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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.
HAP
FAST
hapfast@liverpool.ac.uk
Daniel
Wootton
dwootton@liverpool.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Influenza and pneumonia
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.
Hospital-Acquired Pneumonia (HAP) is a severe lung infection that develops while a patient is in hospital. We aim to design a trial to see if modern diagnostic investigations can safely improve outcomes for patients suspected of HAP.
Currently, doctors use chest x-rays to make the diagnosis, but these are difficult to interpret and a third of patients suspected of HAP receive antibiotics inappropriately. Patients are concerned about misdiagnosis and a solution might be to replace the chest x-ray with a CT scan since these show the lungs in more detail.
Once a diagnosis of HAP is made, doctors would like to identify the bacteria or viruses responsible. However, current tests are too slow to determine the initial treatment, so guidelines suggest we cover a range of possibilities with two extended spectrum antibiotics. Patients tell us they are concerned, because these antibiotics increase the risk of severe side effects and promote antibiotic resistance. The BIOFIRE® FILMARRAY® pneumonia panel (FAPP) is a new test that can identify the cause of HAP quickly. If we can determine the best way to use the FAPP, we can give antibiotics more effectively and slow the development of antimicrobial resistance.
We will conduct a feasibility study to inform the design of a fully powered trial to discover whether using CT scans or the FAPP, or both together, helps improve antibiotic use and patient recovery whilst being cost effective.
We will interview some participants and staff about how the trial is working so that we can improve the design. We will list the costs associated with HAP so we can design a cost effectiveness evaluation for the definitive trial. We will use patient samples to investigate immune and inflammation related processes to better understand why some people develop HAP and why some become particularly unwell.
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:
Interventional type: Device;Imaging;
You can take part if:
You may not be able to take part if:
HAP-FAST Pilot Sudy Any patient meeting any of the criteria listed below at randomisation will be excluded from study participation: - Already received a chest X-ray to confirm suspected HAP diagnosis - Intention to palliate rather than cure - Interventions cannot be completed before administration of second antibiotic dose* - Cannot be randomised to low-dose, non-contrast CT scan on clinical grounds e.g. strong suspicion of PE** - Pregnancy*** - Previous study participation (patients with second of third episodes of HAP will not be re-recruited) * In the circumstance where a patient is diagnosed with HAP whist receiving antibiotics for a non-respiratory infection e.g. cellulitis or UTI, if the HAP diagnosis leads to a change in the antibiotic prescription to cover the HAP then that patient will be eligible for recruitment however, if the diagnosis of HAP does not result in a change in antibiotic then the patient is not eligible. **A non-contrast, low-dose thoracic CT scan is an inappropriate test for a PE and if that is high in the differential diagnosis then tick yes here. ***A urine pregnancy test is required as part of routine care prior to a chest X-ray or CT scan. If the test reveals the patient is pregnant, they will not be eligible for the study as they will be unable to receive a CT scan as part of this study. Pregnancy tests are not required at future time points. A patient is not eligible to be entered into the 2nd randomisation if: - Following the CXR or CT the clinician decides not to treat with antibiotics for either HAP or a hospital acquired RTI. - A sputum sample cannot be obtained before the second dose of antibiotics is administered. Control group for mechanistic sub-study Not willing or able to provide 3 paired blood, sputum and nasal swab samples each > = 2 weeks apart • Patients taking the following drugs: o Long term oral steroid use (any dose) o Methotrexate o Cyclophosphamide o Anti-TNF drugs, Rituximab or other biological therapies • Exacerbation or infection requiring acute antibiotics and or oral steroids within the last 4 weeks* *If a patient exacerbates in between the three planned samples – e.g. between the first and second – then 4 weeks should elapse following completion of any treatments before any subsequent samples are taken i.e. patient should be at a self-reported baseline level of symptoms.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Daniel
Wootton
dwootton@liverpool.ac.uk
HAP
FAST
hapfast@liverpool.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by University of Liverpool and funded by NIHR Academy .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 54289
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