RCT Abstract - Effect of adjunct betamethasone vs placebo on time to clinical stabilisation upon hospital admission and risk of rehospitalisation in children with community-acquired pneumonia

<bold>Background:</bold> Adjunct steroids reduce mortality and may accelerate clinical stabilisation in adults with community-acquired pneumonia (CAP). Evidence in children is lacking. <bold>Objectives:</bold> To investigate whether adjunct oral corticosteroids in children hospitalised with CAP result in faster stabilisation (Co-primary effectiveness endpoint) while not being worse in terms of CAP-related readmission (Co-primary safety endpoint). <bold>Methods:</bold> This multicentre RCT enrolled children <14 years of age with clinical CAP at admission to 9 CH and 4 DE sites. Children were randomised to 2 days of oral betamethasone or placebo. Time to clinical stabilisation and CAP-related readmission were assessed through to week 4 (for safety: non-inferiority margin 7%; daily follow-up in hospital and at 1, 2 and 4 weeks by telephone). <bold>Results:</bold> We enrolled 510 children (Sep 2018 to Feb 2024), with 1 patient lost to follow-up. The median age was 34 months [IQR 19, 56]. 249 children were allocated to betamethasone and 260 to placebo. Patient characteristics were balanced between the trial arms. Median time to clinical stabilisation was 45.7 hours [95%CI 43.0, 57.8] in the betamethasone and 40.8 hours [95%CI 37.9, 45.0] in the placebo arm (logrank p = 0.671). With 18 and 14 CAP-related re-hospitalisations in the betamethasone and placebo arms, respectively, the risk difference was estimated at 1.8% [95% -2.8, 6.5]. <bold>Conclusion:</bold> While adjunct oral corticosteroids were non-inferior regarding CAP-related readmission, we did not observe faster clinical stabilisation. These results do not support the use of adjunct steroids in paediatric inpatient CAP.