Extrait

Background and study aims An acute respiratory infection (ARI) is a serious infection of the sinuses, throat, airways or lungs that prevents normal breathing function. Pathogens (viruses/bacteria) causing ARI are among the most likely candidates to cause the next pandemic. We need to better understand why some people become much more ill than others when they have an ARI. The elderly, people with chronic lung, heart or metabolic disease or immunocompromised (weakened immune system) patients are known to be at risk of developing severe disease. However, some respiratory infections can also cause severe disease in younger previously healthy individuals due to a combination of the virus itself and the individual’s immune responses. It is likely that individual risk factors affect the body’s response to ARI in different ways and this in turn can influence the severity of disease. Within broad risk groups it is currently not possible to predict which individuals are at increased risk of becoming severely ill. Consequently, there are no opportunities to tailor treatments. In people who become moderately or severely ill, there is an assumption that the body’s underlying response to disease is the same and hence that everyone will benefit equally from the same treatments. Increased insight into how different individuals respond to respiratory pathogens can allow us to better anticipate the severity of disease for a particular patient. This in turn will enable us to make strategies for individualized treatment options to reduce disease severity, risk of complications and hospitalisations. Who can participate? People aged over 18 attending primary and secondary care with mild to severe ARI. What does the study involve? Blood and respiratory (lung) samples will be collected from patients. We will analyse the samples to observe individual gene activity and we will compare samples from people with different risk factors for more severe disease. This will provide a detailed insight into how the body responds to infection and provide opportunities to understand the specific contributions of different risk factors. What are the possible benefits and risks of participating? There will be no direct benefit to participants. The study includes serial biological sampling which is in addition to that required for medical management. The results of the tests done on these samples may not contribute to improving the participant’s health. The results of this study will not be available in time to contribute to the patient’s care for this episode of ARI. This is an observational study and thus it is a very low-risk study. Participants will have three blood draws, which can be associated with pain at the draw site and rarely with infection. Respiratory swabs may be uncomfortable to obtain. Discomfort and risk will be minimized by using experienced clinical staff at each site. Participation in this research study poses a minimal risk of inconvenience through attendance of two follow-up visits. The risks are even lower for secondary care participants as the research sampling will be timed to coincide with routine clinical sampling which normally occurs daily in acutely unwell patients in hospital. Where is the study run from? Oxfordshire Primary Care Trust (UK). When is the study starting and how long is it expected to run for? From October 2015 to May 2018. Who is funding the study? European Commission. Who is the main contact? Emmanuelle Denis

Critère d'inclusion

• Acute respiratory infections

Liens

• ictrp
• isrctn