Steroid Therapy and Outcome in Parapneumonic Pleural Effusion (STOPPE): A randomised double-blind placebo-controlled trial of intravenous steroid in the management of parapneumonic pleural effusion.

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The lung and the inside of the chest wall are both covered by a thin lining called the pleura, which produces a very small amount of fluid to lubricate the lung during normal breathing. Pneumonia can cause a build-up of fluid in between the pleural linings called a parapneumonic pleural effusion. In many cases, the effusion clears up with antibiotics; less commonly, a chest tube is required to drain the fluid. Steroids are anti-inflammatory medications that have been used for many years in the management of many medical conditions such as rheumatoid arthritis and asthma. In certain serious infections, inflammation is thought to be the cause of some of the symptoms, and steroids have been used to reduce these effects. Steroids have been used in people with pneumonia in the past with some success, and importantly, few side effects. There is some evidence to suggest that parapneumonic pleural effusions occur because of excessive inflammation, which may delay recovery. A recent study in children showed that patients with a parapneumonic effusion recovered faster if they were treated with steroids in addition to antibiotics. In this study, we aim to assess whether administering steroids to adults with a parapneumonic effusion will speed up their recovery from the illness. Study participants will receive 4 doses of steroid or a placebo over 48 hours. A placebo is a medication that looks the same as the steroid but doesn't contain any active drug. This study will be "double-blind" which means that neither the participant, nor the doctor, will know which treatment is administered until the end of the study. It is a randomised clinical trial which means that each participant will be put in one of the study groups (to receive the active drug or placebo) by chance and will not be able to choose their treatment. Two-thirds of participants will receive the study drug and one third will receive placebo. The 48 hour treatment course is considered to be short, which means that there is much less likelihood of any side effects. The main side effect of steroids is high glucose levels in the blood, which typically go back to normal once the treatment is stopped. Other possible side effects include inflammation/bleeding in the stomach, suppression of the immune system and worsening infection, oral thrush and mood disturbance. In studies that have been done so far, none of these were more common in the group treated with steroids compared to those who weren’t. The outcomes that we will assess to compare the two groups will include the time to recovery from the illness, changes in blood tests and chest x-rays over time, duration of antibiotic therapy and length of stay in hospital, need for a procedure to drain the fluid, quality of life over the 30 days post-treatment, adverse events (side effects of treatments) and overall survival. The data collected will be analysed by a statistician.