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.

INTERVENTION: The intervention in this study is the administration of intravenous dexamethasone (a type of steroid) 4mg twice daily for two days (4 doses total). The drug will be administered by registered nurses. Arm 1: 2/3 (53 people) will receive the study drug. Arm 2: 1/3 (27 people) will receive a placebo. A placebo is a medication that looks like the study medication (dexamethasone) but doesn't contain any active drug. The study drug will be mixed with sterile normal saline and administered as an infusion over 15 minutes. CONDITION: Parapneumonic effusion. PRIMARY OUTCOME: Time in hours taken to reach "clinical stability". This is defined as the time it takes for a participant to have all of their vital signs maintained within a certain range for at least 12 hours, or be well enough to be discharged home at the discretion of the treating doctor. Vital signs will be recorded every four hours in an observation chart by nursing staff. The observation chart will be reviewed every second day by the research team. SECONDARY OUTCOME: Adverse events e.g. development of hyperglycaemia assessed by testing capillary blood glucose 6 hourly until 24 hours post‐administration of the first dose of dexamethasone/placebo; evdence of inflammation or bleeding in the stomach, worsening infection, thrush and any other adverse events will be assessed by clinical assessment and review of hospital record. Change in C‐reactive protein based on serum assay. Change in percentage of the hemithorax that is obscured by effusion on chest x‐ray. Change in white cell count. White cell count will be measured on whole blood samples taken in edta‐containing tubes. Duration of antibiotic therapy as assessed from the medication record and discharge prescription. Length of hospital stay from commencement of treatment to discharge or death obtained from the hospital records and participant interview in the outpatient clinic. . Lung function measured using spirometry, specifically the forced expiratory volume and forced vital capacity in litres and as a percentage of the predicted volume. Overall survival will be assessed as the proportion of patients who are still alive at the Day 30 follow‐up appointment as assessed at review in outpatient clinic and/or from hospital records. ; INCLUSION CRITERIA: New pleural effusion on chest xray (confirmed using ultrasound at the bedside) with clinical evidence of pneumonia, as per the treating doctor's assessment, and no alternative cause identified. ; Physical activity patterns will be measured using a tri‐axial accelerometer (ActiGraph GT3X+). Accelerometers are objective measures of physical activity levels and sedentary time. Accelerometers are programmed to record raw data at a frequency of 30 Hz, which are reduced to vertical axis movement counts per 60‐second epoch. Cut off points used are: sedentary time = <100 counts/minute (cpm), light activity = 100‐1952 cpm and moderate and vigorous physical activity (MVPA) = >1952 cpm. Proportion of participants who have a normal white cell count (White cell count <11 x 10 9/litre will be considered normal for this study). Proportion of participants who require a pleural procedure (therapeutic thoracentesis, intercostal catheter insertion, pleuroscopy, video‐assisted thoracic surgery, intrapleural fibrinolytic/deoxyribonuclease therapy) as assessed by clinical examination by the research team every second day and from medical records. Proportion of participants with resolution of the pleural effusion on chest x‐ray. Proportion of patients with a normal C‐reactive protein (less than 5mg/dL) / blood test. Quality of Life (QoL) will be measured using a validated instrument: EQ‐5D‐5L is a standardised measure of HRQoL that comprises five dimensions including mobility, self‐care, usual activities, pain//discomfort and anxiety/depression.