Early geriatric assessment and management in older patients with Clostridioides difficile infection in Denmark (CLODIfrail): a randomised trial

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Clostridioides difficile infection causes diarrhoea and colitis. Older patients with Cdifficile infection are often frail and have comorbidities, leading to high mortality rates. The frailty burden in older people might restrict access to treatments, such as Cdifficile infection-specific antibiotics and faecal microbiota transplantation. We aimed to investigate the clinical effects of early comprehensive geriatric assessment (CGA) and frailty evaluation, including home visits and assessment for faecal microbiota transplantation, in older patients with Cdifficile infection. In this randomised, quality improvement trial with a pragmatic design, patients from the Central Denmark Region aged 70years or older with a positive PCR test for Cdifficile toxin were randomly assigned (1:1) to CGA or standard care, both with equal access to faecal microbiota transplantation. Patients and investigators were unmasked to treatment. The primary outcome was 90-day mortality, and was compared in the study groups according to the intention-to-treat principle. The study is registered with ClinicalTrials.gov, NCT05447533. Between Sept 1, 2022, and May 3, 2023, we randomly assigned 217patients to CGA (n=109) or standard care (n=108). The median patient age was 78years (IQR 74-84). 116 (53%) of 217patients were female and 101 (47%) were male. 16 (15%; 95% CI 9-23) of 109patients in the CGA group and 22 (20%; 14-29) of 108patients in the standard-care group died within 90days (odds ratio 0·66, 95% CI 0·32-1·38. No serious adverse events or deaths related to patient assessment or faecal microbiota transplantation were recorded in either group. Deaths directly attributable to Cdifficile infection were lower in the CGA group (seven [44%] of 16deaths vs 18 [82%] of 22deaths in the standard-care group; p=0·020). Older patients who received CGA had a 90-day mortality rate similar to that of patients who received standard care, but with fewer deaths directly attributable to Cdifficile infection. Innovation Fund Denmark, Novo Nordisk Foundation, and Helsefonden.