Clostridioides Difficile and Frailty (CLODIFRAIL)

University of Aarhus

Status: Completed

Conditions: Geriatric Assessment; Faecal Microbiota Transplantation; Aged; Frail Elderly; Clostridioides Difficile

Treatments: Other: Comprehensive geriatric assessment (CGA); Other: Continued geriatric care; Other: Standard care; Other: Faecal microbiota transplantation (FMT)

Study type: Interventional

Funder types: Other

Identifiers

NCT05447533

1106

Details and patient eligibility

About

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.

Full 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.

Enrollment: 217 patients

Sex: All

Ages: 70+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Patients aged ≥ 70 years and living in the Central Denmark Region
2. Positive PCR test Clostridioides difficile

Exclusion criteria

1. Previously included
2. > 4 episodes of CDI
3. FMT treatment 8 weeks before date of positive PCR test for Clostridioides difficile.
4. End of life care defined as follows: end of life care treatment has been initiated before positive PCR test for CDI and the patient has days/few weeks of survival (investigator consensus based on review of electronic medical journal (EMR))
5. Patients already received Comprehensive Geriatric Assessment, defined as follows: when diagnosed with CDI affiliated with the Department of Geriatrics (in- or outpatient activity).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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217 participants in 2 patient groups

Geriatric tailored assessment and intervention

Other group

Description:

The geriatric tailored intervention consists of the following components: 1. Comprehensive Geriatric Assessment 2. Continued geriatric care during 8 weeks follow-up or until cured.

Treatment:

Other: Faecal microbiota transplantation (FMT)

Other: Comprehensive geriatric assessment (CGA)

Other: Continued geriatric care

Standard care

Active Comparator group

Description:

Standard care: Patients are not contacted by the geriatric team. They receive usual treatment at the treating physician's discretion. Standard care of Clostridioides difficile infection in Denmark is described in the National clinical guideline.

Treatment:

Other: Standard care