NCT05447533

Clostridioides Difficile and Frailty

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 217 (actual)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
OTHER	Comprehensive geriatric assessment (CGA)	Within 5 weekdays from date of randomization (not included) a standardized CGA with a tailor-made intervention will be performed in the allocated ward or at home by a geriatric team. Bedside Multidimensional Prognostic Index (MPI) will be performed. A geriatric Clostridioides difficile infection checklist will be performed by local geriatrician and secure an early assessment of CDI and treatment strategy. When indication: pre-treatment with vancomycin 125 mg x 4. Routine biochemical analyses for patients with Clostridioides difficile infection. Evaluation of indication for faecal microbiota transplantation (FMT). Criteria for FMT rely on the geriatric assessment and will be considered for the patient if the patient fulfil one of the following: 1. Severe index, recurrent or refractory CDI as defined by national clinical guidelines or 2. High risk patient according to CGA at first visit. High risk patient is defined frailty grade MPI-2 (moderate) or MPI-3 (severe).
OTHER	Continued geriatric care	Continued specialized geriatric care through 8 weeks of follow-up. Minimum of follow-up is 8 weeks from last FMT or start of vancomycin/fidaxomicin treatment. Tailormade telephone contacts and/or visits in case of clinical exacerbation. Performed by local geriatric teams. The geriatric department remains responsible for the CDI during 8 weeks of follow-up or until cured.
OTHER	Faecal microbiota transplantation (FMT)	When clinical indication for FMT, this will be delivered as 15-25 capsules (\~ 50 grams of donor faeces from one thoroughly screened healthy donor). If the patient is not admitted to hospital, FMT will be de-livered as home treatment via regional geriatric team or project manager and project nurse. If the patient has dysphagia diagnosed by dysphagia screening or carries a nasogastric tube, vancomycin and FMT can be delivered by naso-jejunal tube (Bengmark 10 Fr, Nutricia), requiring a referral to the Radiology department for verification of duodenal/jejunal tube placement. If available in the specific department, placement can be controlled via mobile x-ray.
OTHER	Standard care	Standard care: Patients are not contacted by the geriatric team. They receive usual treatment at the treating physician's discretion.

Timeline

• Start date: 2022-09-16
• Primary completion: 2023-08-16
• Completion: 2023-08-16
• First posted: 2022-07-07
• Last updated: 2023-08-18

Locations

1 site across 1 country: Denmark