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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Beatriz Morais
bmorais@sgul.ac.uk


Dr Laura Ferreras-Antolin
laura.ferrerasantolin@nhs.net


Study Location:

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Be Part of Research - Trial Details - LFD-AsPaeds

LFD-AsPaeds

Recruiting

Open to: Female / Male

Age: 0 Years - 17 Years

Medical Conditions

Mycoses


This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.


Invasive aspergillosis (IA) has high rates of mortality in immunocompromised children, such as those
with a primary immunodeficiency, haematological malignancy and children undergoing haematopoietic stem cell transplants (HSCT). IA is notoriously difficult to distinguish clinically from bacterial or mycobacterial disease. Prompt diagnosis of fungal disease leads to better outcomes for patients. Furthermore, safely stopping antifungal treatment early reduces toxicity and gives significant cost savings.

Culture and tissue confirmation of Aspergillus spp. invasive growth are the gold standard for diagnosing proven IA. However, Aspergillus spp. are unreliably cultured from tissue and are rarely isolated from blood cultures. Hence, additional investigations are recommended by the European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group
(EORTC): Computed Tomography (CT) of the chest and the use of Galactomannan (GM) antigen testing. But imaging and GM test have limitations in paediatrics. That is why, there is a need to develop more both accurate and rapid diagnostics with higher sensitivities and specificities.

Currently there is a focus on lateral-flow devices (LFDs), which are point-of-care tests that can be read by the naked eye, allowing a diagnosis in 15 minutes. LFDs utilise the immunochromatographic monoclonal antibody that detects mannoproteins which are specific for Aspergillus spp. and produced during active growth. LFDs have given promising in the adult population, but there is no current published research into LFDs of BAL used to diagnose IA in paediatrics; being reasonable to suggest that the use of LFDs in the population may yield a rapid and accurate diagnosis in children too.

We are aiming to evaluate the use of LFDs children with cancer, who as part of their diagnostic workup undergo a BAL and assess whether the use of LFDs test adds to the diagnostic yield that we have with the standard methods already in place.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

09 Jun 2022 01 Jan 2025

Observational

Observational type: Validation of investigation /therapeutic procedures;



You can take part if:



You may not be able to take part if:


- Patients who are undergoing a BAL for other indications than suspected invasive fungal lung disease. - Informed consent not signed. - Patients > = 18 years of age.


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • St George's Hospital (tooting)
    Blackshaw Road
    London
    Greater London
    SW17 0QT

Beatriz Morais
bmorais@sgul.ac.uk


Dr Laura Ferreras-Antolin
laura.ferrerasantolin@nhs.net



The study is sponsored by ST GEORGE'S UNIVERSITY HOSPITALS NHS FOUNDATION TRUST and funded by FUNGAL INFECTION TRUST .




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for Trial ID: CPMS 52069

Last updated 21 November 2024

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