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Clostridium Difficile Infection clinical trials

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NCT ID: NCT01946750 Completed - Clinical trials for Clostridium Difficile Infection

Predictive Value of the Immune Response of the Host in Clostridium Difficile Infections

SERODIFF
Start date: December 2012
Phase: N/A
Study type: Interventional

Hypothesis: the antibody directed against certain antigens of Clostridium difficile would be predict the Clostridium difficile infection. This study evaluates the weight of immunity by studying patients with Clostridium difficile infection versus controls (each patient is associated with two controls : diarrheal control without Clostridium difficile, and non-diarrheal control with or without Clostridium difficile). Recurrence and the kinetics of immune response following infection Clostridium difficile are studied by following the patients during three months. There are also building biological samples collections clinically documented: sera, stool and strains.

NCT ID: NCT01930032 Completed - Clinical trials for Clostridium Difficile Infection

Pathogenic Mechanisms in C Diff Infection and Colitis

Start date: August 2013
Phase: N/A
Study type: Observational

The purpose of this study is to learn more about infection by Clostridium difficile (also known as C. difficile). C. difficile is a common bacterium (a germ that may cause disease) that can live in the human gut. Some people have it without having any symptoms. In other people it can cause illness ranging from mild diarrhea to severe colitis (infection of the colon). C. difficile makes toxins that damage the cells that line the colon. The study doctors want to find out how these toxins cause damage to the cells in the colon.

NCT ID: NCT01914731 Completed - Clinical trials for Clostridium Difficile Infection

Fecal Microbiota Transplant for Relapsing Clostridium Difficile Infection in Adults and Children Using a Frozen Encapsulated Inoculum

Start date: August 2013
Phase: Phase 1
Study type: Interventional

Fecal microbiota transplantation (FMT) is the reconstitution of normal flora by a "stool transplant" from a healthy individual to a C. difficile-infected recipient, and has long been a successful approach to recurrent/refractory C. difficile. The purpose of this project is to generate a frozen FMT inoculum from well-screened healthy volunteer donors which can be used repeatedly, particularly in those who do not have a healthy intimate partner or other related donor. Delivery of FMT has been performed colonoscopically, by fecal retention enema, or by the nasogastric route. This study will evaluate the safety and secondarily the efficacy of an inoculum administered by frozen orally-administered capsules. Subjects with recurrent/relapsing C. difficile infection will receive FMT via oral capsules The primary endpoint is assessment of safety as measured by clinical events (GI, procedural, systemic). Efficacy will be defined as a resolution of diarrhea off antibiotics for C. difficile, in the absence of a need for OTHER systemic antibiotics, i.e. resumption of a normal bowel status for the individual. Secondary efficacy endpoints include weight, subjective well-being and relative clinical improvement per standardized questionnaire, and subject qualitative assessment of, and satisfaction with, the transplant procedures. Subjects will be monitored for clinical safety by history and standard exams and the follow-up questionnaire as well as followed closely by phone and in person.

NCT ID: NCT01896830 Completed - Clinical trials for Clostridium Difficile Infection

Study of a Candidate Clostridium Difficile Toxoid Vaccine in Healthy Adult Subjects Aged 40 to 75 Years in Japan

Start date: July 2013
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of the study is to evaluate a candidate C. difficile Toxoid Vaccine in the Japanese population. Primary objectives: - To describe the safety profile of all subjects who receive at least 1 injection - To describe the immunogenicity to toxin A and toxin B in all subjects from serum samples obtained on Days 0, 14, 30, and 60.

NCT ID: NCT01822977 Completed - Healthy Clinical Trials

The Impact of Proton Pump Inhibitors on the Fecal Microbiome

Start date: March 2013
Phase: Phase 1
Study type: Interventional

The investigators hypothesis is that daily use of a proton pump inhibitor (PPI) is associated with significant alterations in the healthy fecal microbiome that are similar to those seen in persons with an initial episode of clostridium difficile infection (CDI).

