A Study of the Absorption of GT267-004 in Patients With Clostridium Difficile-Associated Diarrhea...
Pseudomembranous ColitisClostridium Difficile Diarrhea1 moreApproximately 24 patients will be entered into this study taking place in Canada. The aim of this study is to determine if an investigational drug is absorbed (taken up) in patients with C. difficile-associated diarrhea (CDAD). The investigational drug will be given in addition to current standard antibiotic treatment so that all patients will receive active medication. All study related care is provided including doctor visits, physical exams, laboratory tests, and study medication. The total length of participation is approximately 7 days.
Compassionate Use of Nitazoxanide for the Treatment of Clostridium Difficile Infection
Clostridium EnterocolitisPseudomembranous ColitisThe purpose of this study is for compassionate use of nitazoxanide in the treatment of diarrheal disease due to Clostridium difficile infection when the patient has failed previous treatment with metronidazole or vancomycin.
A Study of GT267-004 Versus Vancomycin and GT267-004 Versus Metronidazole in Patients With C. Difficile-Associated...
Clostridium EnterocolitisDiarrheaApproximately 520 patients will be entered into this study taking place throughout Australia and Europe. This study aims to determine if an investigational drug is safe and effective for treating symptoms of C. difficile-associated diarrhea (CDAD) and lowering the risk of repeat episodes of CDAD. The investigational drug will be evaluated in comparison to current standard antibiotic treatment, so all patients will receive active medication. All study related care is provided including doctor visits, physical exams, laboratory tests, and study medication. The total length of participation is approximately 6 weeks.
Efficacy of Metronidazole Versus Metronidazole and Rifampin in CDAD Treatment
Clostridium EnterocolitisAntibiotic-Associated Diarrhea3 moreWhat is the difference between the use of one drug (Oral Metronidazole) versus the use of this same drug combined with another drug (Rifampin) in treatment of bacteria and infection-associated diarrhea in patients? This infection is an important cause of morbidity and mortality in both the community and hospitals, and the leading cause of hospital and chronic facility-acquired diarrhea. Research is important for the treatment of this infection. Patient care with use of two medication treatment regimens will be studied.
Addition of Lactobacillus to Metronidazole in Treatment of CDAD
EnterocolitisPseudomembranous Colitis1 moreThe purpose of this study is to determine whether dietary supplementation with Lactobacillus GG will reduce the rate of failure or relapse following treatment of CDAD with metronidazole.
Bezlotoxumab Versus FMT for Multiple Recurrent CDI
Clostridium InfectionsClostridioides Difficile2 moreThe objective of this trial is to investigate whether a treatment strategy offering bezlotoxumab before FMT in patients suffering from multiple recurrent CDI results in equal efficacy compared with a treatment strategy with initial FMT. Strategy A includes bezlotoxumab as ancillary treatment as first option, and FMT in case of failure. Option B includes FMT as ancillary treatment as first option, and antibiotic treatment with fidaxomicin in case of failure. A secondary objective is to provide a point estimate of recurrence after bezlotoxumab for the treatment of multiple recurrent CDI.
Extended Treatment With Vancomycin for Clostridium Difficile Colitis
Clostridium Difficile ColitisBACKGROUND: Clostridium difficile-associated colitis is an infection of the large bowel, usually associated with previous use of antibiotics. The disease course may be complicated by fulminant disease requiring removal of the colon or by multiple recurrences requiring re-hospitalization. The incidence and severity of Clostridium difficile infection is rising, and it poses an increasing burden on the health system. For example, in one of our previous studies we found that 804 in-patients and 568 out-patients had a positive test for Clostridium difficile toxin at Beaumont Laboratories in 2003. The standard treatment is a 2 week course of Vancomycin or Metronidazole. The clinical response to Metronidazole appears to be declining, and many practicing clinicians prefer Vancomycin as a first-line treatment. The recurrence rate after the treatment is similar for Vancomycin and Metronidazole and is usually in the range of 15-25%, although recent reports noted a recurrence rate up to 50% during outbreaks with a virulent strain. Recently, it has been suggested that a 2 week duration of treatment might not be adequate in clearing the infection. Our HYPOTHESIS is that a prolongation of Vancomycin treatment from 2 weeks to 4 weeks will lead to a decrease rate of recurrent Clostridium Difficile colitis.
Effect of Probiotic Lactobacilli (Lacidofil Cap®) for the Prevention of Antibiotic-Associated Diarrhea...
Antibiotics Associated ColitisPulmonary InfectionAntibiotic-Associated Diarrhea (AAD) is a common complication of antibiotic use. The frequency of AAD can be high (26 - 60%) or moderate (13-29%) during hospital outbreaks and is relatively infrequent in outpatients. The risk factors for AAD include broad-spectrum antibiotics, host factors (age, health status, and gender), hospitalization period and exposure to nosocomial pathogens. AAD occurs 2-8 weeks after exposure to antibiotics as a result of disrupting normal intestinal microflora. One of the roles of normal intestinal microflora is to act as a protective barrier that resists the colonization of intestinal pathogens. These patients are susceptible to infection by opportunistic pathogens without this protective barrier. Probiotic therapy is suited to AAD and Clostridium difficile disease. Probiotics assist in reestablishing the disrupted intestinal microflora, enhancing immune responses and clearing pathogens and their toxins from the host. Studies using probiotics have been reported for the past twenty-eight years (1977~2005), but the studies have been variable in trial designs and types of probiotics, had differing doses and durations of treatment, and thus have yielded controversial results. The investigators will conduct a multi-center, randomized, placebo-controlled, double-blind trial to assess the efficacy of the probiotic Lactobacilli (Lacidofil cap®) for the prevention of AAD in adults.
Vancomycin vs. Nitazoxanide to Treat Recurrent C. Difficile Colitis
Clostridium EnterocolitisPseudomembranous Colitis1 moreThe purpose of this study is to compare the outcome of treatment with nitazoxanide vs. vancomycin for diarrheal disease due to Clostridium difficile in patients who have failed previous treatment with metronidazole.
Response of Clostridium Difficile Infection to Metronidazole Therapy
Clostridium EnterocolitisPseudomembranous Colitis1 moreIn this record review study, our objective is to determine the rates of cure, failure and relapse following treatment of C. difficile colitis with metronidazole.