Inhale Work Package 3
The Impact of using FilmArray Pneumonia Panel Molecular Diagnostics for Hospital-Acquired and Ventilator-Associated Pneumonia on Antimicrobial Stewardship and Patient Outcomes in UK Critical Care: A Multicentre Randomised Controlled Trial.
University College London
Duration of Study in the UK
2 years, 1 months, 1 days
Severely ill hospital patients often develop lung and respiratory infections such as pneumonia. Such infections are life threatening and must be treated as soon as possible with antibiotics. It is well known that not all antibiotics are working as well as they used to, this is largely due to resistance of the bacteria that cause the infections and has been listed as a major public health concern by the UK Department of Health and many other countries around the world.\nCurrent practice in hospitals, when a patient is suspected of having a lung infection, is to send a sample of their sputum (spit and phlegm mixture collected from their airways) to the microbiology lab for analysis. This takes 2-3 days, during that time the suspected infection is treated with a broad range of antibiotics. It has been found that this approach means around 67% of people with pneumonia receive antibiotics that they do not need, thus creating resistance risk and can cause unnecessary and unpleasant side effects to the patients themselves. \nThe INHALE trial tests a rapid diagnostic machine (the Biofire “FilmArray“) to see if sample results can be provided quicker than lab sample testing and if this leads to the best and most appropriate antibiotics being prescribed sooner. All participants will have their sample sent to the lab regardless of whether it is also tested on the new machine, so all standard care options are also available to their doctor. Half of participants will have a portion of their standard care sample tested on the machine straight away. Machine results should be available and reviewed within 8 hours of collection. To guide doctors in prescribing the most appropriate antibiotic according to resistance ’stewardship’ guidelines, trial specific guidance will also be provided. COVID-19 amendment – 06/04/2020 Owing to the current and anticipated pressures on ICUs as a result of the Covid-19 pandemic, randomisation was suspended on 16 March 2020. Follow-up on all randomised patients will continue as far as Covid-19 allows, with all protocol deviations documented. We anticipate that randomisation will re-commence as soon as the Covid-19 situation has stabilised and ICUs have reverted to a more normal patient mix. n the interim, whilst INHALE is paused, staff at several participating ICUs have indicated that test results from the Pneumonia Panel could prove extremely useful in the management of Covid-19 patients who would otherwise be treated with empirical broad-spectrum antibiotics to provide cover for possible secondary bacterial pneumonias, and have requested access to machines and reagents, which do have current CE-IVD authorisation for clinical use. To accommodate this, and to maximise clinical potential, we propose an observational study conducted in current INHALE sites to allow evaluation of the clinical utility of the tests. This would be distinct from the INHALE RCT, would provide useful data for patient and antibiotic management during the Covid-19 epidemic, and would allow sites to remain open and engaged, ready to re-commence randomisation to the RCT at the appropriate time. Accordingly, the objective of the study is to describe the clinical utility of rapid Pneumonia Panel testing on management of ICU patients during the Covid-19 outbreak. \n\nCOVID-19 amendment – 15/04/2020\n\nWe are seeking approval for a substantial amendment for the above listed study to include the retrieval of additional clinically relevant data from electronic patient records. The infrastructure is now successfully set up to collate the image and clinical datasets. However, to enable appropriate clinical metadata collection on echocardiograms within the dataset that have been performed during the current global health situation related to coronavirus, we want to make some amendments to the protocol. These will specifically ensure the study is able to correlate echocardiographic findings with specific diagnoses and cardiac outcomes relevant to COVID-19 positive patients undergoing clinical echocardiography scans within the hospital trust as well as other patients with other aetiologies of acute respiratory disease syndrome. There is no additional cost implication of this additional data acquisition. We have also updated the investigator list in the protocol to reflect the key clinical personnel involved with this particular disease and clinical care setting. To summarise, we have introduced changes to the protocol and changes to the document as outlined below: \n• Include the retrieval of clinically relevant data from patient electronic records to establish diagnosis including within an intensive care setting. \n• Updates to investigator list. Add a secondary objective to identify specific characteristics seen in echocardiograms performed in novel patient disease clusters.
London - Brighton & Sussex Research Ethics Committee
Date of REC Opinion
20 Mar 2019