The Steroid Therapy and Outcome of Parapneumonic Pleural Effusions (STOPPE): A Pilot Randomized Trial

RATIONALE: Pleural effusion commonly complicates community-acquired pneumonia (CAP) and is associated with intense pleural inflammation. Whether anti-inflammatory treatment with corticosteroids improves outcomes is unknown.

OBJECTIVES: To assess the effects of corticosteroids in an adult population with pneumonia-related pleural effusion.

METHODS: STOPPE 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).

RESULTS: 80 patients were randomized (1 withdrawn before treatment) and received dexamethasone (n=51) or placebo (n=28).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%).

CONCLUSIONS: Systemic corticosteroids showed no preliminary benefits in adults with parapneumonic effusions. Clinical trial registration available at https://anzctr.org.au/, ID: ACTRN12618000947202.