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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rifaximin Treatment Arm | Experimental | rifaximin 400mg taken 3 times a day |
|
| Vancomycin Comparator Arm | Active Comparator | vancomycin 125mg taken 4 times a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rifaximin (Xifaxan) | Drug |
| ||
| Vancomycin |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Achieving Clinical Success, Where Clinical Success is Defined as Resolution or Improvement of Baseline Signs and Symptoms i.e., Abdominal Pain, Fever, Diarrhea. | Resolution or improvement of baseline signs and symptoms was assessed as
| 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Recurrence-free of Clostridium Difficile-associated Diarrhea (CDAD), After Achieving Clinical Success | Recurrence of CDAD was defined as diarrhea and a positive Clostridium difficile stool toxin assay that occurs after initial clinical success. | 42 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Scottsdale | Scottsdale | Arizona | 85259 | United States | ||
| Inland Empire Digestive & Liver Diseases |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rifaximin Treatment Arm | rifaximin 400mg taken 3 times a day Rifaximin (Xifaxan) |
| FG001 | Vancomycin Comparator Arm | vancomycin 125mg taken 4 times a day |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Redlands |
| California |
| 92373 |
| United States |
| Gastroenterology of the Rockies | Longmont | Colorado | 80501 | United States |
| Connecticut Gastroenterology Institute | Bristol | Connecticut | 06010-0977 | United States |
| The George Washington University Medical Center | Washington D.C. | District of Columbia | 20037 | United States |
| Halifax Medical Center | Daytona Beach | Florida | 32114 | United States |
| Advanced Medical Research Center | Port Orange | Florida | 32127 | United States |
| Webster Surgical Center LLC | Tallahassee | Florida | 32308 | United States |
| Digestive Healthcare of Georgia | Atlanta | Georgia | 30309 | United States |
| Southeast Regional Research Group | Columbus | Georgia | 31904 | United States |
| Sky Blue, M.D. | Boise | Idaho | 83712 | United States |
| Howard Brown Health Center | Chicago | Illinois | 60613 | United States |
| The University of Chicago | Chicago | Illinois | 60637 | United States |
| Gastroenterology, Ltd. | Peoria | Illinois | 61602 | United States |
| Springfield Clinic | Springfield | Illinois | 62701 | United States |
| Memorial Medical Center | Springfield | Illinois | 62702 | United States |
| Carle Clinic Association NCW5 | Urbana | Illinois | 61801 | United States |
| Iowa Digestive Disease Center, PC | Des Moines | Iowa | 50312-5300 | United States |
| GI Specialists | Olathe | Kansas | 66061 | United States |
| Gastrointestinal Associates | Overland Park | Kansas | 66212 | United States |
| Kansas Medical Clinic | Topeka | Kansas | 66606 | United States |
| Baltimore VA Medical Center | Baltimore | Maryland | 21201 | United States |
| University of Maryland | Baltimore | Maryland | 21201 | United States |
| Chevy Chase Clinical Research | Chevy Chase | Maryland | 20815 | United States |
| Center for Clinical Research at Washington County Hospital | Hagerstown | Maryland | 21740 | United States |
| Shah Associates | Prince Frederick | Maryland | 20678 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Arnold Markowitz, MD, PC | Keego Harbor | Michigan | 48320 | United States |
| Newland Medical Association | Southfield | Michigan | 48075 | United States |
| St. Mary's/Duluth Clinic Health System | Duluth | Minnesota | 55805 | United States |
| Minneapolis VAMC | Minneapolis | Minnesota | 55417 | United States |
| Infectious Disease - Minneapolis Ltd. | Minneapolis | Minnesota | 55422 | United States |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
| Digestive Health Specialists, PA | Tupelo | Mississippi | 38801 | United States |
| Deaconess Billings Clinic Research | Billings | Montana | 59101 | United States |
| Infectious Diseases Associates, PC | Omaha | Nebraska | 68114 | United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Drs. Scherl, Chessler, Zingler, Spinnel and Meininger | Fort Lee | New Jersey | 07024 | United States |
| Marlboro Gastroenterology PC | Manalapan | New Jersey | 07726 | United States |
| St. Michael's Medical Center | Newark | New Jersey | 07102 | United States |
| Institute for Clinical Research (ICR) at Holy Name Hospital | Teaneck | New Jersey | 07666 | United States |
| The Gastroenterology Group of South Jersey | Vineland | New Jersey | 08360 | United States |
| Brookdale University Hospital and Medical Center | Brooklyn | New York | 11212 | United States |
| AMS Clinical Research | Elmira | New York | 14905 | United States |
| North Shore Hepatology | Manhasset | New York | 11030 | United States |
| Weill Medical College | New York | New York | 10021 | United States |
| University of Rochester School of Medicine | Rochester | New York | 14642 | United States |
| New York Medical College/Westchester Medical Center | Valhalla | New York | 10595 | United States |
| East Carolina Gastroenterology, PA | Jacksonville | North Carolina | 28546 | United States |
| Southern Gastroenterology Associates | New Bern | North Carolina | 28562 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45267-0595 | United States |
