AzTrials
AzTrials

AspergillosisPhase 2NCT03905447

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

A Phase 2 study testing PC945 in people with Aspergillosis and Lung Transplant Infection, run by Pulmocide Ltd at 3 sites in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Aspergillosis, Lung Transplant Infection
What is being tested?
PC945
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
3 sitesUnited Kingdom
Study dates
17 Sep 2019to 1 Jun 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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).
  • Inclusion Criteria (Follow-up Phase - SOC Antifungal Treatment)
  • 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 (Follow-up Phase - SOC Antifungal Treatment)
  • 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.

Trial locations and contacts

3 sites in 1 country.

United Kingdom3 sites

  • Harefield Hospital

    Harefield, Uxbridge, UB9 6JH

  • Wythenshawe Hospital

    Manchester, M23 9LT

  • Papworth Hospital

    Papworth Everard, Cambridge, CB23 3RE

Other trials in United Kingdom

About this study

Official title: An Open-label, Pilot Study to Assess Safety, Tolerability, Pharmacokinetics and Effects of Inhaled PC945 in the Pre-emptive Treatment of Aspergillus Fumigatus Colonisation in Lung Transplant Recipients

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.

Being tested
PC945, Standard of Care
Medical subject headings
Aspergillosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PC945Drug

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

  • Standard of CareDrug

    Standard of Care antifungal medication

Study groups in NCT03905447
Study groupRoleWhat they receive
PC945ExperimentalNot described
Receives: Drug: PC945
Standard of CareOtherStandard of care anti-fungal medication
Receives: Drug: Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events (AEs)

    Measured: 48 hours Post Transplant to Week 16 post treatment

  2. Proportion of participants receiving PC945 who meet the markedly abnormal criteria for 12-lead ECG assessment at lease once post dose

    Measured: Baseline to Week 16

  3. Proportion of participants receiving PC945 who meet the markedly abnormal criteria for vital signs assessment at lease once post dose

    Measured: Baseline to Week 16

  4. Proportion of participants receiving PC945 who meet the markedly abnormal criteria for safety laboratory assessment at lease once post dose

    Measured: Baseline to Week 16

  5. Predicted post bronchodilator forced expiratory volume in 1 second (FEV1) values from participants receiving PC945

    Measured: Baseline to Week 16

  6. Forced vital capacity (FVC) values from participants receiving PC945

    Measured: Baseline to Week 16

  7. Area under the curve from time 0 to 2 h post-dose (AUC0-2)

    Derived pharmacokinetic parameters for PC945 and the potential circulating metabolite(s), if detectable

    Measured: Baseline to Week 16

  8. Maximum plasma concentration

    Derived pharmacokinetic parameters for PC945 and the potential circulating metabolite(s), if detectable

    Measured: Baseline to Week 16

  9. Concentration at the end of the dosage interval (Ctrough)

    Derived pharmacokinetic parameters for PC945 and the potential circulating metabolite(s), if detectable

    Measured: Baseline to Week 16

Secondary outcomes (9)

  1. Lung Concentration of PC945

    Measured: Baseline to Week 16

  2. A. fumigatus fungal culture status (presence or absence) in subjects with a baseline A. fumigatus-positive bronchoalveolar lavage (BAL)

    Measured: Baseline to Week 16

  3. Change in BAL A. fumigatus measured by quantitative polymerase chain reaction (qPCR)

    Measured: Baseline to Week 16

  4. Change in the number of sputum A. fumigatus colony forming units (CFU) in cultured BAL.

    Measured: Baseline to Week 16

  5. Galactomannan levels in BAL

    Measured: Baseline to Week 16

  6. Aspergillus status (Presence or absence) of BAL using an Aspergillus immunochromatographic lateral flow device (AspLFD).

    Measured: Baseline to Week 16

  7. Status of fungal hyphae or pseudohyphae (presence or absence) on cytological examination

    Measured: Baseline to Week 16

  8. Subject experience of inhaled PC945

    Assessed by a standardised study-specific questionnaire assessing participants' subjective experience across a number of domains including taste, smell and overall acceptability following inhalation of PC945.

    Measured: Baseline to Week 16

  9. Subject experience of inhaled amphotericin B

    Assessed by a standardised study-specific questionnaire assessing participants' subjective experience across a number of domains including taste, smell and overall acceptability, following inhalation of amphotericin B.

    Measured: Baseline to Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2019
  2. Study start17 Sep 2019
  3. Primary completion1 Jun 2020
  4. Study completion1 Jun 2020

Why it stopped: The study is being terminated early as a result of the coronavirus (COVID-19) outbreak.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Subjects in the surveillance phase with detectable Aspergillus fumigatus lung infections WITHOUT clinical symptoms will be eligible to receive PC945 for 28 days. Following 28 days on PC945, subjects with ongoing A. fumigatus lung infections may receive a further 56 days of PC945. Subjects in the surveillance phase with EITHER detectable Aspergillus fumigatus lung infections WITH clinical symptoms, OR other fungal lung infection, will be eligible to be followed up for 16 weeks on Standard of Care.
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03905447
Sponsor's protocol ID
PC_ASP_002
Other IDs
2018-000240-26, 2018
Status last verified
Jun 2020
First submitted
6 Mar 2019
Last updated
16 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PC945 in people with Aspergillosis and Lung Transplant Infection, run by Pulmocide Ltd at 3 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The study is being terminated early as a result of the coronavirus (COVID-19) outbreak.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events (AEs) (time frame: 48 hours Post Transplant to Week 16 post treatment). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03905447.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in