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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
| Horsens Hospital | OTHER |
| Randers Regional Hospital | OTHER |
| Central Jutland Regional Hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Geriatric tailored assessment and intervention | Other | The geriatric tailored intervention consists of the following components:
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|
| Standard care | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| 90-day mortality | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Physical functional status | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrent Clostridioides difficile infection | 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. | Within period of 90-day follow-up from date of positive PCR test for Clostridioides difficile. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Else Marie Damsgaard, Professor | Department of Geriatrics, Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Geriatrics, Aarhus University Hospital | Aarhus | 8220 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21084111 | Background | 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. | |
| 33805755 | Background | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 26, 2022 | Jun 27, 2022 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D015577 | Geriatric Assessment |
| D000069467 | Fecal Microbiota Transplantation |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D006304 | Health Status |
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| OTHER |
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).
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Functional capacity and Overall Quality of life will be performed on both groups by a trained blinded project assistant during planned visits to the patients. The project assistant will be blinded to randomization status in redcap database.
|
| 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. |
|
| 83-97 weekdays after date of positive PCR test for Clostridioides difficile. |
| Overall quality of life assessed by Depression List | 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. | 83-97 weekdays after date of positive PCR test for Clostridioides difficile. |
| Quality of life assessed by the 5-level EQ-5D Interviewer version | 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. | 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 | 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. | 83-97 weekdays after date of positive PCR test for Clostridioides difficile. |
| Time to Faecal microbiota transplantation | Time from date of positive PCR test for Clostridioides difficile to date of faecal microbiota transplantation. | Within period of 90-day follow-up. |
| Time to initiation of vancomycin/bactocin treatment | Time from positive PCR test for Clostridioides difficile to date of initiation of medical treatment with vancomycin/bactocin. | Within period of 90-day follow-up. |
| Readmission in patients diagnosed with Clostridioides difficile during hospitalisation | 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. | Within a period of 30 days after hospital discharge. |
| Days in hospital | Number of days in hospital from date of positive PCR test for CD and until 90 days. | Within period of 90-day follow-up after positive PCR test for CD. |
| 19392957 | Background | 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. |
| 23300235 | Background | 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. |
| 28898390 | Background | 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. |
| 22677240 | Background | 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. |
| 27647625 | Background | 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. |
| 32365381 | Background | 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. |
| 30610862 | Background | 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. |
| 39488230 | Derived | Rubak T, Baunwall SMD, Gregersen M, Paaske SE, Asferg M, Barat I, Secher-Johnsen J, Riis MG, Rosenbaek JB, Hansen TK, Orum M, Steves CJ, Veilbaek H, Hvas CL, Damsgaard EMS. Early geriatric assessment and management in older patients with Clostridioides difficile infection in Denmark (CLODIfrail): a randomised trial. Lancet Healthy Longev. 2024 Dec;5(12):100648. doi: 10.1016/j.lanhl.2024.100648. Epub 2024 Oct 30. |
| D003710 |
| Demography |
| D011154 | Population Characteristics |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D019984 | Quality Indicators, Health Care |
| D006298 | Health Services Administration |