LFD of Aspergillus Antigen in Paediatrics (LFD-AsPaeds)

October 11, 2022 updated by: St George's University Hospitals NHS Foundation Trust

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The proportion of children whose diagnosis has been supported by the LFD test
Time Frame: Through study completion, an average of 2 years
Through study completion, an average of 2 years
The sensitivity of test results compared to culture and PCR results
Time Frame: Through study completion, an average of 2 years
Through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St George's University Hospitals NHS Foundation Trust

Collaborators

University College, London
St George's, University of London
University of Exeter
Fungal Infection Trust

Investigators

  • Principal Investigator: Laura Ferreras-Antolin, St George's University Hospitals NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 10, 2022

Primary Completion (ANTICIPATED)

January 19, 2024

Study Completion (ANTICIPATED)

April 29, 2024

Study Registration Dates

First Submitted

August 17, 2022

First Submitted That Met QC Criteria

October 3, 2022

First Posted (ACTUAL)

October 6, 2022

Study Record Updates

Last Update Posted (ACTUAL)

October 13, 2022

Last Update Submitted That Met QC Criteria

October 11, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 292170

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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