Frail ElderlyCLODIFRAILNCT05447533
Clostridioides Difficile and Frailty
A study testing Comprehensive geriatric assessment (CGA), Continued geriatric care and Faecal microbiota transplantation (FMT) in people with Frail Elderly and Clostridioides Difficile, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frail Elderly, Clostridioides Difficile, Geriatric Assessment
- What is being tested?
- Comprehensive geriatric assessment (CGA), Continued geriatric care and Faecal microbiota transplantation (FMT)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- 1 siteDenmark
- Study dates
- 16 Sep 2022to 16 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Patients aged ≥ 70 years and living in the Central Denmark Region
- Positive PCR test Clostridioides difficile
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Geriatrics, Aarhus University Hospital
Aarhus, 8220
About this study
Official title: Frail Old Patients With Clostridioides Difficile Infection: Improvement of Quality in Treatment and Care
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.
Read the 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.
- Conditions
- Frail Elderly, Clostridioides Difficile, Geriatric Assessment, Faecal Microbiota Transplantation, Aged
- Being tested
- Comprehensive geriatric assessment (CGA), Continued geriatric care, Faecal microbiota transplantation (FMT), Standard care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 careOther
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 careOther
Standard care: Patients are not contacted by the geriatric team. They receive usual treatment at the treating physician's discretion.
| Study group | Role | What they receive |
|---|---|---|
| Geriatric tailored assessment and intervention | Other | 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. Receives: Other: Comprehensive geriatric assessment (CGA); Other: Continued geriatric care; Other: Faecal microbiota transplantation (FMT) |
| 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. Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 83-97 weekdays after date of positive PCR test for Clostridioides difficile.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start16 Sep 2022
- Primary completion16 Aug 2023
- Study completion16 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Frail ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Horsens Hospital, Randers Regional Hospital, Central Jutland Regional Hospital
- Responsible party
- Sponsor
- Investigators
- Else Marie Damsgaard, Professor, Principal investigator, Department of Geriatrics, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05447533
- Sponsor's protocol ID
- 1106
- Acronym
- CLODIFRAIL
- Status last verified
- May 2023
- First submitted
- 28 Jun 2022
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21084111Czepiel 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.
PubMed 33805755Cober 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.
PubMed 19392957Hensgens 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.
PubMed 23300235Ellis 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.
PubMed 28898390Gregersen 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.
PubMed 22677240Leibovici-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.
PubMed 27647625Jorgensen 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.
PubMed 32365381Hvas 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.
PubMed 30610862Rubak 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.
PubMed 39488230
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frail Old Patients With Clostridioides Difficile Infection: Improvement of Quality in Treatment and Care
- ClinicalTrials.gov ID
- NCT05447533
- Acronym / sponsor ID
- CLODIFRAIL / 1106
- Conditions
- Frail Elderly, Clostridioides Difficile, Geriatric Assessment, Faecal Microbiota Transplantation, Aged
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Horsens Hospital, Randers Regional Hospital, Central Jutland Regional Hospital
- Study start
- 16 Sep 2022 (actual)
- Primary completion
- 16 Aug 2023 (actual)
- Study completion
- 16 Aug 2023 (actual)
- First posted
- 7 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Geriatric tailored assessment and intervention | Other | Other: Comprehensive geriatric assessment (CGA), Other: Continued geriatric care, Other: 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 | Active comparator | Other: Standard careStandard 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. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Patients aged ≥ 70 years and living in the Central Denmark Region
- Positive PCR test Clostridioides difficile
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive geriatric assessment (CGA)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: 1. Severe index, recurrent or refractory CDI as defined by national clinical guidelines or 2. High risk patient according to CGA at first visit. High risk patient is defined frailty grade MPI-2 (moderate) or MPI-3 (severe). | Other | Geriatric tailored assessment and intervention |
| Continued geriatric careContinued 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. | Other | Geriatric tailored assessment and intervention |
| Faecal microbiota transplantation (FMT)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. | Other | Geriatric tailored assessment and intervention |
| Standard careStandard care: Patients are not contacted by the geriatric team. They receive usual treatment at the treating physician's discretion. | Other | Standard care |
Primary outcome
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.
4 secondary outcomes
Physical functional status
Time frame: 83-97 weekdays after date of positive PCR test for Clostridioides difficile.
Overall quality of life assessed by Depression List
Time frame: 83-97 weekdays after date of positive PCR test for Clostridioides difficile.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
- Background: PubMed 21084111Bauer 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.
- Background: PubMed 33805755Czepiel 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.
- Background: PubMed 19392957Cober 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.
- Background: PubMed 23300235Hensgens 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.
- Background: PubMed 28898390Ellis 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.
- Background: PubMed 22677240Gregersen 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.
- Background: PubMed 27647625Leibovici-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.
- Background: PubMed 32365381Jorgensen 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.
- Background: PubMed 30610862Hvas 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.
- Derived from this study: PubMed 39488230Rubak 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Else Marie Damsgaard, Professor principal investigator
Department of Geriatrics, Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive geriatric assessment (CGA), Continued geriatric care and Faecal microbiota transplantation (FMT) in people with Frail Elderly and Clostridioides Difficile, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05447533, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2023.