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Clostridium Difficile Infection clinical trials

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NCT ID: NCT04000555 Terminated - Clinical trials for Clostridium Difficile Infection

Oral Vancomycin for Secondary Prophylaxis of Clostridium Difficile Infection (CDI)

Start date: September 1, 2019
Phase: Phase 4
Study type: Interventional

The purpose of this study is to gain further knowledge regarding the effectiveness of vancomycin prophylaxis in preventing Clostridium difficile infections in order to guide physicians' practices.

NCT ID: NCT03795233 Terminated - Clinical trials for Clostridium Difficile Infection

Fecal Microbiota Transplant for Primary CDI

Start date: August 23, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

Clostridium difficile infection (CDI) is one of the most urgent health threats in the U.S. associated with antibiotic use. After an initial episode, disease recurrence is high and relapses can occur in 20-30% of people treated with oral vancomycin. An antibiotic course can affect the gut microbiome for years, and patients with CDI have additional dysbiosis of their gut flora. Oral vancomycin perturbs the gut microbiome further. Restoration of the microbiome with Fecal Microbiota Transplant (FMT) has been proven a highly efficacious and cost-effective treatment for recurrent CDI. FMT has had very limited study for a primary episode of CDI to date because an endoscopic procedure was the recommended route of delivery. However, FMT is now available via frozen oral capsules and has been shown to be non-inferior to FMT via colonoscopy in randomized controlled trials. The investigators hypothesize that outcomes after a first episode of CDI can be improved if the microbiome is restored with oral FMT. It is further hypothesized that this will compensate for any additional microbiome perturbation caused by administration of oral vancomycin and decrease the likelihood of recurrence. Because the hypothesis is based on restoration of the microbiome, the investigators propose this proof-of-concept pilot study to examine whether FMT administered after oral vancomycin therapy for primary CDI restores microbiome diversity compared to patients who do not receive FMT. Because of the potential health benefits, this approach deserves further study. The results from this pilot study on the microbiome diversity as well as the surveys to be conducted about GI symptomatology (e.g., diarrhea, abdominal pain, bloating), CDI recurrence and healthcare utilization, would provide preliminary data to support a randomized controlled, multicenter clinical trial.

NCT ID: NCT03200093 Terminated - Clinical trials for Clostridium Difficile Infection

Oral Vancomycin for Preventing Clostridium Difficile Recurrence

Start date: June 8, 2017
Phase: Phase 4
Study type: Interventional

This study evaluates the role of oral vancomycin in the prevention of recurrent Clostridium difficile for hospitalized patients receiving systemic antibiotic therapy. Half of participants will receive oral vancomycin daily, while the other half will receive a placebo.

NCT ID: NCT03105479 Terminated - Clinical trials for Clostridium Difficile Infection

Comparison of Cadazolid Versus Vancomycin in Children With Clostridium Difficile-associated Diarrhea (CDAD)

Start date: April 14, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

Cadazolid has demonstrated activity against a bacteria named Clostridium difficile in animal studies. The results of a first study conducted in adult patients have suggested efficacy of the new antibiotic, cadazolid, in the treatment of diarrhea caused by this bacteria. This is the first study of cadazolid in children. The overall purpose of this study is to provide reassurance on the safety and efficacy of cadazolid in children suffering from infection due to Clostridium difficile.

NCT ID: NCT03065374 Terminated - Clinical trials for Clostridium Difficile Infection

Treatment for Clostridium-difficile Infection With IMM529

Start date: September 1, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This study will evaluate the safety and tolerability of IMM-529 together with standard of care (SOC) in patients with Clostridium-difficile Infection.

NCT ID: NCT03005379 Terminated - Clinical trials for Clostridium Difficile Infection

Microbiota or Placebo After Antimicrobial Therapy for Recurrent C. Difficile at Home (MATCH)

MATCH
Start date: November 15, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to determine whether Fecal Microbiota Therapy (FMT) is effective vs. placebo in the prevention of C. difficile infection recurrence.

NCT ID: NCT02991417 Terminated - Clinical trials for Clostridium Difficile Infection

Oral Vaccination Against Clostridium Difficile Infection

CDVAX
Start date: January 2017
Phase: Phase 1
Study type: Interventional

This clinical study is conducted to assess the safety and immunogenicity of a Clostridium difficile vaccine (CDVAX) in healthy adult volunteers.

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: NCT02395848 Terminated - Clinical trials for Clostridium Difficile Infection

Efficacy of 30-day Duration of Fidaxomicin for Recurrent C. Difficile Infection

Start date: July 2015
Phase: Phase 3
Study type: Interventional

This is a medical research study designed to look at the safety and efficacy of 30-day course of fidaxomicin for treatment of recurrent CDI (Clostridium difficile Infection). CDI is an infection that results when the normal flora (resident bacteria) of the colon is substantially altered by antibiotic treatment. The decrease in this normal flora allows for the growth of the C. difficile bacteria. Fidaxomicin is an antibiotic which is approved by Health Canada for treatment of CDI. Only patients with a primary case of CDI or 1st episode of recurrent CDI have been studied using a 10-day course of fidaxomicin.

NCT ID: NCT02301000 Terminated - Clinical trials for Clostridium Difficile Infection

IMT for Primary Clostridium Difficile Infection

Start date: February 22, 2015
Phase: Phase 2/Phase 3
Study type: Interventional

This is a randomized controlled trial to compare the effect of a 10-day course of per oral metronidazole versus a one-time rectal instillation of an anaerobically cultivated human intestinal microbiota for the treatment of a first occurrence of Clostridium difficile infection (CDI). Recurrent CDI is common after standard antibiotic treatment. We hypothesize that the instillation of a healthy intestinal microbiota will be more effective in inducing a durable cure than metronidazole for primary CDI.