The Steroid Therapy and Outcome of Parapneumonic Pleural Effusions (STOPPE): A Pilot Randomized Trial.
Fitzgerald DB., Waterer GW., Budgeon C., Shrestha R., Fysh ET., Muruganandan S., Stanley C., Saghaie T., Badiei A., Sidhu C., Harryanto H., Duong V., Azzopardi M., Manners D., Lan NSH., Popowicz ND., Peddle-McIntyre CJ., Rahman NM., Read CA., Tan AL., Gan SK., Murray K., Lee YCG.
RationalePleural effusion commonly complicates community-acquired pneumonia (CAP) and is associated with intense pleural inflammation. Whether anti-inflammatory treatment with corticosteroids improves outcomes is unknown.ObjectivesTo assess the effects of corticosteroids in an adult population with pneumonia-related pleural effusion.MethodsSTOPPE was a pilot, multicenter, double-blinded, placebo-controlled randomized trial involving six Australian centers. CAP patients with pleural effusion were randomized (2:1) to intravenous dexamethasone (4mg twice daily for 48 hours) or placebo and followed for 30 days. Given the diverse effects of corticosteroids, a comprehensive range of clinical, serological, and imaging outcomes were assessed in this pilot trial (ACTRN12618000947202).Results80 patients were randomized (1 withdrawn before treatment) and received dexamethasone (n=51) or placebo (n=28). This pilot trial found no preliminary evidence of benefits of dexamethasone in improving time to sustained (>12 hours) normalization of vital signs (temperature, oxygen saturations, blood pressure, heart, and respiratory rates): median 41·0 [95%CI 32·3-54·5] vs 27·8 [15·4-49·5] hours in the placebo arm, HR 0·729 [95%CI 0·453-1·173], p=0·193. Similarly, no differences in C-reactive protein or leukocyte counts were observed except for a higher leukocyte count in the dexamethasone group at Day 3. Pleural drainage procedures were performed in 49·0% of dexamethasone-treated and 42·9% of placebo-treated patients, p=0·60. Radiographic pleural opacification decreased over time with no consistent inter-group differences. Mean duration of antibiotic therapy (22·4 [SD=15·4] vs 20·4 [SD=13·8] days) and median hospitalization (6·0 [IQR=5·0-10·0] vs 5·5 [IQR=5·0-8·0] days) were similar between the dexamethasone and placebo groups. Serious adverse events occurred in 25·5% of dexamethasone-treated and 21·4% of placebo-treated patients. Transient hyperglycemia more commonly affected the dexamethasone group (15·6% vs 7·1%).ConclusionsSystemic corticosteroids showed no preliminary benefits in adults with parapneumonic effusions. Clinical trial registration available at https://anzctr.org.au/, ID: ACTRN12618000947202.