Prevention of Recurrent C. Difficile Infection Study With AZD5148 Monoclonal Antibody
Purpose
The purpose of this study is to evaluate the efficacy and safety of AZD5148 for prevention of recurrence of Clostridioides difficile infection in Individuals 18 years of age and above.
Condition
- Clostridioides Difficile Infection
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
Participant must be ≥ 18 years of age at the time of signing the informed consent, capable of giving signed informed consent. Participants with a qualifying C. difficile infection episode at the time of providing informed consent defined by: - History of 3 or more unformed stools (Bristol stool scale 6 or 7) in ≤ 24 hours for 2 consecutive calendar days, (Note: Diarrhea is not required to be present on the day of IMP administration) and - Positive local C. difficile toxin test (eg, immune assay or CCNA) on a stool sample collected during this episode, as part of routine clinical care (Note: Toxin testing, where not part of routine clinical care, may be conducted as a pre- screening activity; if this occurs, participant consent is required), and - Planned initiation or receipt of antibacterial drug therapy for C. difficile infection (fidaxomicin, vancomycin or metronidazole) for this episode, Note: At the time of randomization and IMP administration, the participant must have started receiving the antibacterial drug therapy with a planned total treatment duration of at least 10 and at most 28 days at time of IMP administration. IMP can be administered at any point during the antibacterial drug therapy. Body weight ≥ 35 kg
Exclusion Criteria
Participants with a history of uncontrolled inflammatory bowel disease. Participants with a history of inflammatory bowel disease may be included if, in the opinion of the Investigator, their disease is clinically controlled and presenting symptoms are more likely attributable to CDI than to a flare of inflammatory bowel disease. Participants with a non - CDI (C. difficile infection) condition such that the participant routinely passes loose stool (eg, patients with an ostomy) Planned surgery for C. difficile infection within 24 hours of enrollment Current toxic megacolon and/or small bowel ileus Any history of total colectomy Major gastrointestinal surgery as assessed by the Investigator (eg, significant bowel resection or diversion) within 90 days before enrollment (this does not include appendectomy or cholecystectomy) Due to receive more than 28 days of antibacterial drug therapy for the qualifying C. difficile infection episode Participants receiving a fecal microbiota transplant, fecal microbiota product, or live biotherapeutic product for the qualifying CDI episode, or planned administration during the 180 days after IMP administration. Treatment with bezlotoxumab in the 180 days before IMP administration, are receiving or planned administration for the qualifying episode of CDI, or planned administration during the 180 days after IMP administration.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- Double-blind: Participant, Care Provider, Investigator, Outcomes Assessor
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental AZD5148: dose A |
Participants will receive a single dose A of AZD5148 administered via either intramuscular injection or intravenous push. |
|
|
Placebo Comparator Placebo |
Participants will receive a single dose of placebo via intramuscular or intravenous push. |
|
Recruiting Locations
Torrance, California 90502
Hamden, Connecticut 06518
Gainesville, Florida 32605
Homestead, Florida 33033
Jacksonville, Florida 32256
Miramar, Florida 33027
Tamarac, