Extrait

Background and study aims This observational study aims to determine the capacity of baseline clinical and biological parameters and an associated prediction model (RAPID score) to predict mortality from pleural infection (infection of the membrane that enfolds the lungs). Who can participate? Patients diagnosed with a pleural infection will be invited to participate. What does the study involve? This study has been specifically designed to collect clinical and biological data - for example, the results of blood tests and pleural fluid analysis, and physical observations such as blood pressure, chest X-rays, chest ultrasound scans, lung function testing - in patients with diagnosed pleural infection. We hope that by analysing these results a diagnostic tool (or prediction score) can be developed that will help doctors in the future identify which patients with pleural infection are at higher or lower risk of serious problems or complications. This will hopefully help doctors choose the best treatment options for their patients. What are the possible benefits and risks of participating? We hope that every patient in the study will benefit, as normal, from the treatment they receive for their pleural infection as well as the opportunity for regular and continued follow-up appointments and assessments. Participation in the study will not however entitle patients to receive any specific or specialist treatment that they might not otherwise have access to. When the study is completed, we hope that the information collected from those individuals who choose to participate will help us to improve the treatment of patients with pleural infection in the future. Pleural infection itself and the different methods of treating it have their own associated risks and complications, but none of these are affected by participation in this study. Patients will have at least three chest x-rays during their participation, although many of these would need to be done whether you were in the study or not. There are some theoretical health risks from excessive radiation exposure, but chest x-rays are considered one of the safest tests as the dose from one is only equivalent to around four days' worth of normal background radiation. Where is the study run from? The study is being led and co-ordinated by the Oxford Respiratory Trials Unit based at the Churchill Hospital, Oxford, United Kingdom. When is the study starting and how long is it expected to run for? In total, 500/600 patients from hospitals around the world will participate in this study over an approximate three year period starting in 2013. Who is funding the study? Medical Research Council (UK). Who is the main contact? Mrs Emma Hedley [email protected]

Critère d'inclusion

• Pleural infection

Liens

• ictrp
• isrctn