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Clostridium Difficile Infection clinical trials

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NCT ID: NCT03268213 Completed - Ulcerative Colitis Clinical Trials

Fecal Microbial Transplantation for C. Difficile and/or Ulcerative Colitis or Indeterminate Colitis

FMT
Start date: November 2013
Phase: Early Phase 1
Study type: Interventional

Fecal Microbiota Transplantation will be offered to eligible C. difficile patients (does not require Investigational New Drug designation) and to eligible ulcerative colitis or indeterminate colitis patients as Investigational New Drug treatment

NCT ID: NCT03250104 Completed - Clinical trials for Clostridium Difficile Infection

Antibiotic Stewardship and Infection Control in Patients at High Risk of Developing Infection by Clostridium Difficile, Vancomycin-Resistant Enterococci or Multi-Resistant Gram-Negatives

ABSOLUTE
Start date: November 2016
Phase:
Study type: Observational

Throughout project, the investigators design, evaluate and disseminate infection control and antibiotic stewardship (ABS) measures aimed at reducing the incidence of Clostridium difficile infection (CDI). The measures will focus on known departments with high incidence of CDI, i.e. a) hematology/oncology, b) other departments/wards demonstrating above-average infection rates, which were identified throughout previous studies. The infection control package will include staff training, hand hygiene programs and disinfection measures. Throughout the ABS package, investigators will develop and implement ABS measures specifically designed for patients at the highest risk of developing hospital-acquired infections, i.e. those treated on hematological/oncological wards. Potentially useful ABS actions even in critically ill patients are early reduction of exposure based on microbiological results, timely cessation of anti-infective treatment, thoughtful implementation of screening measures and biomarkers, defined approaches to patients known to be allergic to penicillins, and vigorous enforcement of clinical and microbiological diagnosis of infection focus. The IC and ABS measures aim at educating and assisting clinical personnel in realizing treatments according to official guidelines. There will not be a direct contact between study personnel and patient. There will be no direct recruitment of patients.

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: NCT03183128 Completed - Clinical trials for Clostridium Difficile Infection

ECOSPOR III - SER-109 Versus Placebo in the Treatment of Adults With Recurrent Clostridium Difficile Infection

ECOSPORIII
Start date: July 10, 2017
Phase: Phase 3
Study type: Interventional

Subjects will receive an oral dose of SER-109 in 4 capsules once daily for 3 consecutive days in Treatment Group I or matching placebo once daily for 3 consecutive days in Treatment Group II. The purpose of this study is to demonstrate the superiority of SER-109 vs placebo to reduce recurrence of CDI as determined by a toxin assay in adults up to 8 weeks after initiation of treatment.

NCT ID: NCT03182907 Completed - Clinical trials for Clostridium Difficile Infection

Bezlotoxumab (MK-6072) Versus Placebo in Children With Clostridium Difficile Infection (CDI) (MK-6072-001)

MODIFY III
Start date: March 27, 2018
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are to evaluate the pharmacokinetics (PK), safety, and tolerability of bezlotoxumab (MK-6072) in children aged 1 to <18 years of age with a confirmed diagnosis of Clostridium difficile infection (CDI) who are receiving antibacterial drug treatment. The primary hypothesis is that the area under the concentration-time curve from 0 to infinity (AUC0-inf) of bezlotoxumab after treatment of pediatric participants with bezlotoxumab is similar when compared to the AUC0-inf of bezlotoxumab after treatment of adults with bezlotoxumab.

NCT ID: NCT03141775 Recruiting - Clinical trials for Clostridium Difficile Infection

Incidence and Economic Burden of Clostridium Difficile Infections (CDI) in the German Health Care System (IBIS)

IBIS
Start date: August 1, 2017
Phase: N/A
Study type: Observational

IBIS is a prospective, observational study, which aims to assess the cost of CDI per day, hospitalization and year including description of incremental costs in hospitalized patients, and recurrent episodes, in German hospitals. Exposure to CDI drugs will not be influenced and remains at the discretion of the treating physician. In addition to treatment, Health-related quality of life (HRQL) will be analyzed using standardized questionnaires.

NCT ID: NCT03107169 Completed - Clinical trials for Clostridium Difficile Infection

Treatment of Initial Clostridium Difficile Infection

Start date: February 1, 2015
Phase: N/A
Study type: Interventional

Investigators designed an open, two-arm study to compare oral vancomycin with a fecal microbiota transplant (FMT) from a fecal donor-unrelated donor mix (FURM) as treatments for the first Clostridium difficile infection (CDI) episode among hospitalized patients.

NCT ID: NCT03106844 Completed - Clinical trials for Inflammatory Bowel Diseases

The ICON Study: Outcomes After FMT for Patients With IBD and CDI

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

In this study the investigators will evaluate patients with IBD and and at least 2 confirmed c.difficile infections who will be undergoing FMT. The investigators will assess patients before FMT and then follow patients prospectively post FMT at week 1, 8 and 12 to assess for recurrence of c.difficile infection and IBD outcomes.

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: NCT03090191 Completed - Clinical trials for Clostridium Difficile Infection

Clostridium Difficile Vaccine Efficacy Trial

Clover
Start date: March 29, 2017
Phase: Phase 3
Study type: Interventional

The Clover trial is evaluating an investigational vaccine that may help to prevent Clostridium difficile infection. Participants in the study are adults 50 years of age and older, who are at risk of developing Clostridium difficile infection. The study will assess whether the vaccine prevents the disease, and whether it is safe and well tolerated. Each subject will receive 3 doses of Clostridium difficile vaccine or placebo and be followed for up to 3 years after vaccination for potential Clostridium difficile infection.