A Study of Inhaled PC945 in Patients who have had a Lung Transplant which will Investigate the Safety of PC945, how the Body Affects the Drug and how the Drug Affects the Body

Phase 1

• Conditions: Pre-emptive treatment of Aspergillus fumigatus colonisation in lung transplant recipients; MedDRA version: 20.0Level: LLTClassification code 10059259Term: Pulmonary aspergillosisSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2018-000240-26-GB
• Lead Sponsor: Pulmocide Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-16
• Last Update Posted: 13 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Surveillance Phase:
1. Between the ages of 18 and 85 years.
2. Received a single or bilateral lung transplant.
3. Provided written informed consent prior to transplant.

Pre-emptive treatment phase:
1. A positive test for A. fumigatus in BAL during the Surveillance Phase of the study
2. Provided written informed consent for participating in the Pre-Emptive Treatment Phase.

Follow-up Phase:
1. 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.
2. Provided written informed consent for participating in the follow-up phase for SoC antifungal treatment.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

Surveillance Phase:

1. Is precluded from participating in this study as a result of treatment with another investigational drug or participation in another clinical trial.
2. If female, the subject is pregnant, lactating or breast feeding.
3. 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).
4. 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.
5. Is receiving antiretroviral protease inhibitor therapy.
6. 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.
7. 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.

Pre-emptive Treatment Phase:
1. Clinical, endobronchial and/or radiological features of fungal disease.
2. 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).

Follow-up Phase:
1. 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified