Back to resultsStudy of the Clinical Effectiveness of a Human Monoclonal Antibody to C. Difficile Toxin A and Toxin B in Patients With Clostridium Difficile Associated Disease
Primary Purpose
Clostridium Infections
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GS-CDA1/MDX-1388
normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Clostridium Infections focused on measuring Monoclonal antibody,, Clostridium difficile Associated Diarrhea
Eligibility Criteria
Inclusion Criteria: Patient > 18 years of age with diarrhea associated with a positive stool test for C. difficile toxin(s). Patients may be diagnosed with C. difficile by hospital/clinic/reference microbiology laboratory test or by a rapid diagnostic test performed by the study staff and positive test result must be within 14 days of enrollment. Patient must receive standard of care treatment for C. difficile associated disease. Standard of care treatment should include either metronidazole by mouth or intravenously or vancomycin by mouth. Patient or legal representative must have read, understood, and provided written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization after the nature of the study has been fully explained. Exclusion Criteria: History of chronic diarrheal illness such as ulcerative colitis or Crohn's disease. Score of 4 on modified Horn's index Severe C. difficile colitis with planned surgery in less than 24 hours. Positive pregnancy test within 24 hours of study infusion or an unwillingness to undergo pregnancy testing in females of child-bearing potential. Females capable of child-bearing must agree not to become pregnant from the time of study enrollment until at least 3 months after completion of study infusion. If a woman is sexually active and has no history of hysterectomy or tubal ligation, she must agree to use hormonal or barrier birth control with spermicidal gel. Breastfeeding. Receipt of other investigational study agent within previous 30 days. Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the patient participating in the study or make it unlikely the patient could complete the study.
Sites / Locations
- LAC/USC Medical Center
- UCLA CURE Digestive Diseases Center
- Kaiser Permanente Vaccine Study Center
- Christiana Care Health Systems
- Dr. Kiran C. Patel Research Institute
- Idaho Falls Infectious Diseases, PLLC
- Central Indiana Gastroenterology Group
- Chest, Infectious Diseases and Critical Care Assoc., PC
- University of Kentucky Medical Center
- Henry Ford Health System
- Mayo Clinic
- Saint Luke's Hospital of Kansas City
- Saint James Healthcare
- Jersey Shore University Medical Center
- Mount Sinai Hospital
- All-Trials Clinical Research, LLC
- Summa Health System
- Remington-Davis Clinical Research
- Rapid City Regional Hospital
- St. Lukes Episcopal Hospital
- Scott and White Memorial Hospital
- MultiCare Health System Research Services
- University of Calgary Foothills Medical Center
- Vancouver Island Health Research Centre
- Health Sciences Centre, University of Manitoba
- Kingston General Hospital
- Windsor Regional Hospital
- Centre de Sante et Services Sociaux de Chicoutimi
- Centre Hospitalier Regional de Trois-Rivieres
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
GS-CDA1/MDX-1388
Placebo
Arm Description
Biological: GS-CDA1/MDX-1388 One Intravenous dose
Biological: normal saline (0.9% sodium chloride) One Intravenous dose
Outcomes
Primary Outcome Measures
Number of Participants With Recurrence of Clostridium Difficile Associated Disease (CDAD)
Determine if the addition of C. difficile toxin A and toxin B human monoclonal anti-toxin antibodies to standard of care treatment reduces the number of subjects with recurrent CDAD compared to standard of care and placebo. Standard of care treatment is defined as receipt of either metronidazole by mouth or parenterally or receipt of vancomycin by mouth with a standard duration of treatment defined as 10 - 14 days (+ 2 days)). Recurrence of CDAD is defined as the development of a new episode of C. difficile disease associated with a positive C. difficile stool toxin(s) test after the resolution of prior episode and after discontinuation of SOC treatment.
Secondary Outcome Measures
Safety and Tolerability of Study Treatment by the Number of Adverse Events Reported
Safety and tolerability of a C. difficile toxin A human monoclonal antibody combined with a human monoclonal antibody to C. difficile toxin B in patients receiving standard of care treatment for C. difficile associated disease (CDAD) compared to those patients receiving standard of care and placebo reporting system organ class (SOC) MedDRA V.9.0
Time to Resolution of Initial CDAD Episode
Determine if the addition of a C. difficile toxin A human monoclonal antibody combined with C. difficile toxin B human monoclonal antibody to standard of care treatment reduces the time to resolution of diarrhea in patients with CDAD compared to those patients receiving standard of care and placebo. Resolution of CDAD is defined as the cessation of diarrhea for at least two consecutive days.
