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

Condition(s) targeted: Clostridium Infections; Diarrhea

Intervention: Rifaximin (Xifaxan) (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Salix Pharmaceuticals

Overall contact:
Audrey Shaw, Phone: 919-447-3176, Email: audrey.shaw@salix.com

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).

Official title: A Double-Blind, Randomized, Controlled Trial of Rifaximin Compared to Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment

Primary outcome: The primary endpoint is the proportion of subjects achieving clinical success, where clinical success is defined as resolution or improvement of baseline signs and symptoms i.e., abdominal pain, fever, diarrhea.

Secondary outcome: The secondary endpoint will be the proportion of subjects who have a recurrence of CDAD, with recurrence defined as diarrhea and a positive Clostridium difficile stool toxin assay that occurs after initial clinical success.

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Audrey Shaw, Phone: 919-447-3176, Email: audrey.shaw@salix.com

Mayo Clinic Scottsdale, Scottsdale, Arizona 85259, United States; Terminated

Inland Empire Digestive & Liver Diseases, Redlands, California 92373, United States; Terminated

Gastroenterology of the Rockies, Longmont, Colorado 80501, United States; Recruiting
David Gatof, MD, Phone: 303-702-5900, Email: david.gatof@gastrorockies.com
Sandy Brubaker, Phone: 303-604-5000, Email: bru8069@aol.com
David Gatof, MD, Principal Investigator

Connecticut Gastroenterology Institute, Bristol, Connecticut 06010-0977, United States; Recruiting
Salam Zakko, MD FACP, Phone: 860-585-3838, Email: szakko@bristolhospital.org
M. Cecile Guttermuth, PhD, Phone: 860-585-3838, Email: cgutterm@bristolhospital.org
Salam Zakko, MD FACP, Principal Investigator

The George Washington University Medical Center, Washington, District of Columbia 20037, United States; Recruiting
David Parenti, MD, Phone: 202-741-2234, Email: dparenti@mfa.gwu.edu
Aimee Desrosiers, PA-C, Phone: 202-741-2443, Email: adesrosiers@mfa.gwu.edu
David Parenti, MD, Principal Investigator

Webster Surgical Center LLC, Tallahassee, Florida 32308, United States; Terminated

Advanced Medical Research Center, Port Orange, Florida 32127, United States; Recruiting
Ammar Hemaidan, MD, Phone: 386-763-4920, Email: ahemaidan@aol.com
Svetlana Klycheva, PhD, CRC, Phone: 386-481-6671, Email: svetlana1965@earthlink.net
Ammar Hemaidan, MD, Principal Investigator

Halifax Medical Center, Daytona Beach, Florida 32114, United States; Recruiting
Ammar Hemaidan, MD, Phone: 386-763-4920, Email: ahemaidan@aol.com
Svetlana Klycheva, PhD, CRC, Phone: 386-481-6671, Email: svetlana1965@earthlink.net
Ammar Hemaidan, MD, Principal Investigator

Southeast Regional Research Group, Columbus, Georgia 31904, United States; Terminated

Digestive Healthcare of Georgia, Atlanta, Georgia 30309, United States; Terminated

Sky Blue, M.D., Boise, Idaho 83712, United States; Terminated

Gastroenterology, Ltd., Peoria, Illinois 61602, United States; Terminated

Springfield Clinic, Springfield, Illinois 62701, United States; Recruiting
Donald Graham, MD, Phone: 217-527-4744, Email: research@springfieldclinic.com
Sharon Waters, Phone: 217-535-2096, Email: research@springfieldclinic.com
Donald Graham, MD, Principal Investigator

Memorial Medical Center, Springfield, Illinois 62702, United States; Recruiting
Donald Graham, MD, Phone: 217-527-4744, Email: research@springfieldclinic.com
Sharon Waters, Phone: 217-535-2096, Email: research@springfieldclinic.com
Donald Graham, MD, Principal Investigator

Carle Clinic Association NCW5, Urbana, Illinois 61801, United States; Recruiting
Eugene Greenberg, MD FACP FACG, Phone: 217-383-3610, Email: eugene.greenberg@carle.com
Micki Suits, RN, Phone: 217-326-0058, Email: micki.suits@carle.com
Eugene Greenberg, MD FACP FACG, Principal Investigator

The University of Chicago, Chicago, Illinois 60637, United States; Recruiting
David Rubin, MD, Phone: 773-702-2950, Email: drubin@medicine.bsd.uchicago.edu
Bonnie Surma, RN, Phone: 773-702-5055, Email: bsurma@medicine.bsd.uchicago.edu
David Rubin, MD, Principal Investigator

