A Pragmatic Trial of Glucocorticoids for Community-Acquired Pneumonia
Ruth Lucinde, Henry Gathuri, Paul Mwaniki, Benedict Orindi, Edwin Onyango Otieno, Stella Mwakio, Lillian Mulemi, Lynda Isaaka, Jimmy Shangala, Metrine Saisi, Elizabeth Isinde, Irene Njeri Oginga, Alvin Wachira, Evans Manuthu, Hazel Kariuki, Patrick Asaava, Jared Nyikuli, Cyprian Wekesa, Amos Otedo, Hannah Bosire, Steve Biko Okoth, Winston Ongalo, David Mukabi, Wilberforce Lusamba, Beatrice Muthui, Isaac Adembesa, Caroline Mithi, Mohammed Sood, Nadia Aliyan, Bernard Gituma, Matiko G. Matiko, Charles Omondi, Loice Achieng Ombajo, Nicholas Kirui, Lucy Ochola, Abdirahman I. Abdi, E. Wangeci Kagucia, Mike English, Mainga Hamaluba, Isabella Ochola-Oyier, Dorcas Kamuya, Philip Bejon, Edwine Barasa, Ambrose Agweyu, Samuel Akech, Anthony Etyang
Abstract
BACKGROUND: Adjunctive glucocorticoids may reduce mortality among patients with severe community-acquired pneumonia (CAP) in well-resourced settings. Whether these drugs are beneficial in low-resource settings with limited diagnostic and treatment facilities is unclear. METHODS: In this pragmatic, open-label, randomized, controlled trial conducted in 18 public hospitals in Kenya, we assigned adult patients who had received a diagnosis of CAP and who did not have a clear indication for glucocorticoids to receive either standard care for CAP or oral low-dose glucocorticoids for 10 days in addition to standard care. The primary outcome was death from any cause at 30 days after enrollment. RESULTS: A total of 2180 patients underwent randomization (1089 assigned to the glucocorticoid group and 1091 to the standard-care group). The median age of the patients was 53 years (interquartile range, 38 to 72); 46% were women. At day 30, deaths were reported in 530 patients (24.3%): 246 patients (22.6%) in the glucocorticoid group and 284 patients (26.0%) in the standard-care group (hazard ratio, 0.84; 95% confidence interval, 0.73 to 0.97; P = 0.02). The frequencies of adverse events and serious adverse events were similar in the two trial groups. Serious adverse events that were considered to be related to glucocorticoid administration occurred in 5 patients (0.5%). CONCLUSIONS: In patients with CAP in a low-resource setting, adjunctive glucocorticoid therapy was associated with a lower risk of death than standard care. (Funded by Wellcome Trust and others; SONIA PACTR number, PACTR202111481740832; ISRCTN number, ISRCTN36138594.).