Clostridioides difficile infection in frail older patients, quality in treatment and care: the CLODIFRAIL study protocol for a multicentre randomised controlled trial

Abstract

Abstract Background: Clostridioides difficile infection (CDI) is complex and associated with adverse clinical outcomes in older patients, including increased mortality rates. Effective transition of care for patients with CDI is critical to improve survival and health outcomes and to reduce recurrence rates. The aim of this study is to investigate the effects of a geriatric tailored intervention for older patients with CDI on patient survival, compared with older patients with CDI who receive usual care. Methods: This is a quality improvement study, comparing two organisational pathways. We include 216 patients aged 70 years or more and diagnosed with CDI. Patients with a positive Clostridioides difficiletoxin PCR test are randomised 1:1 to either 1) a geriatric tailored assessment and intervention (the CLODIFRAIL intervention) or 2) usual care at the treating physician’s discretion. The intervention consists of three main parts: 1) a clinical geriatric assessment; 2) a clinical evaluation of indication for and treatment with faecal microbiota transplantation (FMT); 3) weekly clinical assessments during eight weeks. The follow-up period is 90 days. The primary outcome is 90-day survival from the date of positive CDI PCR test. Patient-related secondary outcome measures include quality of life measured by EQ-5D-5L and by the Overall Quality of Life Depression List (OQoL-DL) and functional status measured by the Functional Recovery Score (FRS). Quality-related secondary outcome measures include time-to-treatment with FMT, time-to-treatment with vancomycin, CDI recurrence, readmission, and days in hospital. Discussion: This study will provide new knowledge on the effects of a geriatric tailored intervention for older patients with CDI, including an early assessment of the indication for FMT. Trial registration: The study was pre-registered at ClinicalTrials.gov on 28 June, 2022. Study identifier: NCT05447533.