A pragmatic randomized controlled trial of standard care versus corticosteroids plus standard care for treatment of pneumonia in adults admitted to Kenyan hospitals (SONIA) [version 2; peer review: 2 approved]

A pragmatic randomized controlled trial of standard care versus corticosteroids plus standard care for treatment of pneumonia in adults admitted to Kenyan hospitals (SONIA) [version 2; peer review: 2 approved]

Background Mortality among adults admitted to hospital with community acquired pneumonia in resource-limited settings is high. Recent studies conducted in high-income settings have demonstrated beneficial effects of low-dose corticosteroids in reducing mortality in patients with severe community acq...

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Main Authors: Isaac Adembesa, Mainga Hamaluba, Nicholas Kirui, Mohammed Sood, Samuel Akech, Caroline Mithi, Bernard Gituma, Nadia Ahmed, Matiko Giabe, Vera Bina Ongaki, Loice Achieng Ombajo, Charles Omondi, Anthony Oliwa Etyang, Wangeci Kagucia, Lynette Isabella Ochola-Oyier, Ambrose Agweyu, Philip Bejon, Benedict Orindi, Dorcas Kamuya, Mike English, Jimmy Shangala, Stella Mwakio, Abdirahman Abdi, Ruth Lucinde, Edwin Onyango, Henry Gathuri, Morris Ogero, Salome Chira, Irene Njeri Oginga, Lynda Isaaka, Evans Manuthu, Alvin Wachira, Jared Nyikuli, Hazel Kariuki, Amos Otedo, Cyprian Wekesa, Steve Biko Okoth, Hannah Bosire, David Mukabi, Winston Ongalo, Beatrice Muthui, Wilber Lusamba
Format: Article
Language:English
Published: Wellcome 2025-05-01
Series:Wellcome Open Research
Subjects:
Pragmatic
Randomized-Controlled Trial
Steroids
Pneumonia
Adults
Mortality
eng
Online Access:https://wellcomeopenresearch.org/articles/7-269/v2
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Summary:Background Mortality among adults admitted to hospital with community acquired pneumonia in resource-limited settings is high. Recent studies conducted in high-income settings have demonstrated beneficial effects of low-dose corticosteroids in reducing mortality in patients with severe community acquired pneumonia. It is unknown whether these findings apply to low-income settings such as sub-Saharan Africa. This pragmatic randomized-controlled open-label trial will determine the effect of adjunctive low-dose corticosteroids in the management of adults admitted to hospital with community acquired pneumonia on mortality 30-days post-randomization. Methods We will enroll and randomize 2180 patients admitted with a diagnosis of community acquired pneumonia into two arms: the control and intervention arm. Those in the control arm will receive standard care for the treatment of community acquired pneumonia i.e., combination therapy with a beta-lactam and macrolide antibiotic. Those in the intervention arm will receive up to 10-days treatment with 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). Discussion If adjunctive low-dose oral corticosteroids are found to be beneficial, this easily scalable intervention would significantly reduce the currently high mortality associated with community acquired pneumonia. Pan-African Clinical Trials Registry: PACTR202111481740832; ISRCTRN registry: ISRCTN36138594
ISSN:2398-502X

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