Clinical trial NCT05569824: LFD of Aspergillus Antigen in Paediatrics
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Invasive Pulmonary Aspergillosis
Invasive Fungal Disease
Keywords: Lateral-flow Device
Aspergillus
Broncho-alveolar Lavage
Invasive Pulmonary Aspergillus
Paediatrics
Aspergillus Antigen Detection
Invasive Fungal Disease
Lead sponsor: St George's, University of London
Sponsor class: OTHER
Collaborators: name: University of Exeter
name: University College, London
name: St George's, University of London
name: Fungal Infection Trust
First posted: 2022-10-06
Enrollment: 20
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible patients undergoing a BAL for suspected IA/IFD at St George's University Hospitals NHS Foundation Trust (United Kingdom).

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Patients who are undergoing a BAL for other indications than suspected invasive fungal lung disease
* Patients ≥ 18 years of age

Primary outcomes:
measure: The proportion of children whose diagnosis has been supported by the LFD test
timeFrame: Through study completion, an average of 2 years
measure: The sensitivity of test results compared to culture and PCR results
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St George's University Hospitals NHS Foundation Trust
Study officials:
affiliation: St George's University Hospitals NHS Foundation Trust
name: Laura Ferreras-Antolin
role: PRINCIPAL_INVESTIGATOR
References: