Clostridioides Difficile and Frailty

Not Applicable

Completed

• Conditions: Geriatric Assessment; Aged; Frail Elderly; Clostridioides Difficile; Faecal Microbiota Transplantation
• Interventions: Other: Comprehensive geriatric assessment (CGA); Other: Standard care; Other: Continued geriatric care; Other: Faecal microbiota transplantation (FMT)

• Registration Number: NCT05447533
• Lead Sponsor: University of Aarhus

Brief 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.

Study Timeline

• Study First Submitted: 2022-06-28
• Study First Submitted QC: 2022-07-01
• Study First Posted: 2022-07-07
• Study Start: 2022-09-16
• Status Verified: 2023-05
• Primary Completion: 2023-08-16
• Study Completion: 2023-08-16
• Last Update Submitted: 2023-08-16
• Last Update Posted: 2023-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 217

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Geriatric tailored assessment and intervention	Comprehensive geriatric assessment (CGA)	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.
Geriatric tailored assessment and intervention	Faecal microbiota transplantation (FMT)	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.
Standard care	Standard care	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.
Geriatric tailored assessment and intervention	Continued geriatric care	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.

Primary Outcome Measures

Name	Time	Method
90-day mortality	Date of 90-day follow-up will include day of positive PCR test for CD and day 90 from date of positive PCR test for CD.	Mortality within 90 days from date of positive Polymerase Chain Reaction (PCR) test for Clostridioides difficile (CD). Date of death will be collected from the electronic medical journals according to date of death registration.

Secondary Outcome Measures

Name	Time	Method
Physical functional status	83-97 weekdays after date of positive PCR test for Clostridioides difficile.	Functional Recovery Score (FRS). Sum-score, range 100-0 (100 is the highest physical functional status score possible, 0 is the lowest).; FRS will be performed on both groups by a blinded and trained project assessor during planned visits to the patients at 90-days follow-up. FRS will be performed according to the functional capacity at 90-day of follow-up as well as a retrospective FRS assessment according to functional capacity on the date of positive PCR test for Clostridioides difficile.; This will be performed by asking the patient/relatives about the functional capacity. FRS will be performed within 83-97 weekdays after date of positive PCR test for Clostridioides difficile.
Overall quality of life assessed by Depression List	83-97 weekdays after date of positive PCR test for Clostridioides difficile.	The Overall quality of life will be assessed by the Overall Quality of Life Depression List (OQoL-DL) and will be performed on both groups by a blinded and trained project assessor during planned visits to the patients at 90-days follow-up within 83-97 weekdays after date of positive PCR test for Clostridioides difficile.
Quality of life assessed by the 5-level EQ-5D Interviewer version	83-97 weekdays after date of positive PCR test for Clostridioides difficile.	The quality of life will be assessed by the 5-level EQ-5D version (EQ-5D-5L). The EQ-5D-5L be performed on both groups by a blinded and trained project assessor during planned visits to the patients at 90-days follow-up within 83-97 weekdays after date of positive PCR test for Clostridioides difficile.
Quality of life assessed by the 5-level EQ-5D proxy 2 version	83-97 weekdays after date of positive PCR test for Clostridioides difficile.	The quality of life will be assessed by the 5-level EQ-5D proxy 2 version (EQ-5D-5L). The EQ-5D-5L proxy 2 version be performed in both groups by proxy invited online. The significant others (proxy) will receive the survey at 90-days follow-up within 83-97 weekdays after date of positive PCR test for Clostridioides difficile.

Trial Locations

Locations (1)

Department of Geriatrics, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark