Clostridioides Difficile and Frailty

NACompletedINTERVENTIONAL
Enrollment

217

Participants

Timeline

Start Date

September 16, 2022

Primary Completion Date

August 16, 2023

Study Completion Date

August 16, 2023

Conditions
Frail ElderlyClostridioides DifficileGeriatric AssessmentFaecal Microbiota TransplantationAged
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.

Trial Locations (1)

8220

Department of Geriatrics, Aarhus University Hospital, Aarhus

All Listed Sponsors
collaborator

Aarhus University Hospital

OTHER

collaborator

Horsens Hospital

OTHER

collaborator

Randers Regional Hospital

OTHER

collaborator

Central Jutland Regional Hospital

OTHER

lead

University of Aarhus

OTHER