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Clostridium Infections clinical trials

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NCT ID: NCT04003818 Terminated - Clinical trials for Clostridium Difficile Infection-associated Diarrhea and Colitis

Efficacy and Safety of Teicoplanin in CDAD

Start date: May 15, 2020
Phase: Phase 4
Study type: Interventional

Primary Objective: Explore the efficacy of teicoplanin (100-200 mg administered orally twice a day for 7 to 14 days) in patients with Clostridium difficile infection-associated diarrhea and colitis Secondary Objective: Evaluate the safety of teicoplanin in patients with Clostridium difficile infection-associated diarrhea and colitis

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: NCT03988855 Recruiting - Clinical trials for Clostridium Difficile (C. Difficile)

An Exploratory, Open-Label, Oligo-Center Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Intravenous DNV3837 in Subjects With Clostridium Difficile Infection

Start date: August 2, 2019
Phase: Phase 2
Study type: Interventional

This is an open-label study to evaluate the safety, efficacy, and PK of DNV3837 at a dose of 1.5 mg/kg actual body weight(BW)/day administered via IV infusion in subjects with CDI. The study will be conducted in 2 subsequent parts. In Part 1 of the study, 10 subjects of either sex with severe or non-severe CDI will be enrolled to receive DNV3837. In Part 2 of the study, up to 30 subjects with severe or non-severe CDI will be enrolled to receive DNV3837. In both parts of the study, treatment infusions will be administered at a constant rate resulting in a total IV infusion duration of 6 hours per day, for a total maximum daily dose of 120 mg DNV3837. Infusions will be administered once daily for 10 consecutive days. The objectives of the study are: - To evaluate the safety of intravenous (IV) DNV3837; - To evaluate the efficacy of IV DNV3837; - To assess the pharmacokinetics (PK) of DNV3837 and DNV3681 in plasma and of DNV3681 in urine and feces; - To assess C. difficile using microbiological assessments; - To assess the proportion of subjects colonized with vancomycin-resistant enterococci (VRE), extended-spectrum beta-lactamase (ESBL) organisms, or carbapenem-resistant Enterobacteriaceae (CRE) in feces; and - To assess changes in the fecal microbiome using 16S ribosomal ribonucleic acid (RNA) analysis

NCT ID: NCT03973697 Terminated - Clinical trials for Recurrent Clostridium Difficile Infection

Penn Microbiome Therapy for Recurrent Clostridium Difficile Infection

Start date: January 13, 2020
Phase: Phase 2
Study type: Interventional

This is a randomized, open label, comparative, Phase II study to determine which dose of fecal microbiota transplant using Penn Microbiome Therapy (PMT) products is most effective in treating and preventing recurrence of Clostridium difficile infection (C diff).

NCT ID: NCT03970200 Terminated - Clinical trials for Severe-Complicated/Fulminant Clostridium Difficile Infection

Penn Microbiome Therapy (PMT) for Severe-Clostridium Difficile Infection (CDI)

Start date: January 16, 2020
Phase: Phase 2
Study type: Interventional

This is a randomized, open label, comparative, Phase II study to determine whether fecal microbiota transplant using Penn Microbiome Therapy products helps standard therapy to treat severe Clostridium difficile infection (C diff).

NCT ID: NCT03964844 Recruiting - Clinical trials for C.Difficile Diarrhea

Clostridium Difficile Infection (CDI) in Hematologic Patients.

Start date: January 1, 2019
Phase:
Study type: Observational

The microbiology department prospectively generates a data base of all episodes of Clostridium difficile infection (CDI) in the institution, the investigators will analyse the evolution of the episodes and the incidence per 10,000 days of stay of cases of diagnosed CDI in the Hematological wards and the rest of the hospital during the 2006-2018 period. The investigators will also compare the impact on haematological paediatric population. In order to analyse the clinical and epidemiological characteristics of CDI in this population, a case and control study will be conducted, reviewing the medical records of patients who have had an episode of diarrhoea caused by C. difficile in an hematological unit, which will be compared with non-hematological patients who have had an CDI episode These patients will be selected randomly from the Microbiology Department database. The sample size will be 400 patients, 200 per arm. The histories will be reviewed according to a pre-established clinical protocol including epidemiological, clinical, therapeutic and evolution variables. A prospective study in 2019-2020 will also be conducted. The investigators will include all patients diagnosed with an hematological/oncological disease or with any immunosuppressive condition, who have a positive detection of toxigenic Clostridium difficile. Patients will be followed for at least 2 months. For each patient a protocol data will be filled prospectively.

NCT ID: NCT03937999 Terminated - Clinical trials for Clostridium Difficile

Bezlotoxumab as Secondary Prophylaxis for C. Difficile in High-risk Hospitalized Patients Exposed to Antibiotics.

Start date: August 30, 2019
Phase: Phase 4
Study type: Interventional

This study will examine whether the human monoclonal antibody, bezlotoxumab administered AFTER acute Clostridioides difficile (C.diff) has resolved, but during a period of subsequent antibiotic therapy, will eliminate the high risk of C. diff relapse.

NCT ID: NCT03931941 Completed - Infection Clinical Trials

Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCH CD3-OLS)

CD3-OLS
Start date: July 30, 2019
Phase: Phase 3
Study type: Interventional

This is a prospective, multicenter, open-label Phase 3 study of a microbiota suspension of intestinal microbes. Patients who have had at least one recurrence of CDI after a primary episode and have completed at least one round 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. Subjects may receive a second RBX2660 enema if they are deemed treatment failures following the initial enema per the protocol-specified treatment failure definition.

NCT ID: NCT03925636 Completed - Diet Modification Clinical Trials

Specific Carbohydrate Diet for Clostridium Difficile

SCD_cDiff
Start date: June 8, 2016
Phase: N/A
Study type: Interventional

The investigators are doing this research study to answer questions about a nutritional therapy called the Specific Carbohydrate Diet (SCD) for children with active Clostridium Difficile Infection. For this study, the investigators will be looking to determine: 1. Is SCD effective for the treatment for Clostridium Difficile Colonization? 2. Is the SCD well tolerated?

NCT ID: NCT03918629 Completed - Clinical trials for Clostridium Difficile Associated Disease

Clostridium Difficile Vaccine 2-Dose Versus 3-Dose Study

Start date: April 1, 2019
Phase: Phase 3
Study type: Interventional

This study will investigate a Clostridium difficile vaccine in adults 50 years of age and older. In half the adults, all 3 doses given are the Clostridium difficile vaccine, and in half the adults, 2 of the 3 doses are the Clostridium difficile vaccine with the other dose containing no active ingredients. The study will look at the subjects' immune response to the vaccine and assess the safety and tolerability of a 2-dose regimen of Clostridium difficile vaccine compared to a 3-dose regimen of Clostridium difficile vaccine.