NCT ID: NCT01704937 Completed - Clinical trials for Clostridium Difficile Infection

Fecal Microbiota Transplant (FMT) for Relapsing C. Difficile Infection in Adults and Children Using a Frozen Inoculum

Start date: November 2012
Phase: Phase 1
Study type: Interventional

Fecal microbiota transplantation (FMT) is the reconstitution of normal flora by a "stool transplant" from a healthy individual to a C. difficile-infected recipient, and has long been a successful approach to recurrent/refractory C. difficile. The purpose of this project is to generate a frozen FMT inoculum from well-screened healthy volunteer donors which can be used repeatedly, particularly in those who do not have a healthy intimate partner or other related donor. Delivery of FMT has been performed colonoscopically, by fecal retention enema, or by the nasogastric route. This study will evaluate the safety and secondarily the efficacy of a frozen inoculum administered by nasogastric tube vs administered by colonoscope. Subjects with recurrent/relapsing C. difficile infection (10 per group) will receive FMT via either: - colonoscopy - NGT The primary endpoint is assessment of safety as measured by clinical events (GI, procedural, systemic). Efficacy will be defined as a resolution of diarrhea off antibiotics for C. difficile, in the absence of a need for OTHER systemic antibiotics, i.e. resumption of a normal bowel status for the individual. Secondary efficacy endpoints include weight, subjective well-being and relative clinical improvement per standardized questionnaire, and subject qualitative assessment of, and satisfaction with, the transplant procedures. Subjects will be monitored for clinical safety by history and standard exams and the follow-up questionnaire as well as followed closely by phone and in person.

NCT ID: NCT01670149 Completed - Clinical trials for Clostridium Difficile Infection

Rifaximin for Preventing Relapse of Clostridium Associated Diarrhoea

RAPID
Start date: December 2012
Phase: Phase 4
Study type: Interventional

Clostridium difficile associated diarrhoea is an important cause of morbidity in patients treated with antibiotics, especially in hospital. Clinical relapse occurs after up to 30% of initially successful treatments for colitis. Preliminary reports suggest that Rifaximin, a poorly absorbed antibiotic used to treat travellers diarrhoea can prevent relapse. We plan to carry out a randomised placebo controlled trial to test the hypothesis that Rifaximin given in a reducing dose over 4 weeks after successful treatment will reduce the relapse rate.

NCT ID: NCT01598311 Completed - Clinical trials for Clostridium Difficile Infection

A Study of CB-183,315 in Participants With Clostridium Difficile Associated Diarrhea (MK-4261-006)

Start date: May 16, 2012
Phase: Phase 3
Study type: Interventional

A total of 608 participants with Clostridium Difficile Associated Diarrhea (CDAD) will participate in this study; participants will receive either oral vancomycin or CB-183,315 in a blinded fashion. Treatment will last for 10 days and participants will be followed up for at least 40 days and a maximum of 100 days. The purpose of this study is to evaluate how well CB-183,315 treats CDAD as compared to vancomycin.

NCT ID: NCT01597505 Completed - Clinical trials for Clostridium Difficile Infection

Study of CB-183,315 in Participants With Clostridium Difficile Associated Diarrhea (MK-4261-005)

Start date: May 16, 2012
Phase: Phase 3
Study type: Interventional

606 participants with Clostridium Difficile Associated Diarrhea (CDAD) participated in this study and received either oral vancomycin or CB-183,315 (surotomycin) in a blinded fashion. Treatment lasted for 10 days and participants were followed up for at least 40 days and a maximum of 100 days. The purpose of this study was to evaluate how well surotomycin treats CDAD as compared to vancomycin.

NCT ID: NCT01560832 Completed - Clinical trials for Clostridium Difficile Infection

Descriptive Epidemiology of Clostridium Difficile Infection in Hospitalized Adult Patients in the Asia Pacific Region

Start date: December 2011
Phase: N/A
Study type: Observational

Clostridium difficile is an important pathogen, causing disease that ranges from mild self-limited diarrhea to life-threatening pseudomembranous colitis. It is estimated that C. difficile is responsible for 10% to 25% of all cases of antibiotic-associated diarrhea and for almost all cases of pseudomembranous colitis. C. difficile disease is mediated by two large toxins, A and B. The toxins damage intestinal epithelial cells and cause the clinical illness. Primary risk factors for C. difficile clinically apparent infection include antimicrobial therapy, hospitalization, residence in a long-term care facility, older age (≥ 65 years), and increased length of hospital stay. The incidence of CDI both in the hospital and the community is important in the understanding and characterization of the disease and its prevention. This observational, epidemiological study will advance the investigators understanding of CDI risk factors in several hospitals and possibly the community in the Asia Pacific region.