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Clostridium Infections clinical trials

View clinical trials related to Clostridium Infections.

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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).

NCT ID: NCT02563106 Completed - Clinical trials for Clostridium Difficile

A Study of SYN-004 for the Prevention of C.Diff in Patients With a LRTI

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

A Phase 2b Parallel-Group, Double-Blind, Placebo-Controlled, Multicenter Study of SYN-004 Compared to Placebo for the Prevention of Clostridium difficile Infection (CDI) in Hospitalized Patients receiving IV ceftriaxone with a Diagnosis of a Lower Respiratory Tract Infection (LRTI).

NCT ID: NCT02561195 Completed - Clinical trials for Clostridium Difficile Associated Disease

A Study To Investigate Two 3-dose Schedules Of A Clostridium Difficile Vaccine In Healthy Adults Aged 65 to 85 Years

Start date: July 16, 2015
Phase: Phase 2
Study type: Interventional

This study will investigate a Clostridium difficile vaccine in healthy adults aged 65-85 years. Each subject will initially receive 3 doses of vaccine on 1 of 2 vaccination schedules. The study will assess the safety and tolerability of the vaccine as well as the subjects' immune response to the vaccine. One year after the third dose subjects that did not receive placebo will be randomized to receive a fourth dose. Subjects will be followed for up to 4 years after their third vaccination.

NCT ID: NCT02461901 Completed - Clinical trials for Clostridium Difficile Infection

Does Fidaxomicin Therapy Reduce Spread of Clostridium Difficile?

Start date: January 2015
Phase:
Study type: Observational

This study evaluates whether patients with Clostridium difficile infection (CDI) who are treated with fidaxomicin have less contamination of their skin and surrounding environment with spores of C. difficile than patients treated with other drugs (metronidazole or vancomycin)

NCT ID: NCT02423967 Completed - Clinical trials for Clostridium Difficile

Fresh Versus Frozen Stool for Fecal Transplant in Children

Start date: April 2015
Phase: Phase 1
Study type: Interventional

The primary goal of this study will be to assess whether stool collected and frozen from anonymous screened unrelated donors can be as effective as stool freshly collected from recipient's parents when used in Fecal Microbial Transplant for the eradication of recurrent Clostridium difficile infections in children. In the current protocols, which are more than 90% effective, each child who is receiving a fecal transplant has to provide their own donor stool, usually from a parent or close relative. This requires considerable screening costs for each case and is logistically complicated as the donor must be present and must stool just prior to the transplant. The investigators hope to show that a small number of healthy donors can provide stool samples which can be frozen and banked and then thawed for use in numerous patients. The primary goal is to show that Clostridium difficile will be eradicated as effectively (Greater than 90% success) when using the stool from the frozen donors. The study will also evaluate the inflammatory response and intestinal microbiome in young children aged 1-3 years with Clostridium difficile infections to better predict which ones will respond to fecal transplantation and which ones have incidental infections. For this question the investigators will gather stool samples to check for lactoferrin, calprotectin, and alpha1antitrypsin, and 16s ribosomal RNA analysis in children before and after the fecal transplants. The goal is to see if there is an intestinal microbiome that predisposes some children to getting sick from Clostridium difficile versus just having it incidentally.

NCT ID: NCT02326636 Completed - Clinical trials for Clostridium Difficile Infection

Fecal Microbiota Transplant for Recurrent Clostridium Difficile Infection

FMT
Start date: April 2014
Phase:
Study type: Observational

The purpose of this research is to investigate the efficacy of transplanting screened donor fecal material in treating patients with recurrent Clostridium difficile infection. Participants with refractory Clostridium difficile infection will be given healthy donor stool administered by colonoscopy or enema and their response will be evaluated by symptom questionnaire and stool testing for Clostridium difficile at 4 weeks after the treatment.

NCT ID: NCT02299570 Completed - Clinical trials for Enterocolitis Clostridium Difficile Recurrent

Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection

PUNCHCD2
Start date: December 2014
Phase: Phase 2
Study type: Interventional

This is the first prospective, multi-center, double-blinded, randomized controlled study of a microbiota suspension derived from intestinal microbes. Patients who have had at least two recurrences of C. difficile infection (CDI) after a primary episode and have completed at least two rounds of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization may be eligible for the study. Patients whose CDI returns in less than 8 weeks after the last assigned study treatment may be eligible to receive up to 2 treatments with RBX2660 in the open-label portion of the study.

NCT ID: NCT02218372 Completed - Clinical trials for Clostridium Difficile-associated Diarrhea (CDAD)

A Study to Investigate the Safety and Efficacy of Fidaxomicin (Oral Suspension or Tablets) and Vancomycin (Oral Liquid or Capsules) in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD)

SUNSHINE
Start date: January 9, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study was to investigate the clinical response to fidaxomicin oral suspension or tablets and vancomycin oral liquid or capsules in pediatric participants with Clostridium difficile-associated diarrhea (CDAD). It also investigated the recurrence/sustained clinical response to and safety of fidaxomicin and vancomycin, as well as acceptance of the fidaxomicin oral suspension formulation.

NCT ID: NCT01925417 Completed - Clinical trials for Recurrent Clostridium Difficile Infection

Microbiota Restoration Therapy for Recurrent Clostridium Difficile-associated Diarrhea

PUNCH CD
Start date: August 2013
Phase: Phase 2
Study type: Interventional

This study will assess the safety of a new biologic drug, RBX2660 (microbiota suspension) as a treatment for recurrent Clostridium difficile-associated diarrhea (CDAD), which is the primary symptom of recurrent Clostridium difficile infection. All eligible subjects will receive RBX2660.