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Completed

NCT Number: NCT05447533

Clostridioides Difficile and Frailty

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.

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Key information

Conditions

Frail Elderly Aged Clostridioides Difficile Faecal Microbiota Transplantation Geriatric Assessment

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Geriatrics, Aarhus University Hospital

Aarhus, 8220, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Previously included
  • > 4 episodes of CDI
  • FMT treatment 8 weeks before date of positive PCR test for Clostridioides difficile.
  • 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))
  • Patients already received Comprehensive Geriatric Assessment, defined as follows: when diagnosed with CDI affiliated with the Department of Geriatrics (in- or outpatient activity).

Treatment and study plan

comprehensive geriatric assessment (CGA)

Other

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:

  • Severe index, recurrent or refractory CDI as defined by national clinical guidelines or
  • 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

Other

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)

Other

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

Other

Standard care: Patients are not contacted by the geriatric team. They receive usual treatment at the treating physician's discretion.

Primary outcomes

  1. 90-day mortality

    Time frame: 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 outcomes

  1. Physical functional status

    Time frame: 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.

  2. Overall quality of life assessed by Depression List

    Time frame: 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.

  3. Quality of life assessed by the 5-level EQ-5D Interviewer version

    Time frame: 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.

  4. Quality of life assessed by the 5-level EQ-5D proxy 2 version

    Time frame: 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.

Other outcomes

  1. Recurrent Clostridioides difficile infection

    Time frame: Within period of 90-day follow-up from date of positive PCR test for Clostridioides difficile.

    Recurrent CDI is defined as a new CDI episode after ended treatment for CDI with treatment response. New episode of diarrhea (≥3 loose stools, Bristol 6-7) and a positive Clostridioides difficile PCR test. Outcome will be collected from electronic medical journals.

  2. Time to Faecal microbiota transplantation

    Time frame: Within period of 90-day follow-up.

    Time from date of positive PCR test for Clostridioides difficile to date of faecal microbiota transplantation.

  3. Time to initiation of vancomycin/bactocin treatment

    Time frame: Within period of 90-day follow-up.

    Time from positive PCR test for Clostridioides difficile to date of initiation of medical treatment with vancomycin/bactocin.

  4. Readmission in patients diagnosed with Clostridioides difficile during hospitalisation

    Time frame: Within a period of 30 days after hospital discharge.

    Readmission defined as any unplanned, acute rehospitalisation (elective or planned admissions and outpatient procedures excluded) at any hospital within the Central Denmark Region, occurring within four hours from index admission and up to 30 days after hospital discharge.

  5. Days in hospital

    Time frame: Within period of 90-day follow-up after positive PCR test for CD.

    Number of days in hospital from date of positive PCR test for CD and until 90 days.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital
  • Central Jutland Regional Hospital
  • Horsens Hospital
  • Randers Regional Hospital

Registry information

Official study title

Frail Old Patients With Clostridioides Difficile Infection: Improvement of Quality in Treatment and Care

Acronym: CLODIFRAIL

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 7, 2022
Registry last updated
Aug 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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