| Regional Infectious Diseases - Infusion Center | Lima | Ohio | 45801 | United States |
| Lima Memorial Health System | Lima | Ohio | 45804 | United States |
| Lehigh Valley Hospital | Allentown | Pennsylvania | 18103 | United States |
| Drexel University College of Medicine | Philadelphia | Pennsylvania | 19107 | United States |
| RPS Infectious Diseases | West Reading | Pennsylvania | 19611 | United States |
| University Gastroenterology | Providence | Rhode Island | 02905 | United States |
| Digestive Disease Associates of Dallas | Dallas | Texas | 75231 | United States |
| Michael E. DeBakey VA Medical Center | Houston | Texas | 77030 | United States |
| University of Texas Health Sciences Center | Houston | Texas | 77030 | United States |
| Infectious Disease Associates of Central Virginia | Lynchburg | Virginia | 24501 | United States |
| North Pacific Clinical Research | Redmond | Washington | 98052 | United States |
| Associated Physicians, LLP | Madison | Wisconsin | 53705 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Modified Intent-to-Treat (MITT) population included all randomized subjects who had acute diarrhea and with a positive C. difficile stool toxin assay within ± 48 hours of screening and received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Rifaximin Treatment Arm | rifaximin 400mg taken 3 times a day Rifaximin (Xifaxan) |
| BG001 | Vancomycin Comparator Arm | vancomycin 125mg taken 4 times a day Vancomycing |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Participants Achieving Clinical Success, Where Clinical Success is Defined as Resolution or Improvement of Baseline Signs and Symptoms i.e., Abdominal Pain, Fever, Diarrhea. | Resolution or improvement of baseline signs and symptoms was assessed as
| Modified Intent-to-Treat (MITT) population included all randomized subjects who had acute diarrhea and with a positive C. difficile stool toxin assay within ± 48 hours of screening and received at least one dose of study drug. | Posted | Count of Participants | Participants | 14 days |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Proportion of Participants Recurrence-free of Clostridium Difficile-associated Diarrhea (CDAD), After Achieving Clinical Success | Recurrence of CDAD was defined as diarrhea and a positive Clostridium difficile stool toxin assay that occurs after initial clinical success. | Participants included in this analysis were restricted to those who experienced initial clinical success at the TOC Visit following the 10-day Treatment Phase. | Posted | Count of Participants | Participants | 42 days |
|
|
42 days
For safety analyses participants are counted based on the treatments received rather than randomization assignment; 120 participants in the rifaximin group and 116 participants in the vancomycin group. Two (2) participants in the vancomycin group are handled differently than as randomized, including 1 participant who did not receive study drug (so excluded from the safety population) and 1 participant counted in the rifaximin group for safety since the subject actually received rifaximin.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rifaximin Treatment Arm | rifaximin 400mg taken 3 times a day Rifaximin (Xifaxan) | 28 | 120 | 6 | 120 | ||
| EG001 | Vancomycin Comparator Arm | vancomycin 125mg taken 4 times a day | 14 | 116 | 2 | 116 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Clostridial infection | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
| |
| Clostridium colitis | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Anemia hemolytic autoimmune | Blood and lymphatic system disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Asymptomatic bacteriuria | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
| |
| Bacteremia | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
| |
| Klebsiella sepsis | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
| |
| Pseudomonas infection | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
| |
| Collapse of lung | Injury, poisoning and procedural complications | MedDRA (8.1) | Non-systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | MedDRA (8.1) | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (8.1) | Non-systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA (8.1) | Non-systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.1) | Non-systematic Assessment |
| |
| Lung meoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.1) | Non-systematic Assessment |
| |
| Neuroendocrine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.1) | Non-systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.1) | Non-systematic Assessment |
| |
| Non-small cell lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.1) | Non-systematic Assessment |
| |
| Renal cell carcinoma stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.1) | Non-systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Chromic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Hydopneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Insomnia | Psychiatric disorders | MedDRA (8.1) | Non-systematic Assessment |
|
Please contact sponsor for details.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Operations | Bausch Health Americas, Inc. | 908-927-0873 | lindsey.mathew@bauschhealth.com |
| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000078262 | Rifaximin |
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|