217
Participants
Start Date
September 16, 2022
Primary Completion Date
August 16, 2023
Study Completion Date
August 16, 2023
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)."
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."
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.
Standard care
Standard care: Patients are not contacted by the geriatric team. They receive usual treatment at the treating physician's discretion.
Department of Geriatrics, Aarhus University Hospital, Aarhus
Aarhus University Hospital
OTHER
Horsens Hospital
OTHER
Randers Regional Hospital
OTHER
Central Jutland Regional Hospital
OTHER
University of Aarhus
OTHER