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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.
Dr
William
Hurt
+44 (0)2087255613
whurt@sgul.ac.uk
Dr
Tihana
Bicanic
+44 (0)2087255828
tbicanic@sgul.ac.uk
Aspergillosis
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. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Some patients with seasonal Influenza (‘flu’) develop severe infections requiring admission to the Intensive Care Unit (ICU) to support their breathing. Recent research has suggested that when patients have such severe influenza they may be susceptible to a second infection with a mould (a type of fungus) called Aspergillus. The mortality for patients infected with both severe ‘flu and Invasive pulmonary Aspergillus (IPA) is high but life-saving antifungal treatments exist and
thus it is important that a diagnosis of IA in patients with severe influenza is not missed. Unfortunately, IPA can be difficult and lengthy to diagnose in the laboratory and until recently it was only thought to occur in patients whose immune systems were severely impaired. This means that IPA in patients with severe influenza may be under-diagnosed currently and the main aim of this study is to establish how common this condition is in UK patients.
In 2020 a new coronavirus was identified as the cause of an outbreak of unexplained pneumonia in China. This coronavirus was later named ‘SARS-CoV-2’, and the disease it causes ‘COVID-19’. It is not yet known whether patients with severe COVID-19 infection are also at risk of IPA. This study offers an excellent opportunity to understand the risk of developing IPA in COVID-19 and find out whether fungal infection is contributing to the high death rate of COVID-19 patients in the ITU. An increased risk of IPA may not just apply to these two severe viral infections of the lung- it may also be that a heightened risk of secondary Aspergillus infection applies to any patient on the ICU with severe lung infection. In order to best understand this, we also plan to enrol patients on ICU with bacterial lung infection (pneumonia)as a control group so that we can compare the rates of IPA between patients with influenza, COVID19 and bacterial infections on the ICU infection.
This study will take place across seven hospital trusts during the 2019/2020, 2020/2021, and 2021/2022 and 2022/2023 influenza seasons. It will enrol adults admitted to Intensive Care with either severe influenza or COVID-19 as well a control group with bacterial lung infection (pneumonia). The proportion thathave evidence of IPA using routine diagnostic samples sent to the laboratory will be analysed. Clinical information will be recorded and analysed to identify any
factors that increase the IPA.
Ventilated patients with severe lung infection often have a procedure called a bronchoscopy where a small camera is used to look inside the lungs and flush through a small volume of fluid (bronchoalveolar lavage, BAL) to send to the local Microbiology laboratory to diagnose the cause of the infection.
Following informed consent, this study will store surplus BAL samples from patients, and later use them to evaluate lateral flow tests for Aspergillus. These tests are very quick and have the potential, if found to be useful, to be incorporated into clinical guidelines to make the diagnosis of IPA in ICU much easier. As well as left-over BAL samples, blood samples from patients will also be stored for later immune and immunogenetic studies, to help us understand why certain
patients with influenza or COVID-19 might be at greater risk of developing IPA.
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:
2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37657925/ (added 13/02/2024)
You can take part if:
Current inclusion criteria as of 13/01/2022:
1. Adults > 18 years
2. Admitted to ICU for respiratory support requiring intubation and ventilation for >24h
AND EITHER:
3. Positive influenza or SARS-CoV-2 PCR from nasal, throat swab, BAL or other respiratory specimen taken either < 7 days pre, or < 3 days post, admission to ICU
OR
4. Influenza or SARS-CoV-2 suspected but PCR results awaited – under these circumstances the patient can be provisionally enrolled, but later excluded if no specimens taken within either < 7 days pre, or < 3 days post admission to ICU positive as above
OR
5. Clinically suspected bacterial lower respiratory tract infection with associated radiological changes (pneumonia) encompassing both community and hospital-acquired pneumonia diagnosed ≤72hrs prior to ICU admission or ≤48 hours after admission. These patients must not have tested positive for influenza or SARS-CoV-2 PCR during th
You may not be able to take part if:
1. Respiratory failure not the primary reason for ICU admission 2. History of proven/ probable invasive pulmonary aspergillosis
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Unfortunately, this study is not recruiting public volunteers at this time. This is because the research isn’t ready for volunteers yet or the researchers are directly identifying volunteers in certain areas or hospitals. Please do not contact the research team as they will not be able to respond. For more information about research in general, visit the Be Part of Research homepage.
The study is sponsored by St George’s University Hospitals NHS Foundation Trust and funded by Gilead Sciences.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 43440
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
