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NCT05447533: CLODIFRAIL
Clostridioides Difficile and Frailty
NA trial testing Comprehensive geriatric assessment (CGA) in Frail Elderly in 217 participants. Completed in 16 August 2023.
16 August 2023
Quick facts
| Lead sponsor | University of Aarhus |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | supportive care |
| Enrollment | 217 |
| Start date | 16 September 2022 |
| Primary completion | 16 August 2023 |
| Estimated completion | 16 August 2023 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Comprehensive geriatric assessment (CGA)
- Continued geriatric care
- Faecal microbiota transplantation (FMT)
- Standard care — full drug profile →
Conditions studied
- Frail Elderly — all drugs for Frail Elderly →
- Clostridioides Difficile — all drugs for Clostridioides Difficile →
- Geriatric Assessment — all drugs for Geriatric Assessment →
- Faecal Microbiota Transplantation — all drugs for Faecal Microbiota Transplantation →
Sponsor
University of Aarhus
Who can join
70 and older, any sex, with Frail Elderly or Clostridioides Difficile. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Early geriatric assessment and management in older patients with Clostridioides difficile infection in Denmark (CLODIfrail): a randomised trial.
Rubak T, Baunwall SMD, Gregersen M, Paaske SE, et al · · 2024 · cited 4× · PMID 39488230 · DOI 10.1016/j.lanhl.2024.100648 -
Clostridioides difficile infection in frail older patients, quality in treatment and care: the CLODIFRAIL study protocol for a multicentre randomised controlled trial
Rubak T, Veilbæk H, Gregersen M, Asferg M, et al · · 2023 · DOI 10.21203/rs.3.rs-2687093/v1
Verify or expand the search:
- PubMed search for NCT05447533
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05447533 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Aarhus
- Last refreshed: 18 August 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05447533.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing