A Trial to Compare Xifaxan to Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)
A Trial to Compare Xifaxan to Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)
The purpose of this study is to assess the treatment and safety of a 10-day course of
 rifaximin (Xifaxan) as compared to vancomycin for treatment of Clostridium
 difficile-associated diarrhea (CDAD).
Clostridium difficile is a bacterium that proliferates when normal colonic flora have been
 altered, most commonly due to antibiotic use. Clostridium difficile is non-invasive and
 localized to the lumen of the colon. Once established, it produces 2 potent toxins, A and B.
 The principal reservoir for Clostridium difficile is the hospital environment, with the risk
 of acquiring Clostridium difficile increasing in direct proportion to the length of hospital
 stay.

 Patients with CDAD typically present with profuse watery or mucoid diarrhea and cramping
 abdominal pain. Additional symptoms include fever, nausea, anorexia, malaise, and bloody
 stool. More severe cases may be complicated by dehydration, electrolyte disturbances, ileus,
 and peritonitis. Systemic manifestations may include prerenal azotemia, sepsis syndrome, and
 toxic colitis. White blood cell counts (WBCs) also may be markedly elevated with a shift to
 immature forms. Extreme presentation of fulminant colitis may require a colectomy and even
 result in death. Symptoms of CDAD may begin a few days after initiation of antibiotic therapy
 or up to 8 weeks after its discontinuation.
Inclusion Criteria:

 -  Subject is 18 years of age or older, has acute diarrhea and at least 1 other sign of
 enteric infection present, such as fever, nausea/loss of appetite, vomiting, severe
 abdominal pain or discomfort.

 -  Subject has a positive Clostridium difficile stool toxin assay at screening

 Exclusion Criteria:

 -  Subject has had a previous episode of clinically diagnosed Clostridium difficile
 within the past 6 months.

 -  Subject has chronic diseases associated with diarrhea (e.g., inflammatory bowel
 disease or diarrhea predominant irritable bowel syndrome [DIBS])

 -  Subject has had any therapy with any agent administered for the treatment of
 Clostridium difficile prior to randomization.