Trials Sponsors Conditions Drugs Pricing

Conditions

Clostridium Infections

Keywords

Monoclonal antibody,Clostridium difficile Associated Diarrhea

Outcome Measures

Primary Outcomes (1)

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.
Day 0 to Day 84

Secondary Outcomes (5)

Safety and Tolerability of Study Treatment by the Number of Adverse Events Reported
Day 0 to Day 84
Time to Resolution of Initial CDAD Episode
Day 0 to Day 84
Number of Patients With Standard of Care Treatment Failure
Day 0 to Day 84
Number of Patients With Severe Initial C. Difficile Disease
Day 0 to Day 84
Antibody Concentrations to Toxin A and to Toxin B Between Treatment Groups
Day 0 to Day 84

Study Arms (2)

GS-CDA1/MDX-1388

EXPERIMENTAL

Biological: GS-CDA1/MDX-1388 One Intravenous dose

Biological: GS-CDA1/MDX-1388

Placebo

PLACEBO COMPARATOR

Biological: normal saline (0.9% sodium chloride) One Intravenous dose

Biological: normal saline

Interventions

GS-CDA1/MDX-1388Biological

One Intravenous dose

GS-CDA1/MDX-1388

normal salineBiological

One Intravenous dose

Placebo

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

Sponsors & Collaborators

Medarex
Industrycollaborator
MassBiologics
Otherlead

Study Sites (29)

LAC/USC Medical Center

Los Angeles, California, 90033, United States

UCLA CURE Digestive Diseases Center

Los Angeles, California, 90095, United States

Kaiser Permanente Vaccine Study Center

Oakland, California, 94612, United States

Christiana Care Health Systems

Newark, Delaware, 19718, United States

Dr. Kiran C. Patel Research Institute

Tampa, Florida, 33613, United States

Idaho Falls Infectious Diseases, PLLC

Idaho Falls, Idaho, 83404, United States

Central Indiana Gastroenterology Group

Related Publications (3)

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.
PMID: 31411386DERIVED
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.
PMID: 27365387DERIVED

MeSH Terms

Conditions

Clostridium Infections

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Results Point of Contact

Title: Director of Clinical Affairs
Organization: MassBiologics

Study Officials

Roger Baxter, MD
Kaiser Permanente
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

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: LTE60
Restrictive Agreement: Yes

Enrollment

200 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 7, 2006

First Posted

July 10, 2006

Study Start

July 20, 2006

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

GS-CDA1/MDX-1388

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (29)

Related Publications (3)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

GS-CDA1/MDX-1388

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (29)

Related Publications (3)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations