Clostridium InfectionsPhase 3NCT00269399
A Trial to Compare Xifaxan to Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)
A Phase 3 study testing Rifaximin (Xifaxan) and Vancomycin in people with Clostridium Infections and Diarrhea, run by Bausch Health Americas, Inc. at 63 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridium Infections, Diarrhea
- What is being tested?
- Rifaximin (Xifaxan) and Vancomycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 237 participants
- Where
- 63 sitesUnited States
- Study dates
- Dec 2005to Dec 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
63 sites in 1 country.
63 sites in 1 country
United States63 sites
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103
Digestive Healthcare of Georgia
Atlanta, Georgia, 30309
Baltimore VA Medical Center
Baltimore, Maryland, 21201
University of Maryland
Baltimore, Maryland, 21201
Deaconess Billings Clinic Research
Billings, Montana, 59101
Sky Blue, M.D.
Boise, Idaho, 83712
Connecticut Gastroenterology Institute
Bristol, Connecticut, 06010-0977
Brookdale University Hospital and Medical Center
Brooklyn, New York, 11212
Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815
Howard Brown Health Center
Chicago, Illinois, 60613
The University of Chicago
Chicago, Illinois, 60637
University of Cincinnati
Cincinnati, Ohio, 45267-0595
Southeast Regional Research Group
Columbus, Georgia, 31904
Digestive Disease Associates of Dallas
Dallas, Texas, 75231
Halifax Medical Center
Daytona Beach, Florida, 32114
Iowa Digestive Disease Center, PC
Des Moines, Iowa, 50312-5300
Henry Ford Hospital
Detroit, Michigan, 48202
St. Mary's/Duluth Clinic Health System
Duluth, Minnesota, 55805
AMS Clinical Research
Elmira, New York, 14905
Drs. Scherl, Chessler, Zingler, Spinnel and Meininger
Fort Lee, New Jersey, 07024
Center for Clinical Research at Washington County Hospital
Hagerstown, Maryland, 21740
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030
University of Texas Health Sciences Center
Houston, Texas, 77030
East Carolina Gastroenterology, PA
Jacksonville, North Carolina, 28546
Arnold Markowitz, MD, PC
Keego Harbor, Michigan, 48320
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Regional Infectious Diseases - Infusion Center
Lima, Ohio, 45801
Lima Memorial Health System
Lima, Ohio, 45804
Gastroenterology of the Rockies
Longmont, Colorado, 80501
Infectious Disease Associates of Central Virginia
Lynchburg, Virginia, 24501
Associated Physicians, LLP
Madison, Wisconsin, 53705
Marlboro Gastroenterology PC
Manalapan, New Jersey, 07726
North Shore Hepatology
Manhasset, New York, 11030
Minneapolis VAMC
Minneapolis, Minnesota, 55417
Infectious Disease - Minneapolis Ltd.
Minneapolis, Minnesota, 55422
Southern Gastroenterology Associates
New Bern, North Carolina, 28562
Weill Medical College
New York, New York, 10021
St. Michael's Medical Center
Newark, New Jersey, 07102
GI Specialists
Olathe, Kansas, 66061
Infectious Diseases Associates, PC
Omaha, Nebraska, 68114
Gastrointestinal Associates
Overland Park, Kansas, 66212
Gastroenterology, Ltd.
