A pragmatic randomized controlled trial of standard care versus steroids plus standard care for treatment of pneumonia in adults admitted to Kenyan hospitals (SONIA)

Abstract

Background: It is unclear if adjunctive steroid therapy reduces mortality in community-acquired pneumonia, as very few studies have had mortality as a primary outcome. This question has become even more relevant following demonstration of a mortality benefit of dexamethasone when used in patients with COVID-19 who had severe disease. This has led to increased prescription of steroids in adults with community acquired pneumonia in low-resource settings even when their COVID-19 diagnosis is uncertain due to low testing rates. This pragmatic parallel randomised-controlled open-label trial will determine if adjunctive low-dose steroids for treatment of adults admitted to hospital with community acquired pneumonia whose SARS-CoV-2 status is either unknown or negative reduces mortality. Methods: We will enroll and randomize 2180 patients admitted with a clinical diagnosis of community acquired pneumonia into two arms; in Stratum A-participants will receive standard care for the treatment of community acquired pneumonia. In Stratum B-participants will receive a 10-day course of low-dose oral corticosteroids in addition to standard care. All participants will be followed up to 30 days post randomization and their final status recorded (alive or dead). An immunology sub study will be conducted on a subset of the trial participants (50 per arm) to determine the correlation of pre-existing and treatment induced immune and metabolic changes with study outcomes. Discussion: Mortality among adults admitted to hospital with community acquired pneumonia in resource-limited settings is high. Steroids are readily available in these settings. If the addition of steroids to standard care for community acquired pneumonia is found to be beneficial, this easily scalable intervention would significantly reduce the currently high mortality associated with the illness.