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Clostridium Infections clinical trials

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NCT ID: NCT04567134 Not yet recruiting - Clinical trials for Clostridium Difficile Infection

Clostridioides Difficile Infection - a Prospective Nationwide Epidemiologic Study in Korea

Start date: October 1, 2020
Phase:
Study type: Observational

Our objective of this study is to derive a real incidence of CDI in tertiary hospitals located through Korean peninsula. In order to get a close value to the truth, the study is planned to co-perform with a national study which was proposed in evaluation process to include more hospitals. Along with the incidence of CDI, clinical characteristics and outcome of CDI will be examined and microbiologic characteristics of C. difficile isolates from CDI patients are studied.

NCT ID: NCT04415918 Not yet recruiting - Clinical trials for Clostridium Difficile Infection Recurrence

Bezlotoxumab Efficacy and Tolerability in Cancer Patient

Start date: July 1, 2020
Phase: Phase 4
Study type: Interventional

Investigation of efficacy and tolerability of bezlotoxumab in patients with cancer diagnosis in terms of preventing CDI recurrence.

NCT ID: NCT04317963 Completed - Clinical trials for Clostridium Difficile Infection

Real-world Evaluation of Bezlotoxumab for the Management of Clostridioides Difficile Infection

Start date: February 12, 2020
Phase:
Study type: Observational

This is a retrospective case:control study examining the use of adjunctive bezlotoxumab to standard C. difficile infection (CDI) treatment compared to standard CDI treatment alone in patients with CDI seen in an academic medical center's specialty outpatient clinic.

NCT ID: NCT04305769 Recruiting - Clinical trials for Clostridium Difficile Infection

Alanyl-glutamine Supplementation for C. Difficile Treatment (ACT)

ACT
Start date: June 1, 2021
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, placebo-controlled trial to determine the optimal dose and safety of oral alanyl-glutamine between 4, 24, and 44 g doses administered for 10 days with standard therapy among first time incident cases of uncomplicated C. difficile infection (CDI) in hospitalized, or outpatient, persons aged 18 or older. Our hypothesis is that alanyl-glutamine supplementation will decrease recurrence and mortality from CDI and these outcomes will be associated with improvement of inflammatory markers and restoration of intestinal microbiota function.

NCT ID: NCT04259931 Not yet recruiting - Clinical trials for Clostridium Difficile Infection

PROSPECTIVE STUDY OF PREDISPOSING FACTORS OF REFRACTARY Clostridium Difficile INFECTION. INFLUENCE OF THE GUT MICROBIOMA

Start date: March 1, 2020
Phase:
Study type: Observational

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

NCT ID: NCT04247542 Completed - Clinical trials for Clostridium Difficile Infection

ACX-362E [Ibezapolstat] for Oral Treatment of Clostridioides Difficile Infection

Start date: March 6, 2020
Phase: Phase 2
Study type: Interventional

Segments 2A and 2B of this trial evaluate the safety, efficacy, pharmacokinetics, fecal concentrations, and fecal microbiome effects of ACX-362E [ibezapolstat] in patients with C. difficile infection (CDI).

NCT ID: NCT04246151 Recruiting - Clinical trials for Clostridium Difficile Diarrhea

Oral Vancomycin Versus Probiotics Versus Placebo for Prevention of Clostridium Difficile Infection in Colonized Patients

Decency-RCT
Start date: September 1, 2022
Phase: Early Phase 1
Study type: Interventional

The goal of this pilot study is to assess the feasibility of randomizing hospitalized patients that are colonized with C. difficile and started on systemic antibiotics to either a probiotic, oral vancomycin, or placebo in a parallel-group 1:1:1 design. The ultimate goal is to conduct an appropriately-powered RCT to determine the optimal method for reducing C difficile infection in colonized patients.

NCT ID: NCT04187430 Recruiting - Clinical trials for Clostridium Difficile Infection

Validation of a Prediction Score for Recurrent C. Difficile Infection: Implementation for Treatment Algorithm Strategies

Clostri_Score
Start date: December 1, 2019
Phase:
Study type: Observational

The objective of the present study is to derive a high-risk R-ICD prediction rule and a prospective implementation of this prediction rule.

NCT ID: NCT04179201 Recruiting - Clinical trials for Inflammatory Bowel Diseases

Study on Clostridium Difficile Infection in Chinese Patients With Inflammatory Bowel Disease

Start date: September 13, 2017
Phase:
Study type: Observational

In recent years, the incidence of Inflammatory Bowel Disease (IBD) has been increasing in China, which poses great challenges and burdens to the medical community due to its unknown etiology, recurrence and incurability. Co-infection is one of the important causes in IBD development. IBD accompanied with Clostridium Difficile Infection (CDI) can significantly decrease the treatment efficiency, leading to increased surgical rate, increased mortality, prolonged hospital stay, and increased hospital costs. Recently, several Chinese clinical guidelines about IBD or CDI have been published, but these guidelines are mainly based on the foreign studies. Compared with the developed countries, the lack of multi-center, large-scale and multi-test clinical trials and cohort studies caused limited understanding for IBD-CDI in China. Therefore, it is of great importance to carry out the multi-center clinical trials and analysis on IBD-CDI to improve the diagnostic and therapeutic efficiency in IBD-CDI patients Objective: 1. To evaluate the prevalence rate of IBD-CDI in Chinese adults in China based on the multi-center clinical trials.. 2. To analyze the related risk factors of IBD-CDI in China based on the multi-center clinical trials. 3. To analyze the intestinal flora of IBD-CDI patients via high-throughput sequencing.

NCT ID: NCT04138706 Recruiting - Clinical trials for Clostridium Difficile Infection

Initial Vancomycin Taper for the Prevention of Recurrent Clostridium Difficile Infection

TAPER-V
Start date: November 19, 2020
Phase: Phase 3
Study type: Interventional

The first line therapy for an initial episode of CDI (Clostridium difficile infection) is 10-14 days of oral vancomycin which is now recommended over metronidazole in the 2018 guidelines from the Association of Medical Microbiologists and Infectious Diseases of Canada (AMMI). Although response rates for the treatment of a first episode of CDI now approach 90%, approximately 25% of patients who have a complete response will develop recurrence (rCDI) within 8 weeks. Doctors' ability to predict recurrence is evolving, but remains very limited. The investigators hypothesize that by extending initial vancomycin therapy with a 2-week tapering regimen this will reduce the risk of rCDI. Starting at the end of the initial 14 days of therapy, participants will be randomized to receive an additional 14-days of placebo or vancomycin taper (125 mg orally twice daily x 7 days followed by 125 mg orally once daily x 7 days). This taper was chosen as it represents two steps of a commonly used 4-week vancomycin taper. The investigators' proposal to evaluate the extension of initial treatment from 14 to 28 days with a tapering dose of vancomycin represents a practical clinical trial that capitalizes on oral vancomycin's safety profile, worldwide availability, and relatively low cost.