Ignite Creation Date:
2024-05-06 @ 6:09 PM
Last Modification Date:
2024-10-26 @ 2:43 PM
Study NCT ID:
NCT05569824
Status:
UNKNOWN
Last Update Posted:
2022-10-13
First Post:
2022-08-17
Brief Title:
LFD of Aspergillus Antigen in Paediatrics
Sponsor:
St Georges University Hospitals NHS Foundation Trust
Organization:
St Georges University of London
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2022-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LFD-AsPaeds
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 lungsairway
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 lungsairway 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
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 lungsairway 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 IAIFD 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 IAIFD at St Georges 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 InclusionExclusion 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
If patients are scheduled to have a BAL sample and meet the InclusionExclusion 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None