LFD of Aspergillus Antigen in Paediatrics

Last updated: October 11, 2022
Sponsor: St George's University Hospitals NHS Foundation Trust
Overall Status: Active - Recruiting

Phase

N/A

Condition

Aspergillosis

Treatment

N/A

Clinical Study ID

NCT05569824
292170
  • Ages < 18
  • All Genders

Study Summary

Many children and young people are at risk of invasive fungal disease (IFD), such as those who have had a haematopoietic stem cell transplants, those with an immune deficiency or those who are prescribed immunosuppressive drugs, for example, corticosteroids. One type of mould that causes invasive fungal disease is called Aspergillus. There is currently no quick test which can tell us if someone has an invasive fungal disease caused by Aspergillus called Aspergillosis. It is a difficult condition to diagnose and the results from the tests that are involved take days or weeks to come back. These tests including a few different blood tests, a scan of the lungs (CT scans) and taking fluid from inside the lungs/airway.

A new test for Aspergillosis is the lateral flow device (LFD) assay. This is a rapid test which gives a result within minutes. It involves testing a sample of the fluid from the lungs/airway. This fluid can be obtained as part of the routine investigations for Aspergillosis. It has been shown to be a good and safe test in adults but the investigators do not know if it will be a valuable test in children and young people yet. The purpose of this study is to determine whether the LFD test can effectively diagnose Aspergillosis in children and young people.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Paediatric patients aged less than 18 years who are clinically identified as requiringinvestigation for pulmonary IA/IFD and hence are undergoing a BAL as part of clinicalcare
  • Written informed consent

Exclusion

Exclusion Criteria:

  • Patients who are undergoing a BAL for other indications than suspected invasive fungallung disease
  • Patients ≥ 18 years of age

Study Design

Total Participants: 20
Study Start date:
June 10, 2022
Estimated Completion Date:
April 29, 2024

Study Description

The overall study design is a prospective, single centre, cohort study in patients who have suspected pulmonary Invasive Aspergillosis (IA)/IFD and hence have a diagnostic BAL as part of their clinical care. A total number of 20 children <18 years of age undergoing a BAL for suspected IA/IFD at St George's Hospital University Hospitals NHS Foundation Trust (United Kingdom) will be enrolled. No changes in the regular diagnostic pathway or treatment will be done for this study.

If patients are scheduled to have a BAL sample and meet the Inclusion/Exclusion criteria the patients will be approached for consent at the same time as consent for the standard of care BAL procedure. With the patients consent the samples will be retrieved from the BAL fluid, both for the standard of care investigations (fungal culture, GM and fungal PCR in BAL fluid) and for the study sample. The minimal study sample required will be 1 ml. The study samples will be tested directly with the LFD for Aspergillus antigen when possible. Haemorrhagic or too viscous samples will need to be previously treated with a buffer (150 ul BAL with 300 ul buffer). Every individual participant patient will be followed up prospectively at two weeks and 3-months post-BAL to collate information.

Connect with a study center

  • St George's University Hospitals NHS Foundation Trust

    London, SW17 0QT
    United Kingdom

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.