A Pragmatic Trial of Glucocorticoids for Community-Acquired Pneumonia

N Engl J Med. 2025 Dec 4;393(22):2187-2197. doi: 10.1056/NEJMoa2507100. Epub 2025 Oct 29.

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.).

Publication types

  • Clinical Trial, Phase IV
  • Multicenter Study
  • Pragmatic Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Administration, Oral
  • Adult
  • Aged
  • Community-Acquired Pneumonia* / diagnosis
  • Community-Acquired Pneumonia* / drug therapy
  • Community-Acquired Pneumonia* / mortality
  • Female
  • Glucocorticoids* / administration & dosage
  • Glucocorticoids* / adverse effects
  • Humans
  • Kaplan-Meier Estimate
  • Kenya / epidemiology
  • Male
  • Middle Aged
  • Severity of Illness Index
  • Treatment Outcome

Substances

  • Glucocorticoids

Associated data

  • ISRCTN/ISRCTN36138594