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NCT04259931
PROSPECTIVE STUDY OF PREDISPOSING FACTORS OF REFRACTARY Clostridium Difficile INFECTION. INFLUENCE OF THE GUT MICROBIOMA
trial testing microbiome analysis in Clostridium Difficile Infection in 50 participants. Status unknown.
1 December 2020
Quick facts
| Lead sponsor | Hospital Universitario de Cabuenes |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 50 |
| Start date | 1 March 2020 |
| Primary completion | 1 December 2020 |
| Estimated completion | 1 June 2021 |
Drugs / interventions tested
- microbiome analysis
Conditions studied
- Clostridium Difficile Infection — all drugs for Clostridium Difficile Infection →
Sponsor
Hospital Universitario de Cabuenes
Who can join
18 and older, any sex, with Clostridium Difficile Infection. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A higher frequency of recurrences in the University Hospital of Cabueñes (HUCAB) than in other hospitals in our area, including Central University Hospital of Asturias (HUCA) has been found. This increase does not seem to be related to underlying diseases, age, sex or predisposing factors classically described in this type of infection. This high rate of recurrence, together with the absence of response to all conventionally used antibiotic treatments, has important repercussions in the morbidity and mortality of patients, in the ecology of the hospital due to the risk of transmission of a strain of major severity and in the high costs associated with an increase in the hospitalization days of these patients, as well as in an eventual transfer of these to other structures specialized in fecal transplantation. Two hypotheses are proposed to explain the higher frequency reported: Hypothesis 1. There are alterations of the microbiome in patients with severe recurrences that favor the appearance of these. Hypothesis 2. The circulating strain in the hospital has intrinsic characteristics that make it more virulent, such as the presence of virulence or multiresistance factors. For this reason we design a descriptive, prospective multicentric study that will include all patients older than 18 years diagnosed with C difficile infection at the Central University Hospital of Asturias and the University Hospital of Cabueñes during the year 2020-2021
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Related trials
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Other recruiting trials for Clostridium Difficile Infection
Currently open trials in the same condition.
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- NCT06703918 — Study on Clostridium Difficile Infection in Infants · recruiting
- NCT04305769 — Alanyl-glutamine Supplementation for C. Difficile Treatment (ACT) · Phase 2 · recruiting
- NCT04014413 — Safety and Efficacy of Fecal Microbiota Transplantation · NA · recruiting
- NCT03562741 — Outcomes and Data Collection for Fecal Microbiota Transplantation for the Treatment of Recurrent Clostridium Difficile · NA · recruiting
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 NCT04259931 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospital Universitario de Cabuenes
- Last refreshed: 7 February 2020
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