Clinical trial NCT05447533: Clostridioides Difficile and Frailty
Official title: Frail Old Patients With Clostridioides Difficile Infection: Improvement of Quality in Treatment and Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frail Elderly
Clostridioides Difficile
Geriatric Assessment
Faecal Microbiota Transplantation
Aged
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Horsens Hospital
name: Randers Regional Hospital
name: Central Jutland Regional Hospital
First posted: 2022-07-07
Enrollment: 217
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel-group randomised clinical trial (RCT). The study compares two well-known organisations of care and does not involve experimental treatments or sampling of biological material outside of routine care. It is therefore classified as a quality improvement project by the Central Denmark Region Committees on Health Research Ethics (case number 1-10-72-1-21).
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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).

Primary outcomes:
measure: 90-day mortality
timeFrame: 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.
Secondary outcomes:
measure: Physical functional status
timeFrame: 83-97 weekdays after date of positive PCR test for Clostridioides difficile.
measure: Overall quality of life assessed by Depression List
timeFrame: 83-97 weekdays after date of positive PCR test for Clostridioides difficile.
measure: Quality of life assessed by the 5-level EQ-5D Interviewer version
timeFrame: 83-97 weekdays after date of positive PCR test for Clostridioides difficile.
measure: Quality of life assessed by the 5-level EQ-5D proxy 2 version
timeFrame: 83-97 weekdays after date of positive PCR test for Clostridioides difficile.
Other outcomes:
measure: Recurrent Clostridioides difficile infection
timeFrame: Within period of 90-day follow-up from date of positive PCR test for Clostridioides difficile.
measure: Time to Faecal microbiota transplantation
timeFrame: Within period of 90-day follow-up.
measure: Time to initiation of vancomycin/bactocin treatment
timeFrame: Within period of 90-day follow-up.
measure: Readmission in patients diagnosed with Clostridioides difficile during hospitalisation
timeFrame: Within a period of 30 days after hospital discharge.
measure: Days in hospital
timeFrame: Within period of 90-day follow-up after positive PCR test for CD.
Locations:
city: Aarhus
country: Denmark
facility: Department of Geriatrics, Aarhus University Hospital
Study officials:
affiliation: Department of Geriatrics, Aarhus University Hospital
name: Else Marie Damsgaard, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bauer MP, Notermans DW, van Benthem BH, Brazier JS, Wilcox MH, Rupnik M, Monnet DL, van Dissel JT, Kuijper EJ; ECDIS Study Group. Clostridium difficile infection in Europe: a hospital-based survey. Lancet. 2011 Jan 1;377(9759):63-73. doi: 10.1016/S0140-6736(10)61266-4.
citation: Czepiel J, Krutova M, Mizrahi A, Khanafer N, Enoch DA, Patyi M, Deptula A, Agodi A, Nuvials X, Pituch H, Wojcik-Bugajska M, Filipczak-Bryniarska I, Brzozowski B, Krzanowski M, Konturek K, Fedewicz M, Michalak M, Monpierre L, Vanhems P, Gouliouris T, Jurczyszyn A, Goldman-Mazur S, Wultanska D, Kuijper EJ, Skupien J, Biesiada G, Garlicki A. Mortality Following Clostridioides difficile Infection in Europe: A Retrospective Multicenter Case-Control Study. Antibiotics (Basel). 2021 Mar 13;10(3):299. doi: 10.3390/antibiotics10030299.
citation: Cober ED, Malani PN. Clostridium difficile infection in the "oldest" old: clinical outcomes in patients aged 80 and older. J Am Geriatr Soc. 2009 Apr;57(4):659-62. doi: 10.1111/j.1532-5415.2009.02182.x.
citation: Hensgens MP, Goorhuis A, Dekkers OM, van Benthem BH, Kuijper EJ. All-cause and disease-specific mortality in hospitalized patients with Clostridium difficile infection: a multicenter cohort study. Clin Infect Dis. 2013 Apr;56(8):1108-16. doi: 10.1093/cid/cis1209. Epub 2013 Jan 8.
citation: Ellis G, Gardner M, Tsiachristas A, Langhorne P, Burke O, Harwood RH, Conroy SP, Kircher T, Somme D, Saltvedt I, Wald H, O'Neill D, Robinson D, Shepperd S. Comprehensive geriatric assessment for older adults admitted to hospital. Cochrane Database Syst Rev. 2017 Sep 12;9(9):CD006211. doi: 10.1002/14651858.CD006211.pub3.
citation: Gregersen M, Pedersen AB, Damsgaard EM. Comprehensive geriatric assessment increases 30-day survival in the aged acute medical inpatients. Dan Med J. 2012 Jun;59(6):A4442.
citation: Leibovici-Weissman Y, Atamna A, Schlesinger A, Eliakim-Raz N, Bishara J, Yahav D. Risk factors for short- and long-term mortality in very old patients with Clostridium difficile infection: A retrospective study. Geriatr Gerontol Int. 2017 Oct;17(10):1378-1383. doi: 10.1111/ggi.12866. Epub 2016 Sep 20.
citation: Jorgensen SMD, Rubak TMM, Damsgaard EM, Dahlerup JF, Hvas CL. Faecal microbiota transplantation as a home therapy to frail older people. Age Ageing. 2020 Oct 23;49(6):1093-1096. doi: 10.1093/ageing/afaa073.
citation: Hvas CL, Dahl Jorgensen SM, Jorgensen SP, Storgaard M, Lemming L, Hansen MM, Erikstrup C, Dahlerup JF. Fecal Microbiota Transplantation Is Superior to Fidaxomicin for Treatment of Recurrent Clostridium difficile Infection. Gastroenterology. 2019 Apr;156(5):1324-1332.e3. doi: 10.1053/j.gastro.2018.12.019. Epub 2019 Jan 2.