Clostridioides Difficile and Frailty — CLODIFRAIL  

Aged Clinical Trial

Official title: Frail Old Patients With Clostridioides Difficile Infection: Improvement of Quality in Treatment and Care

Status Completed

Clinical Trial Summary

CDI is a major cause of antibiotics-associated diarrhoea. More than half of the patients affected are 70 years or older and frail. Mortality among older patients with CDI is high. Faecal microbiota transplantation (FMT) is a life-saving therapy which reduce symptom duration and mortality. The FMT procedure usually requires hospital attendance, and frail old patients often are too weak to tolerate transportation to hospital and may therefore be withheld treatment.

The overall aim of the present project is to investigate whether a multimodal geriatric assessment, treatment and follow-up of frail older patients with CDI can improve patient survival compared with standard care. In particular, it is explored whether an expanded collaboration between the geriatric wards, early clinical assessment and home treatment with FMT contribute to increased patient survival rates.

Clinical Trial Description

This is a multi-centre randomised clinical trial that test two established care pathways in the assessment and treatment of old patients with Clostridioides difficile infection (CDI). We aim to include 216 patients aged 70 years or older with Clostridioides difficile infection. Patients are randomised in a 1:1 ratio to either geriatric tailored intervention or standard care as defined by national clinical guidelines. The primary outcome is 90-day survival. ;

Related Conditions & MeSH terms

• Aged
• Faecal Microbiota Transplantation
• Frail Elderly
• Geriatric Assessment

• NCT number: NCT05447533
• Study type: Interventional
• Source: University of Aarhus
• Status: Completed
• Phase: N/A
• Start date: September 16, 2022
• Completion date: August 16, 2023