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Clinical Trial Name -A Trial to Compare Xifaxan to Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)

 
Original Study ID : RFCL3001
NCT ID : NCT00269399
Brief Title : A Trial to Compare Xifaxan to Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)
Official Title : A Double-Blind, Randomized, Controlled Trial of Rifaximin Compared to Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)
Brief Summary : 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).
Source : Salix Pharmaceuticals
Detailed Description :
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.
Overall Status : Completed
Start Date : December 2005
End Date : December 2008
Completion Date : December 2008
Official Title : Phase 3
Phase : Interventional
Study Design : Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment
Enrollment : 300
Verification Date : March 2009
First Received Date : December 22, 2005
Trial Eligibility
Criteria :
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.
Gender : Both
Minimum Age : 18 Years
Maximum Age : N/A
Healthy Volunteers : No
Facilities
Facility Name : Mayo Clinic Scottsdale
City : Scottsdale
State : Arizona
Zip Code : 85259
Country : United States
Facility Name : Inland Empire Digestive & Liver Diseases
City : Redlands
State : California
Zip Code : 92373
Country : United States
Facility Name : Gastroenterology of the Rockies
City : Longmont
State : Colorado
Zip Code : 80501
Country : United States
Facility Name : Connecticut Gastroenterology Institute
City : Bristol
State : Connecticut
Zip Code : 06010-0977
Country : United States
Facility Name : The George Washington University Medical Center
City : Washington
State : District of Columbia
Zip Code : 20037
Country : United States
Facility Name : Webster Surgical Center LLC
City : Tallahassee
State : Florida
Zip Code : 32308
Country : United States
Facility Name : Advanced Medical Research Center
City : Port Orange
State : Florida
Zip Code : 32127
Country : United States
Facility Name : Halifax Medical Center
City : Daytona Beach
State : Florida
Zip Code : 32114
Country : United States
Facility Name : Southeast Regional Research Group
City : Columbus
State : Georgia
Zip Code : 31904
Country : United States
Facility Name : Digestive Healthcare of Georgia
City : Atlanta
State : Georgia
Zip Code : 30309
Country : United States
Facility Name : Sky Blue, M.D.
City : Boise
State : Idaho
Zip Code : 83712
Country : United States
Facility Name : Gastroenterology, Ltd.
City : Peoria
State : Illinois
Zip Code : 61602
Country : United States
Facility Name : Springfield Clinic
City : Springfield
State : Illinois
Zip Code : 62701
Country : United States
Facility Name : Memorial Medical Center
City : Springfield
State : Illinois
Zip Code : 62702
Country : United States
Facility Name : Carle Clinic Association NCW5
City : Urbana
State : Illinois
Zip Code : 61801
Country : United States
Facility Name : The University of Chicago
City : Chicago
State : Illinois
Zip Code : 60637
Country : United States
Facility Name : Howard Brown Health Center
City : Chicago
State : Illinois
Zip Code : 60613
Country : United States
Facility Name : Iowa Digestive Disease Center, PC
City : Des Moines
State : Iowa
Zip Code : 50312-5300
Country : United States
Facility Name : Kansas Medical Clinic
City : Topeka
State : Kansas
Zip Code : 66606
Country : United States
Facility Name : GI Specialists
City : Olathe
State : Kansas
Zip Code : 66061
Country : United States
Facility Name : Gastrointestinal Associates
City : Overland Park
State : Kansas
Zip Code : 66212
Country : United States
Facility Name : Center for Clinical Research at Washington County Hospital
City : Hagerstown
State : Maryland
Zip Code : 21740
Country : United States
Facility Name : Chevy Chase Clinical Research
City : Chevy Chase
State : Maryland
Zip Code : 20815
Country : United States
Facility Name : Shah Associates
City : Prince Frederick
State : Maryland
Zip Code : 20678
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City : Baltimore
State : Maryland
Zip Code : 21201
Country : United States
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City : Baltimore
State : Maryland
Zip Code : 21201
Country : United States
Facility Name : Arnold Markowitz, MD, PC
City : Keego Harbor
State : Michigan
Zip Code : 48320
Country : United States
Facility Name : Newland Medical Association
City : Southfield
State : Michigan
Zip Code : 48075
Country : United States
Facility Name : Henry Ford Hospital
City : Detroit
State : Michigan
Zip Code : 48202
Country : United States
Facility Name : Mayo Clinic Rochester
City : Rochester
State : Minnesota
Zip Code : 55905
Country : United States
Facility Name : St. Mary's/Duluth Clinic Health System
City : Duluth
State : Minnesota
Zip Code : 55805
Country : United States
Facility Name : Infectious Disease - Minneapolis Ltd.