Number of Patients With Standard of Care Treatment Failure
Determine if the addition of a C. difficile toxin A human monoclonal antibody combined with C. difficile toxin B human monoclonal antibody to standard of care treatment reduces the number of patients who experience standard of care treatment failure compared to those patients receiving standard of care and placebo. Standard of care treatment failure is defined as (i) recurrence of diarrhea (after it had initially resolved) while on SOC treatment during the first 14 days, or (ii) change in SOC treatment (i.e., antibiotics given), or (iii) diarrhea episode lasting ≥14 days while on SOC treatment.
Number of Patients With Severe Initial C. Difficile Disease
Determine if the addition of a C. difficile toxin A human monoclonal antibody combined with C. difficile toxin B human monoclonal antibody to standard of care treatment reduces the number of patients with severe C. difficile disease compared to those patients receiving standard of care and placebo. Severe initial disease is defined as ≥ 5 unformed stools/day for 2 consecutive days from day 1 to the end of the initial episode of diarrhea and discontinuation of SOC.
Antibody Concentrations to Toxin A and to Toxin B Between Treatment Groups
Antibody concentrations to Toxin A and to Toxin B in those patients receiving C. difficile toxin A human monoclonal antibody combined with C. difficile toxin B human monoclonal antibody and standard of care treatment to those patients receiving standard of care and placebo
Full Information
NCT ID
NCT00350298
First Posted
July 7, 2006
Last Updated
January 21, 2021
Sponsor
MassBiologics
Collaborators
Medarex
1. Study Identification
Unique Protocol Identification Number
NCT00350298
Brief Title
Study of the Clinical Effectiveness of a Human Monoclonal Antibody to C. Difficile Toxin A and Toxin B in Patients With Clostridium Difficile Associated Disease
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
July 20, 2006 (Actual)
Primary Completion Date
June 25, 2008 (Actual)
Study Completion Date
June 25, 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MassBiologics
Collaborators
Medarex
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridium Infections
Keywords
Monoclonal antibody,, Clostridium difficile Associated Diarrhea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GS-CDA1/MDX-1388
Arm Type
Experimental
Arm Description
Biological: GS-CDA1/MDX-1388 One Intravenous dose
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Biological: normal saline (0.9% sodium chloride) One Intravenous dose
Intervention Type
Biological
Intervention Name(s)
GS-CDA1/MDX-1388
Intervention Description
One Intravenous dose
Intervention Type
Biological
Intervention Name(s)
normal saline
Intervention Description
One Intravenous dose
Primary Outcome Measure Information:
Title
Number of Participants With Recurrence of Clostridium Difficile Associated Disease (CDAD)
Description
Determine if the addition of C. difficile toxin A and toxin B human monoclonal anti-toxin antibodies to standard of care treatment reduces the number of subjects with recurrent CDAD compared to standard of care and placebo. Standard of care treatment is defined as receipt of either metronidazole by mouth or parenterally or receipt of vancomycin by mouth with a standard duration of treatment defined as 10 - 14 days (+ 2 days)). Recurrence of CDAD is defined as the development of a new episode of C. difficile disease associated with a positive C. difficile stool toxin(s) test after the resolution of prior episode and after discontinuation of SOC treatment.
Time Frame
Day 0 to Day 84
Secondary Outcome Measure Information:
Title
Safety and Tolerability of Study Treatment by the Number of Adverse Events Reported
Description
Safety and tolerability of a C. difficile toxin A human monoclonal antibody combined with a human monoclonal antibody to C. difficile toxin B in patients receiving standard of care treatment for C. difficile associated disease (CDAD) compared to those patients receiving standard of care and placebo reporting system organ class (SOC) MedDRA V.9.0
Time Frame
Day 0 to Day 84
Title
Time to Resolution of Initial CDAD Episode
Description
Determine if the addition of a C. difficile toxin A human monoclonal antibody combined with C. difficile toxin B human monoclonal antibody to standard of care treatment reduces the time to resolution of diarrhea in patients with CDAD compared to those patients receiving standard of care and placebo. Resolution of CDAD is defined as the cessation of diarrhea for at least two consecutive days.
