9 Clinical Trials for Various Conditions
Approximately 65 patients will be entered into this study taking place in North America. The aim of this study is to evaluate the safety, efficacy and absorption of an investigational drug in patients with C. difficile-associated diarrhea (CDAD). All study related care is provided including doctor visits, physical exams, laboratory tests and study medication. Total length of participation is 6 weeks.
All surgical procedures carry with them the risk of infection. Even a minor infection can extend the hospitalization after cardiac surgery. The average minimum increase in length of stay for a single infection is three days. One of the many means used to reduce post-operative infections is the preventative, or "prophylactic", administration of antibiotics just before and just after surgery. Because antibiotics, and for that matter surgery itself, alter the body's natural immune and inflammatory responses and the makeup of the bacteria in the intestine, there is a great deal of scientific interest in using the supplementation of bacteria that naturally reside in the intestine. It is felt that by doing so, the alterations in the immune response may be corrected and the patient better able to fight infections. There are studies using probiotics that have demonstrated a reduction in infection rates in patients undergoing abdominal surgery. Subjects will be patients at high risk for infection including those with any one or more of the following characteristics: over 65 years old, poor heart function (ejection fraction \<40), diabetes (insulin dependant or non-insulin dependant), peripheral vascular disease, kidney dysfunction (creatinine level \>2mg/dl), obesity (body surface area \> 2 m2), low serum protein levels (albumin \< 2.5 mg/dl), infection of the heart valve (endocarditis), or on any antibiotics other than standard prophylaxis before surgery. The safety of these products has been very well established. Patients who consent to enter the study will receive the synbiotic mix, or a placebo, which comes in a powder that may be mixed with a drink, or washed down into the stomach through the NG tube if the patient is still on a ventilator. Dosing will be initiated within four hours of patient arrival in the Cardiac Surgery Intensive Care Unit and will continue on a twice daily basis for the duration of their admission days. Infection and diarrhea data will be monitored.
The 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.
The investigators propose to study intensively the bacteriology of feces in C. difficile associated diarrheal disease, using a variety of conventional and very up-to-date techniques.
The 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.
The purpose of this study is three fold: 1)To collect serum from patients with documented Clostridium difficile infection and test for the presence of antibody to C. difficile toxin at the start and at the end of therapy, and again if a relapse or recurrence occurs. 2)To collect stool samples for test of C. difficile toxin at similar time intervals. 3)To assay random serum samples from the VA lab in order to determine the rate of antibody to C. difficile toxin in our patient population.
In this record review study, our objective is to determine the rates of cure, failure and relapse following treatment of C. difficile colitis with metronidazole.
The 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.
Approximately 520 patients will be entered into this study taking place throughout the US and Canada. 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. Total length of participation is approximately 6 weeks.