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Clostridium Difficile Infection clinical trials

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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: 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: 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.

NCT ID: NCT04100603 Recruiting - Clinical trials for Clostridium Difficile Infection

A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Clostridoides Difficile Infection

Start date: March 2, 2020
Phase:
Study type: Observational

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

NCT ID: NCT04090346 Completed - Clinical trials for Clostridium Difficile Infection

Fecal Microbiota Transplant

Start date: June 5, 2018
Phase: Phase 4
Study type: Interventional

The study will provide data to show the effectiveness of Fecal Microbiota Transplant in patients with recurrent Clostridium difficile infection. Fecal Microbiota Transplant (FMT) is a procedure in which healthy colon contents of a carefully screened donor is inserted into the colon of a compromised patient. FMT is a procedure to replace beneficial bacteria that has been killed or suppressed, most commonly by use of antibiotics. Currently it is utilized as an experimental treatment for Clostridium difficile infection (CDI). This procedure is predicted to reduce the cost both financially and physically for the CDI patient and facility.

NCT ID: NCT04075422 Completed - Clinical trials for Clostridium Difficile Infection

Bezlotoxumab - in "Real Life" - During the First Episode of Clostridium Difficile Infection in Patients With High Risk of Recurrence.

BEFORE
Start date: October 1, 2019
Phase:
Study type: Observational

The main hypothesis of the study is that Bezlotoxumab is well tolerated and effective in reducing the recurrence of ICD (Clostridium Difficile infection) in patients with a high risk of recurrence in the first episode of ICD. As a consequence, the number of readmissions and hospital stays, will be reduced in patients treated with Bezlotoxumab.

NCT ID: NCT04014608 Completed - Clinical trials for Clostridium Difficile Infection

Protocol for Admission Toxigenic C. Difficile Surveillance

Start date: July 1, 2016
Phase:
Study type: Observational

Background: Clostridioides (formerly Clostridium) difficile Infection (CDI) is a persistent healthcare issue. In the US, CDI is the most common infectious cause of hospital-onset (HO) diarrhea. Objective: Assess the impact of admission testing for toxigenic C. difficile colonization on the incidence of clinical disease. Design: Pragmatic stepped-wedge Infection Control initiative. Setting: NorthShore University HealthSystem (NorthShore) is a four-hospital system near Chicago, Illinois. Patients: All patients admitted to the four hospitals during the initiative. Interventions: From September 2017 through August 2018 the investigators conducted a quality improvement program where admitted patients had a peri-rectal swab tested for toxigenic C. difficile. All colonized patients were placed in contact precautions. Measurements: The investigators tested admissions who: i) had been hospitalized within two months, ii) had a past C. difficile positive test, and/or iii) were in a long-term care facility within six months. The investigators measured compliance with all other measures to reduce the incidence of HO-CDI. Limitations: This was not a randomized controlled trial, and multiple prevention interventions were in place at the time of the admission surveillance initiative.