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Sponsors and Collaborators: |
University of Massachusetts Medarex |
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Information provided by: | University of Massachusetts |
ClinicalTrials.gov Identifier: | NCT00350298 |
Patients with Clostridium difficile associated disease who fulfill the eligibility criteria will be approached to participate. All study patients must receive standard of care treatment for Clostridium difficile associated disease. Enrolled patients will be randomized to receive a single intravenous solution of a human monoclonal antibody (huMab) to C. difficile toxin A (GS-CDA1) combined with a human monoclonal antibody to C. difficile toxin B (MDX-1388) or 0.9% sodium chloride as placebo in a 1:1 treatment allocation.Patients will be evaluated for safety and clinical outcomes through day 84 +/- 10 days. Occurrence of adverse events, use of concomitant medications, and stool output will be assessed at scheduled phone contacts and study visits. Some patients enrolled will have a subsequent visit on day 168 ± 14 days.
Condition | Intervention | Phase |
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Clostridium Infections |
Biological: GS-CDA1 Biological: MDX-1388 Biological: normal saline |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Randomized, Double-Blind, Placebo-Controlled Study of the Clinical Effectiveness of a Human Monoclonal Antibody to Clostridium Difficile Toxin A (GS-CDA1) and a Human Monoclonal Antibody to Clostridium Difficile Toxin B (MDX-1388) in Patients Being Treated for Clostridium Difficile Associated Disease |
Estimated Enrollment: | 200 |
Study Start Date: | July 2006 |
Estimated Study Completion Date: | July 2008 |
Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
GS-CDA1 and MDX-1388
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Biological: GS-CDA1
one dose IV
Biological: MDX-1388
one dose IV
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2: Placebo Comparator
normal saline (0.9% sodium chloride)
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Biological: normal saline
200ml IV once
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This study is a phase II, randomized, double-blind, placebo-controlled study in patients diagnosed with Clostridium difficile associated disease. Patients with Clostridium difficile associated disease will be identified either from stool test results or by physician referral, and those who fulfill the eligibility criteria will be approached to participate. All study patients must receive standard of care treatment for Clostridium difficile associated disease. Enrolled patients will be randomized to receive a single intravenous solution of a human monoclonal antibody to C. difficile toxin A (GS-CDA1) combined with a human monoclonal antibody to C. difficile toxin B (MDX-1388) or 0.9% sodium chloride as placebo in a 1:1 treatment allocation. One hundred patients will be enrolled in the combination monoclonal antibody treated arm and 100 patients will be enrolled in the placebo arm. Patients will be evaluated through day 84 ± 10 days after receipt of study infusion for safety and clinical outcomes. Blood samples for safety analyses, anti-toxin A and anti-toxin B antibody measurements and human anti-human antibody (HAHA) titers will be collected at scheduled times. Study visits will occur on days 3 ± 1, 10 ± 2, 28 ± 3, 56 ± 7 and on day 84 ± 10 days. Occurrence of adverse events, use of concomitant medications, and record of stool output will be assessed at scheduled phone contacts and study visits. The first 20 patients enrolled will have a subsequent visit on day 168 ± 14 days for an additional blood collection for HAHA analysis.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Roger Baxter, MD | Kaiser Permanente Vaccine Study Center |
Principal Investigator: | Herbert DuPont, MD | St. Lukes Episcopal Hospital, Houston, TX |
Principal Investigator: | Joseph White, MD | Scott and White Memorial Hospital, Temple, TX |
Principal Investigator: | David Chen, MD | MultiCare Health System Research Services, Tacoma, WA |
Principal Investigator: | Jorge Reyno, MD | Rapid City Regional Hospital, Rapid City, SD |
Principal Investigator: | Henry S. Sacks, MD, PhD | Mount Sinai Hospital, New York, NY |
Principal Investigator: | Charles N. Bernstein, MD | University of Manitoba, Health Sciences Centre, Winnepeg, Manitoba, Canada |
Principal Investigator: | Michael J. Tan, MD | Summa Health Systems, Akron, Ohio |
Principal Investigator: | Michael C. Meadors, MD | All-Trials Clinical Research, LLC, Winston-Salem, NC |
Principal Investigator: | Ian M. Baird, MD | Remington-Davis Clinical Research |
Principal Investigator: | Andre Poirier, MD, MSc | Centre Hospitalier Regional de Trois-Rivieres |
Principal Investigator: | Martha I. Buitrago, MD | Idaho Falls Infectious Diseases, PLLC |
Principal Investigator: | Thomas Kovacs, MD | UCLA CURE Digestive Diseases Research Center |
Principal Investigator: | Alfred Bacon, MD | Christiana Care Health Systems |
Principal Investigator: | Kathleen Casey, MD | JERSEY SHORE UNIVERSITY MEDICAL CENTER |
Principal Investigator: | C. Douglas Cochran, MD | Saint Luke's Hospital of Kansas City |
Principal Investigator: | Donald Daly, MD | Vancouver Island Health Research Centre |
Principal Investigator: | Anil Dhar, MBBS | WIndsor Regional Hospital |
Principal Investigator: | Gerald Evans, MD | Kingston General Hospital |
Principal Investigator: | Richard Greenberg, MD | University of Kentucky Medical Center |
Principal Investigator: | Thomas Louie, MD | University of Calgary Foothills Medical Center |
Principal Investigator: | Thomas Nowak, MD | Central Indiana Gastroenterology Group |
Principal Investigator: | Jose Prieto, MD | Dr. Kiran C. Patel Research Institute |
Principal Investigator: | Daniel Schroeder, MD | Chest, Infectious Diseases and Critical Care Assoc., PC |
Principal Investigator: | Ann Silverman, MD | Henry Ford Health System |
Principal Investigator: | John Pullman, MD | Mercury Street Medical Group |
Principal Investigator: | Rodney J Mason, MD | LAC/USC Medical Center |
Principal Investigator: | Doria Grimard, MD | Centre de Sante et de Services Sociaux de Chicoutimi |
Principal Investigator: | Darrell Pardi, MD | Mayo Clinic |
Responsible Party: | Massachusetts Biologic Laboratories ( Deborah Molrine ) |
Study ID Numbers: | CA-GCDX-06-02 |
Study First Received: | July 7, 2006 |
Last Updated: | April 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00350298 |
Health Authority: | United States: Food and Drug Administration |
Monoclonal antibody, Clostridium difficile Associated Diarrhea |
Antibodies, Monoclonal Bacterial Infections Antibodies Gram-Positive Bacterial Infections |
Diarrhea Clostridium Infections Immunoglobulins |
Immunologic Factors Physiological Effects of Drugs Infection Pharmacologic Actions |