Time Frame
Day 0 to Day 84
Title
Number of Patients With Standard of Care Treatment Failure
Description
Determine if the addition of a C. difficile toxin A human monoclonal antibody combined with C. difficile toxin B human monoclonal antibody to standard of care treatment reduces the number of patients who experience standard of care treatment failure compared to those patients receiving standard of care and placebo. Standard of care treatment failure is defined as (i) recurrence of diarrhea (after it had initially resolved) while on SOC treatment during the first 14 days, or (ii) change in SOC treatment (i.e., antibiotics given), or (iii) diarrhea episode lasting ≥14 days while on SOC treatment.
Time Frame
Day 0 to Day 84
Title
Number of Patients With Severe Initial C. Difficile Disease
Description
Determine if the addition of a C. difficile toxin A human monoclonal antibody combined with C. difficile toxin B human monoclonal antibody to standard of care treatment reduces the number of patients with severe C. difficile disease compared to those patients receiving standard of care and placebo. Severe initial disease is defined as ≥ 5 unformed stools/day for 2 consecutive days from day 1 to the end of the initial episode of diarrhea and discontinuation of SOC.
Time Frame
Day 0 to Day 84
Title
Antibody Concentrations to Toxin A and to Toxin B Between Treatment Groups
Description
Antibody concentrations to Toxin A and to Toxin B in those patients receiving C. difficile toxin A human monoclonal antibody combined with C. difficile toxin B human monoclonal antibody and standard of care treatment to those patients receiving standard of care and placebo
Time Frame
Day 0 to Day 84
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient > 18 years of age with diarrhea associated with a positive stool test for C. difficile toxin(s). Patients may be diagnosed with C. difficile by hospital/clinic/reference microbiology laboratory test or by a rapid diagnostic test performed by the study staff and positive test result must be within 14 days of enrollment.
Patient must receive standard of care treatment for C. difficile associated disease. Standard of care treatment should include either metronidazole by mouth or intravenously or vancomycin by mouth.
Patient or legal representative must have read, understood, and provided written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization after the nature of the study has been fully explained.
Exclusion Criteria:
History of chronic diarrheal illness such as ulcerative colitis or Crohn's disease.
Score of 4 on modified Horn's index
Severe C. difficile colitis with planned surgery in less than 24 hours.
Positive pregnancy test within 24 hours of study infusion or an unwillingness to undergo pregnancy testing in females of child-bearing potential. Females capable of child-bearing must agree not to become pregnant from the time of study enrollment until at least 3 months after completion of study infusion. If a woman is sexually active and has no history of hysterectomy or tubal ligation, she must agree to use hormonal or barrier birth control with spermicidal gel.
Breastfeeding.
Receipt of other investigational study agent within previous 30 days.
Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the patient participating in the study or make it unlikely the patient could complete the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger Baxter, MD
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Herbert DuPont, MD
Organizational Affiliation
St. Lukes Episcopal Hospital, Houston, TX
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joseph White, MD
Organizational Affiliation
Scott and White Memorial Hospital, Temple, TX
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Chen, MD
Organizational Affiliation
MultiCare Health System Research Services, Tacoma, WA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jorge Reyno, MD
Organizational Affiliation
Rapid City Regional Hospital, Rapid City, SD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Henry S. Sacks, MD, PhD
Organizational Affiliation
Mount Sinai Hospital, New York, NY
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Charles N. Bernstein, MD
Organizational Affiliation
University of Manitoba, Health Sciences Centre, Winnepeg, Manitoba, Canada
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael J. Tan, MD
Organizational Affiliation
Summa Health Systems, Akron, Ohio
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael C. Meadors, MD
Organizational Affiliation
All-Trials Clinical Research, LLC, Winston-Salem, NC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ian M. Baird, MD
Organizational Affiliation
Remington-Davis Clinical Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andre Poirier, MD, MSc
Organizational Affiliation
Centre Hospitalier Regional de Trois-Rivieres
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martha I. Buitrago, MD
Organizational Affiliation
Idaho Falls Infectious Diseases, PLLC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Kovacs, MD
Organizational Affiliation
UCLA CURE Digestive Diseases Research Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alfred Bacon, MD
Organizational Affiliation
Christiana Care Health Systems
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kathleen Casey, MD
Organizational Affiliation
Jersey Shore University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
C. Douglas Cochran, MD
