Evaluating the Test Performance of Aspergillus Antigen Detection Using a Lateral-flow Device (LFD) on Broncho-alveolar Lavage (BAL) Fluid for the Diagnosis of Invasive Pulmonary Aspergillosis in Paediatrics: A Pilot Study

Status: Unknown
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Maximum Age: 18
Healthy Volunteers: f
View:

• Paediatric patients aged less than 18 years who are clinically identified as requiring investigation for pulmonary IA/IFD and hence are undergoing a BAL as part of clinical care

• Written informed consent

Locations
Other Locations
United Kingdom
St George's University Hospitals NHS Foundation Trust
RECRUITING
London
Contact Information
Primary
Laura Ferreras-Antolin
laura.ferrerasantolin@nhs.net
02087251683
Time Frame
Start Date: 2022-06-10
Completion Date: 2024-04-29
Participants
Target number of participants: 20
Treatments
Prospective Study Pathway
Child or young person undergoing a Broncho-alveolar Lavage (BAL) for suspected pulmonary Invasive Fungal Disease (IFD) and consent obtained.
Related Therapeutic Areas
Sponsors
Collaborators: Fungal Infection Trust, St George's, University of London, University of Exeter, University College, London
Leads: St George's University Hospitals NHS Foundation Trust

This content was sourced from clinicaltrials.gov