020-06-01
Completion
2020-06-01

Outcome

Outcome not reported

Stopped: “The study is being terminated early as a result of the coronavirus (COVID-19) outbreak.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Opelconazole Small molecule 5 mg Inhaled