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

NCT ID: NCT03905447

Last Updated: 2021-07-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-17
• Study Completion Date: 2020-06-01

Brief 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.

Conditions

Aspergillosis; Lung Transplant Infection

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PC945

Group Type: EXPERIMENTAL

PC945

Intervention Type: DRUG

Nebulized PC945 5mg OD for 28 days with an optional extended treatment period of a further 56 days.

Standard of Care

Standard of care anti-fungal medication

Group Type: OTHER

Standard of Care

Intervention Type: DRUG

Standard of Care antifungal medication

Interventions

PC945

Nebulized PC945 5mg OD for 28 days with an optional extended treatment period of a further 56 days.

Intervention Type: DRUG

Standard of Care

Standard of Care antifungal medication

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Between the ages of 18 and 85 years.
• Received a single or bilateral lung transplant.
• Provided written informed consent prior to transplant

• A positive test for A. fumigatus in BAL during the Surveillance Phase of the study
• Provided written informed consent for participating in the Pre-Emptive Treatment Phase.

• Subject is not eligible to receive pre-emptive PC945 treatment due to either clinical, endobronchial and/or radiological features of fungal disease OR a fungal infection other than A. fumigatus in BAL, that requires SoC antifungal treatment to be started during the Surveillance Phase of the study.
• Provided written informed consent for participating in the Follow-Up Phase for SoC antifungal treatment.

Exclusion Criteria

• Is precluded from participating in this study as a result of treatment with another investigational drug or participation in another clinical trial.
• If female, the subject is pregnant, lactating or breast feeding.
• Any other clinically significant disease or condition, which in the Investigator's medical opinion would preclude the subject's participation in a clinical trial (e.g., recent myocardial infarction).
• Is employed or is a first-degree relative of anyone employed by Pulmocide, a participating clinical trial site, or any contract research organisation involved in the study.
• Is receiving antiretroviral protease inhibitor therapy.
• Has human immunodeficiency virus or chronic, active hepatitis infection, or had a positive hepatitis B surface antigen or hepatitis C virus RNA test prior to transplant.
• Any known history or current evidence of alcohol or drug abuse that, in the Investigator's opinion, would exclude the subject from participation in the study

• Clinical, endobronchial and/or radiological features of fungal disease.*
• Any other disease or condition, which in the Investigator's medical opinion would preclude the subject's participation in the Pre-Emptive Treatment Phase of the study (e.g., recent myocardial infarction).

• Any other disease or condition, which in the Investigator's medical opinion would preclude the subject's participation in the Follow-Up Phase for SoC antifungal treatment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pulmocide Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Papworth Hospital

Papworth Everard, Cambridge, United Kingdom

Harefield Hospital

Harefield, Uxbridge, United Kingdom

Wythenshawe Hospital

Manchester, , United Kingdom

Countries

United Kingdom

Other Identifiers

2018-000240-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PC_ASP_002

Identifier Type: -

Identifier Source: org_study_id