Organizational Affiliation
Saint Luke's Hospital of Kansas City
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Donald Daly, MD
Organizational Affiliation
Vancouver Island Health Research Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anil Dhar, MBBS
Organizational Affiliation
Windsor Regional Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gerald Evans, MD
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard Greenberg, MD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Louie, MD
Organizational Affiliation
University of Calgary Foothills Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Nowak, MD
Organizational Affiliation
Central Indiana Gastroenterology Group
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jose Prieto, MD
Organizational Affiliation
Dr. Kiran C. Patel Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniel Schroeder, MD
Organizational Affiliation
Chest, Infectious Diseases and Critical Care Assoc., PC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ann Silverman, MD
Organizational Affiliation
Henry Ford Health System
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John Pullman, MD
Organizational Affiliation
Mercury Street Medical Group
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rodney J Mason, MD
Organizational Affiliation
LAC+USC Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Doria Grimard, MD
Organizational Affiliation
Centre de Sante et de Services Sociaux de Chicoutimi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Darrell Pardi, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
LAC/USC Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UCLA CURE Digestive Diseases Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Kaiser Permanente Vaccine Study Center
City
Oakland
State/Province
California
ZIP/Postal Code
94612
Country
United States
Facility Name
Christiana Care Health Systems
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
Dr. Kiran C. Patel Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Idaho Falls Infectious Diseases, PLLC
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Central Indiana Gastroenterology Group
City
Anderson
State/Province
Indiana
ZIP/Postal Code
46016
Country
United States
Facility Name
Chest, Infectious Diseases and Critical Care Assoc., PC
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Facility Name
University of Kentucky Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Henry Ford Health System
City
West Bloomfield
State/Province
Michigan
ZIP/Postal Code
48322
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Saint Luke's Hospital of Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Saint James Healthcare
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Jersey Shore University Medical Center
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07754
Country
United States
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
All-Trials Clinical Research, LLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Summa Health System
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
Facility Name
Remington-Davis Clinical Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Rapid City Regional Hospital
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
St. Lukes Episcopal Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Scott and White Memorial Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
MultiCare Health System Research Services
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
University of Calgary Foothills Medical Center
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
Vancouver Island Health Research Centre
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 1J8
Country
Canada
Facility Name
Health Sciences Centre, University of Manitoba
City
Winnepeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
Facility Name
Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
Windsor Regional Hospital
City
WIndsor
State/Province
Ontario
ZIP/Postal Code
N8W 1L9
Country
Canada
Facility Name
Centre de Sante et Services Sociaux de Chicoutimi
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 5H6
Country
Canada
Facility Name
Centre Hospitalier Regional de Trois-Rivieres
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G8Z 3R9
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
31411386
Citation
Montgomery DL, Matthews RP, Yee KL, Tobias LM, Dorr MB, Wrishko RE. Assessment of Bezlotoxumab Immunogenicity. Clin Pharmacol Drug Dev. 2020 Apr;9(3):330-340. doi: 10.1002/cpdd.729. Epub 2019 Aug 14.
Results Reference
derived
PubMed Identifier
27365387
Citation
Gupta SB, Mehta V, Dubberke ER, Zhao X, Dorr MB, Guris D, Molrine D, Leney M, Miller M, Dupin M, Mast TC. Antibodies to Toxin B Are Protective Against Clostridium difficile Infection Recurrence. Clin Infect Dis. 2016 Sep 15;63(6):730-734. doi: 10.1093/cid/ciw364. Epub 2016 Jun 30.
Results Reference
derived
PubMed Identifier
20089970
Citation
Lowy I, Molrine DC, Leav BA, Blair BM, Baxter R, Gerding DN, Nichol G, Thomas WD Jr, Leney M, Sloan S, Hay CA, Ambrosino DM. Treatment with monoclonal antibodies against Clostridium difficile toxins. N Engl J Med. 2010 Jan 21;362(3):197-205. doi: 10.1056/NEJMoa0907635.
Results Reference
derived
Learn more about this trial
Study of the Clinical Effectiveness of a Human Monoclonal Antibody to C. Difficile Toxin A and Toxin B in Patients With Clostridium Difficile Associated Disease
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