Clostridioides Difficile and Frailty

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

• Aarhus University Hospital

  collaborator OTHER

• Horsens Hospital

  collaborator OTHER

• Randers Regional Hospital

  collaborator OTHER

• Central Jutland Regional Hospital

  collaborator OTHER

• University of Aarhus

  lead OTHER

Principal Investigators

• Else Marie Damsgaard, Professor · Department of Geriatrics, Aarhus University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-09-16

Primary Completion

2023-08-16

Completion

2023-08-16

Countries

• Denmark

Study Locations