Howard Brown Health Center, Chicago, Illinois 60613, United States; Terminated

Iowa Digestive Disease Center, PC, Des Moines, Iowa 50312-5300, United States; Terminated

Kansas Medical Clinic, Topeka, Kansas 66606, United States; Terminated

GI Specialists, Olathe, Kansas 66061, United States; Terminated

Gastrointestinal Associates, Overland Park, Kansas 66212, United States; Terminated

Center for Clinical Research at Washington County Hospital, Hagerstown, Maryland 21740, United States; Terminated

Chevy Chase Clinical Research, Chevy Chase, Maryland 20815, United States; Recruiting
Robert Hardi, MD, Phone: 301-652-5520, Email: robidoc@aol.com
Susie Milton, BS CCRC, Phone: 301-652-5520, Email: susanna.milton@metrogastro.com
Robert Hardi, MD, Principal Investigator

Shah Associates, Prince Frederick, Maryland 20678, United States; Recruiting
Atul Shah, MD, Phone: 410-535-4333, Email: avni@erols.com
Melissa Harris, Phone: 410-535-4333, Email: lissielis@netzero.net
Atul Shah, MD, Principal Investigator

University of Maryland, Baltimore, Maryland 21201, United States; Recruiting
Graeme Forrest, MD, Phone: 410-706-7560, Email: gforrest@medicine.umaryland.edu
Myra James, Phone: 410-605-7000, Ext: 5556, Email: myra.james@va.gov
Graeme Forrest, MD, Principal Investigator

Baltimore VA Medical Center, Baltimore, Maryland 21201, United States; Recruiting
Graeme Forrest, MD, Phone: 410-706-7560, Email: gforrest@medicine.umaryland.edu
Myra James, Phone: 410-605-7000, Ext: 5556, Email: myra.james@va.gov
Graeme Forrest, MD, Principal Investigator

Arnold Markowitz, MD, PC, Keego Harbor, Michigan 48320, United States; Terminated

Newland Medical Association, Southfield, Michigan 48075, United States; Terminated

Henry Ford Hospital, Detroit, Michigan 48202, United States; Terminated

Mayo Clinic Rochester, Rochester, Minnesota 55905, United States; Recruiting
Darrell Pardi, MD, Phone: 507-538-1231, Email: pardi.darrell@mayo.edu
Patricia Kammer, CCRP, Phone: 507-538-1827, Email: kammer.patricia@mayo.edu
Darrell Pardi, MD, Principal Investigator

St. Mary's/Duluth Clinic Health System, Duluth, Minnesota 55805, United States; Terminated

Infectious Disease - Minneapolis Ltd., Minneapolis, Minnesota 55422, United States; Terminated

Minneapolis VAMC, Minneapolis, Minnesota 55417, United States; Terminated

Digestive Health Specialists, PA, Tupelo, Mississippi 38801, United States; Terminated

Deaconess Billings Clinic Research, Billings, Montana 59101, United States; Terminated

Infectious Diseases Associates, PC, Omaha, Nebraska 68114, United States; Recruiting
Robert G Penn, MD, Phone: 402-354-8155, Email: robert.penn@nmhs.org
Darcy Jones, PA-C, Phone: 402-354-8155, Email: darcy.jones@nmhs.org
Robert G Penn, MD, Principal Investigator

Dartmouth Hitchcock Medical Center, Lebannon, New Hampshire 03756, United States; Recruiting
Jeffrey Parsonnet, MD, Phone: 603-650-6060, Email: jeffrey.parsonnet@hitchcock.org
Terre Currie, Phone: 603-650-2938, Email: terre.currie@hitchcock.org
Jeffrey Parsonnet, MD, Principal Investigator

The Gastroenterology Group of South Jersey, Vineland, New Jersey 08360, United States; Terminated

Institute for Clinical Research (ICR) at Holy Name Hospital, Teaneck, New Jersey 07666, United States; Recruiting
Thomas Birch, MD, Phone: 201-541-6312, Email: drtmbirch@yahoo.com
Shradda Agarwal, Phone: 201-833-7757, Email: agarwal@mail.holyname.org
Thomas Birch, MD, Principal Investigator

Drs. Scherl, Chessler, Zingler, Spinnel and Meininger, Fort Lee, New Jersey 07024, United States; Recruiting
Mitchell Spinnell, MD, Phone: 201-945-6564, Email: mspinnell@gimeds.com
Andres Solorza, MD, Phone: 201-655-1010, Email: asolorzal@hotmail.com
Mitchell Spinnell, MD, Principal Investigator

