LFD of Aspergillus Antigen in Paediatrics

NCT05569824 | Unknown

• 1 other identifier: 292170
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• The proportion of children whose diagnosis has been supported by the LFD test

  Through study completion, an average of 2 years

• The sensitivity of test results compared to culture and PCR results

  Through study completion, an average of 2 years

Study Arms (1)

Prospective Study Pathway

Child or young person undergoing a Broncho-alveolar Lavage (BAL) for suspected pulmonary Invasive Fungal Disease (IFD) and consent obtained.

Diagnostic Test: Lateral-flow Device

Interventions

Lateral-flow Device DIAGNOSTIC_TEST

An additional amount of 0.1-0.2 ml (2-4 drops) of bronco-alveolar lavage (BAL) fluid will be collected during the bronchoscopy which is carried out as part of the standard of care. The LFD test will be carried out on the BAL fluid collected.

Prospective Study Pathway

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• St George's University Hospitals NHS Foundation Trust: lead
• University of Exeter: collaborator
• University College, London: collaborator
• St George's, University of London: collaborator
• Fungal Infection Trust: collaborator

Study Sites (1)

St George's University Hospitals NHS Foundation Trust

London, SW17 0QT, United Kingdom

RECRUITING

Biospecimen

Bronco-alveolar lavage (BAL) fluid will be collected. If participants/parents/legal guardians provide consent Participants/parents/legal guardians can provide consent to the the anonymised samples will be stored for future ethically approved research.

MeSH Terms

Conditions

Invasive Pulmonary Aspergillosis; Invasive Fungal Infections

Condition Hierarchy (Ancestors)

Pulmonary Aspergillosis; Aspergillosis; Mycoses; Bacterial Infections and Mycoses; Infections; Lung Diseases, Fungal; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Laura Ferreras-Antolin

  St George's University Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Ferreras-Antolin

CONTACT

02087251683; laura.ferrerasantolin@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2022
• First Posted: October 6, 2022
• Study Start: June 10, 2022
• Primary Completion: January 19, 2024
• Study Completion: April 29, 2024
• Last Updated: October 13, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)