View clinical trials related to Clostridium Difficile Infection.
Filter by:The objective is to conduct a prospective, sham controlled, double-blinded, interventional crossover trial to compare standard terminal cleaning plus PX-UV (intervention) with standard terminal cleaning plus sham PX-UV (control) with crossover at 12 months, following a 6-month washout period. Outcome measures include the rates of HAIs, as well as the recurrence of genetically identical clinical strains of HAIs among patients on study units. The study will be conducted in 2 hospitals covering 16 total hospital units at Detroit Medical Center. Our central hypothesis is that the addition of PX-UV to standard terminal cleaning will be associated with a significant reduction in the rate of HAIs, as well as a reduction in the recovery of genetically identical strains of MDROs. The impact of PX-UV disinfection on rates of HAIs on study units will be determined by comparing rates of HAIs on a) study units where PX-UV is added to standard terminal cleaning practices to b) units where a sham UV disinfection system is added to standard terminal cleaning; and by comparing rates of HAIs on the same medical ward during each of two 12-month phases of a crossover study (one phase when a PX-UV device is added and one when a sham device is added to standard terminal cleaning). The long-term goal of this project is to establish the efficacy of terminal cleaning plus PX-UV in reducing rates of HAIs due to the following multi-drug resistant organisms (MDROs): C. difficile, vancomycin-resistant enterococci (VRE), Klebsiella pneumoniae and Escherichia coli producing extended-spectrum beta-lactamases (ESBLs), methicillin-resistant Staphylococcus aureus (MRSA) and Acinetobacter baumannii. At the conclusion of the proposed project, novel data will be generated from this rigorously controlled study regarding the effectiveness of PX-UV in reducing HAIs in a representative, real-world healthcare setting.
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
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.
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.
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.
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.
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.
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.
This study will randomized hematology oncology patients with active diarrhea and a NAAT positive/toxin EIA negative to either 14 days of oral vancomycin capsules or placebo. The study is designed to include 30 patients (15 per arm). Outcomes will include C. difficile load using qPCR, VRE loads, structural and functional microbiome changes and frequency of bowel movements. All endpoints will be measured at several time points including days 0, 14, 21 and 90.
Clostridium difficile is the first cause of nosocomial infectious diarrhea, due to its mode of transmission and its resistance in the environment. Nosocomiality is defined by the apparition of an infection 48 hours after the patient's hospitalization. Clostridium difficile contamination occurs oro-fecally and is transmitted directly through the hand or from the contaminated environment (during care or not). By implementing prevention and optimal treatment, nosocomial infections are preventable. A clostridium difficile infection causes an additional cost of patient care for the hospital. This additional cost is principally due to the increase of the length of the stay. It varies according to patient risk factors,and also according to the reason of the hospitalization and can vary from 300 euros (~317$) to more than 25.000 euros (26.460$). By determining the increase in the length of the stay and the additional cost due to a clostridium difficile infection in the GHICL (Groupement des Hôpitaux de l'Institut Catholique de Lille), prevention will be valued and measures against those infections should be easier to set up. The main objective of this study is to evaluate the additional cost of an infection by clostridium difficile.