Marlboro Gastroenterology PC, Manalapan, New Jersey 07726, United States; Recruiting
Brian Weiner, MD, Phone: 732-972-6996, Email: drweiner@optonline.net
Denise DiPierri, RN, Phone: 732-972-6996, Email: ddipierri@yahoo.com
Brian Weiner, MD, Principal Investigator

St. Michael's Medical Center, Newark, New Jersey 07102, United States; Recruiting
Leon Smith, MD, Phone: 973-877-5482, Email: lgsmithmd@aol.com
James Fallon, Phone: 973-877-2663, Email: jimf@cathedralhealth.org
Leon Smith, MD, Principal Investigator

Brookdale University Hospital and Medical Center, Brooklyn, New York 11212, United States; Terminated

North Shore Hepatology, Manhasset, New York 11030, United States; Terminated

New York Medical College/Westchester Medical Center, Valhalla, New York 10595, United States; Terminated

AMS Clinical Research, Elmira, New York 14905, United States; Terminated

University of Rochester School of Medicine, Rochester, New York 14642, United States; Recruiting
Robert Betts, MD, Phone: 716-275-5871, Email: robert_betts@urmc.rochester.edu
Melissa Khorana, RN, CCRC, Phone: 585-273-4318, Email: melissa_khorana@urmc.rochester.edu
Robert Betts, MS, Principal Investigator

Weill Medical College, New York, New York 10021, United States; Terminated

East Carolina Gastroenterology, PA, Jacksonville, North Carolina 28546, United States; Terminated

Southern Gastroenterology Associates, New Bern, North Carolina 28562, United States; Recruiting
W. Stewart Futch, Jr., MD, Phone: 252-634-9000, Email: geeve@aol.com
Patricia Lewis, Phone: 252-634-9000, Email: fnplewis@yahoo.com
W. Stewart Futch, Jr, MD, Principal Investigator

Regional Infectious Diseases - Infusion Center, Lima, Ohio 45801, United States; Recruiting
R. Scott Stienecker, MD, Phone: 419-228-1535
Frances L Mauk, RNC, Phone: 419-228-1535, Email: franmauk@woh.rr.com
R. Scott Stienecker, MD, Principal Investigator

Lima Memorial Health System, Lima, Ohio 45804, United States; Active, not recruiting

University of Cincinnati, Cincinnati, Ohio 45267-0595, United States; Terminated

Lehigh Valley Hospital, Allentown, Pennsylvania 18103, United States; Recruiting
Marcelo Gareca, MD, Phone: 610-402-1285, Email: marcelo.gareca@lvh.com
Leslie Baga, RN BSN CCRC, Phone: 610-402-1285, Email: leslie.baga@lvh.com
Marcelo Gareca, MD, Principal Investigator

RPS Infectious Diseases, West Reading, Pennsylvania 19611, United States; Terminated

Drexel University College of Medicine, Philadelphia, Pennsylvania 19107, United States; Recruiting
James Reynolds, MD, Phone: 215-762-8397, Email: james.reynolds@drexelmed.edu
Elango P Vinjirayer, MD, Phone: 215-762-6070, Email: elango.vinjirayer@drexelmed.edu
James Reynolds, MD, Principal Investigator

University Gastroenterology, Providence, Rhode Island 02905, United States; Terminated

University of Texas Health Sciences Center, Houston, Texas 77030, United States; Terminated

Digestive Disease Associates of Dallas, Dallas, Texas 75231, United States; Recruiting
Rajeev Jain, MD, Phone: 214-345-6999, Email: rajeevjainmd@gmail.com
Elizabeth Hoang, BA, Phone: 214-345-6849, Email: elizabethhoang@texashealth.org
Rajeev Jain, MD, Principal Investigator

Michael E. DeBakey VA Medical Center, Houston, Texas 77030, United States; Terminated

Infectious Disease Associates of Central Virginia, Lynchburg, Virginia 24501, United States; Recruiting
Robert Brennan, MD, Phone: 434-947-3945, Email: robert.brennan@macvmd.com
Barbara Cassise, Phone: 434-947-3945, Ext: 2135, Email: barbara.cassise@macvmd.com
Robert Brennan, MD, Principal Investigator

North Pacific Clinical Research, Redmond, Washington 98052, United States; Terminated

Monroe Clinic, Monroe, Wisconsin 53566, United States; Recruiting
James Pollock, MD, Phone: 608-324-2291, Email: james.pollock@monroeclinic.org
Patricia Berra, CCRC, Phone: 608-324-2290, Email: ptberra@tds.net
James Pollock, MD, Principal Investigator

Associated Physicians, LLP, Madison, Wisconsin 53705, United States; Terminated

Starting date: December 2005
Last updated: July 26, 2008