City : Minneapolis
State : Minnesota
Zip Code : 55422
Country : United States
Facility Name : Minneapolis VAMC
City : Minneapolis
State : Minnesota
Zip Code : 55417
Country : United States
Facility Name : Digestive Health Specialists, PA
City : Tupelo
State : Mississippi
Zip Code : 38801
Country : United States
Facility Name : Deaconess Billings Clinic Research
City : Billings
State : Montana
Zip Code : 59101
Country : United States
Facility Name : Infectious Diseases Associates, PC
City : Omaha
State : Nebraska
Zip Code : 68114
Country : United States
Facility Name : Dartmouth Hitchcock Medical Center
City : Lebannon
State : New Hampshire
Zip Code : 03756
Country : United States
Facility Name : The Gastroenterology Group of South Jersey
City : Vineland
State : New Jersey
Zip Code : 08360
Country : United States
Facility Name : Institute for Clinical Research (ICR) at Holy Name Hospital
City : Teaneck
State : New Jersey
Zip Code : 07666
Country : United States
Facility Name : Drs. Scherl, Chessler, Zingler, Spinnel and Meininger
City : Fort Lee
State : New Jersey
Zip Code : 07024
Country : United States
Facility Name : Marlboro Gastroenterology PC
City : Manalapan
State : New Jersey
Zip Code : 07726
Country : United States
Facility Name : St. Michael's Medical Center
City : Newark
State : New Jersey
Zip Code : 07102
Country : United States
Facility Name : Brookdale University Hospital and Medical Center
City : Brooklyn
State : New York
Zip Code : 11212
Country : United States
Facility Name : North Shore Hepatology
City : Manhasset
State : New York
Zip Code : 11030
Country : United States
Facility Name : New York Medical College/Westchester Medical Center
City : Valhalla
State : New York
Zip Code : 10595
Country : United States
Facility Name : AMS Clinical Research
City : Elmira
State : New York
Zip Code : 14905
Country : United States
Facility Name : University of Rochester School of Medicine
City : Rochester
State : New York
Zip Code : 14642
Country : United States
Facility Name : Weill Medical College
City : New York
State : New York
Zip Code : 10021
Country : United States
Facility Name : East Carolina Gastroenterology, PA
City : Jacksonville
State : North Carolina
Zip Code : 28546
Country : United States
Facility Name : Southern Gastroenterology Associates
City : New Bern
State : North Carolina
Zip Code : 28562
Country : United States
Facility Name : Regional Infectious Diseases - Infusion Center
City : Lima
State : Ohio
Zip Code : 45801
Country : United States
Facility Name : Lima Memorial Health System
City : Lima
State : Ohio
Zip Code : 45804
Country : United States
Facility Name : University of Cincinnati
City : Cincinnati
State : Ohio
Zip Code : 45267-0595
Country : United States
Facility Name : Lehigh Valley Hospital
City : Allentown
State : Pennsylvania
Zip Code : 18103
Country : United States
Facility Name : RPS Infectious Diseases
City : West Reading
State : Pennsylvania
Zip Code : 19611
Country : United States
Facility Name : Drexel University College of Medicine
City : Philadelphia
State : Pennsylvania
Zip Code : 19107
Country : United States
Facility Name : University Gastroenterology
City : Providence
State : Rhode Island
Zip Code : 02905
Country : United States
Facility Name : University of Texas Health Sciences Center
City : Houston
State : Texas
Zip Code : 77030
Country : United States
Facility Name : Digestive Disease Associates of Dallas
City : Dallas
State : Texas
Zip Code : 75231
Country : United States
Facility Name : Michael E. DeBakey VA Medical Center
City : Houston
State : Texas
Zip Code : 77030
Country : United States
Facility Name : Infectious Disease Associates of Central Virginia
City : Lynchburg
State : Virginia
Zip Code : 24501
Country : United States
Facility Name : North Pacific Clinical Research
City : Redmond
State : Washington
Zip Code : 98052
Country : United States
Facility Name : Associated Physicians, LLP
City : Madison
State : Wisconsin
Zip Code : 53705
Country : United States
 
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