Peoria, Illinois, 61602
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19107
Advanced Medical Research Center
Port Orange, Florida, 32127
Shah Associates
Prince Frederick, Maryland, 20678
University Gastroenterology
Providence, Rhode Island, 02905
Inland Empire Digestive & Liver Diseases
Redlands, California, 92373
North Pacific Clinical Research
Redmond, Washington, 98052
Mayo Clinic Rochester
Rochester, Minnesota, 55905
University of Rochester School of Medicine
Rochester, New York, 14642
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259
Newland Medical Association
Southfield, Michigan, 48075
Springfield Clinic
Springfield, Illinois, 62701
Memorial Medical Center
Springfield, Illinois, 62702
Webster Surgical Center LLC
Tallahassee, Florida, 32308
Institute for Clinical Research (ICR) at Holy Name Hospital
Teaneck, New Jersey, 07666
Kansas Medical Clinic
Topeka, Kansas, 66606
Digestive Health Specialists, PA
Tupelo, Mississippi, 38801
Carle Clinic Association NCW5
Urbana, Illinois, 61801
New York Medical College/Westchester Medical Center
Valhalla, New York, 10595
The Gastroenterology Group of South Jersey
Vineland, New Jersey, 08360
The George Washington University Medical Center
Washington D.C., District of Columbia, 20037
RPS Infectious Diseases
West Reading, Pennsylvania, 19611
About this study
Official title: A Double-Blind, Randomized, Controlled Trial of Rifaximin Compared 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).
Read the 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.
- Conditions
- Clostridium Infections, Diarrhea
- Being tested
- Rifaximin (Xifaxan), Vancomycin
- Keywords
- Clostridium difficile-associated Diarrhea (CDAD), CDAD, C diff
- Medical subject headings
- Clostridium Infections, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rifaximin (Xifaxan)Drug
VancomycinDrug
| Study group | Role | What they receive |
|---|---|---|
| Rifaximin Treatment Arm | Experimental | rifaximin 400mg taken 3 times a day Receives: Drug: Rifaximin (Xifaxan) |
| Vancomycin Comparator Arm | Active comparator | vancomycin 125mg taken 4 times a day Receives: Drug: Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- Absence of severe abdominal pain for 2 consecutive days at the test of cure (TOC) Visit (Day 14 +/-1);
- Absence of fever (< 38°C/100.4°F) for 2 consecutive days at the TOC Visit; and
- 3 unformed (loose or watery) stools per day for at least 48 hours that was sustained through the TOC Visit.
Measured: 14 days
Secondary outcomes (1)
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.
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2005 (estimated)
- Study startDec 2005
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Clostridium InfectionsStudies of the same condition, open and under way.
- More trials run by Bausch Health Americas, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00269399
- Sponsor's protocol ID
- RFCL3001
- Status last verified
- Sep 2019
- First submitted
- 22 Dec 2005
- Last updated
- 14 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Controlled Trial of Rifaximin Compared to Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)
- ClinicalTrials.gov ID
- NCT00269399
- Acronym / sponsor ID
- RFCL3001
- Conditions
- Clostridium Infections, Diarrhea
- Keywords
- Clostridium difficile-associated Diarrhea (CDAD), CDAD, C diff
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 23 Dec 2005 (estimated)
- Results
- Posted 1 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rifaximin Treatment Arm | Experimental | Drug: Rifaximin (Xifaxan)rifaximin 400mg taken 3 times a day |
| Vancomycin Comparator Arm | Active comparator | Drug: Vancomycinvancomycin 125mg taken 4 times a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rifaximin (Xifaxan) | Drug | Rifaximin Treatment Arm |
| Vancomycin | Drug | Vancomycin Comparator Arm |
Primary outcome
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.
Time frame: 14 days
Resolution or improvement of baseline signs and symptoms was assessed as * Absence of severe abdominal pain for 2 consecutive days at the test of cure (TOC) Visit (Day 14 +/-1); * Absence of fever (< 38°C/100.4°F) for 2 consecutive days at the TOC Visit; and * 3 unformed (loose or watery) stools per day for at least 48 hours that was sustained through the TOC Visit.
1 secondary outcome
Proportion of Participants Recurrence-free of Clostridium Difficile-associated Diarrhea (CDAD), After Achieving Clinical Success
Time frame: 42 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
63 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rifaximin (Xifaxan) and Vancomycin in people with Clostridium Infections and Diarrhea, run by Bausch Health Americas, Inc. at 63 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 63 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2019; AzTrials last refreshed its copy on 7 Nov 2026.