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Clostridium Infections clinical trials

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NCT ID: NCT02865616 Completed - Clinical trials for Clostridium Difficile Infection

MET-2 Clinical Study for Recurrent Clostridium Difficile Infection (CDI)

Start date: October 27, 2017
Phase: Phase 1
Study type: Interventional

MET-2 clinical study is an Open label, single center, multiple dose pilot study of 19 patients. The study is designed to measure the resolution of diarrhea as well as the feasibility of administration and safety of MET-2 for the treatment of recurrent CDI in patients who have experienced at least two prior episodes of CDI and have developed recurrence after having completed standard-of care oral antibiotic therapy to treat CDI.

NCT ID: NCT02830542 Completed - Clinical trials for Clostridium Difficile Infection

SER-262 Versus Placebo in Adults With Primary Clostridium Difficile Infection to Prevent Recurrence

Start date: August 2016
Phase: Phase 1
Study type: Interventional

The study will involve administering a single dose of investigational drug or placebo in ascending dose cohorts. This study is designed to evaluate the safety and tolerability of investigational drug as well as the efficacy of investigational drug versus placebo in adults with primary (first episode) Clostridium difficile infection (CDI).

NCT ID: NCT02801656 Withdrawn - Clinical trials for Clostridium Difficile

Fecal Microbiota Transplantation for Primary Clostridium Difficile Diarrhea

Start date: December 1, 2020
Phase: Phase 3
Study type: Interventional

Clostridium difficile associated diarrhea (CDAD) is a significant cause of morbidity and mortality, caused by loss of healthy gut flora. Conventional treatment uses antibiotics to kill Clostridium difficile. A novel treatment uses replacement of gut flora by fecal microbiota transplant (FMT). Randomized trials have established safety and efficacy of FMT in recurrent CDAD, but no trial has used FMT for primary CDAD. This study will randomize patients to oral encapsulated FMT or oral Vancomycin.

NCT ID: NCT02743234 Completed - Clinical trials for Clostridium Difficile Infection

Fecal Microbiota Transplantation for Relapsing Clostridium Difficile Infection

FACIT
Start date: April 2016
Phase: Phase 3
Study type: Interventional

Randomized open label clinical trial to compare the clinical and microbiological efficacy of fecal microbiota transplantation, fidaxomicin, and vancomycin for relapsing Clostridium difficile infection

NCT ID: NCT02730325 Terminated - Clinical trials for Clostridium Difficile

To Evaluate the Impact of SBI on C. Difficile in Hospitalized UC Patients

Start date: December 2015
Phase: N/A
Study type: Interventional

The effects of serum-derived bovine immunoglobulin/protein isolate (SBI) will be evaluated and compared to matching placebo in two distinct patient populations: I. Hospitalized ulcerative colitis (UC) patients who tested positive for Clostridium difficile (C. difficile) at time of admission and are receiving vancomycin. II. Hospitalized UC patients who tested negative for C. difficile at time of admission.

NCT ID: NCT02707198 Terminated - Diarrhea Clinical Trials

Prevention of Clostridium Difficile-associated Diarrhea by Daily Intake of Kefir

Start date: November 2015
Phase: Phase 2
Study type: Interventional

This study is being conducted to investigate the potential benefits of probiotic intake for preventing antibiotic associated diarrhea and Clostridium difficile infection in patients undergoing a systemic antibiotic treatment. The primary research question is: can daily intake of kefir, a yogurt-like food containing probiotics, reduce the incidence of diarrhea and Clostridium difficile infection in patients during antibiotic treatment?

NCT ID: NCT02692651 Completed - Clinical trials for Clostridium Difficile Infection (CDI)

A Comparison of Fidaxomicin and Vancomycin in Patients With CDI Receiving Antibiotics for Concurrent Infections

Start date: May 1, 2017
Phase: Phase 4
Study type: Interventional

Administration of concomitant antibiotics (CA) is a known risk factor for treatment failure in the treatment of CDI, as well as for recurrence of CDI. Recent data suggested that among patients receiving CA, fidaxomicin is superior to vancomycin. While these data are encouraging, many clinicians remain unclear on how to apply these data to patient care. Additionally, patients were excluded from the trials presented to the FDA if it was expected that they would require ≥ 7 days of CA. Therefore, the clinical question still remains of how to apply these data to the real world patient who requires a long course of CA and develops CDI while on therapy. We therefore propose an open label, comparative and prospective study of fidaxomicin 200 mg twice daily vs oral vancomycin 125 mg four times daily for the treatment of CDI among patients who are receiving a long course of CA. We hypothesize that fidaxomicin will be superior to vancomycin with respect to clinical cure for patients with CDI.

NCT ID: NCT02681068 Recruiting - Clinical trials for Clostridium Infections

MicroTrans - A Multicenter Registry of Fecal Microbiota Transplantation

MicroTrans
Start date: January 2015
Phase: N/A
Study type: Observational

The registry collects cases of patients received fecal microbiota transplantation (FMT) due to Clostridium difficile associated diarrhea (CDAD). The main objective of this study is to analyze the safety and effectiveness of FMT. Furthermore, data analysis will be used to implement a standardization of FMT in German hospitals and improve patient outcome. Therefore, a detailed description of completions of FMT are documented on our web-based survey platform www.ClinicalSurveys.net.

NCT ID: NCT02592343 Completed - Clinical trials for Clostridium Difficile Infection

A Prospective Trial of Lyophilized Fecal Microbiota Transplantation for Recurrent Clostridium Difficile Infection

Start date: January 2016
Phase: Phase 2
Study type: Interventional

The primary goal is to study patients with recurrent Clostridium difficile Infection (CDI) treated with lyophilized Fecal Microbiota Transplantation (FMT) in an open-labelled controlled trial. The treatment failure rate will be evaluated as defined by the persistence of diarrhea and a positive C. difficile toxin assay. The safety, clinical response, and relapse rate in patients will be assessed.

NCT ID: NCT02589847 Completed - Clinical trials for Clostridium Difficile Infection

Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection

Start date: October 2015
Phase: Phase 2
Study type: Interventional

This study will evaluate efficacy and safety information about RBX2660 for the treatment of recurrent Clostridium difficile infection (CDI), and will compare the efficacy of one treatment with RBX2660 versus antibiotic-treated historical controls. Enrolled subjects will receive one treatment consisting of two doses of RBX2660 (microbiota suspension).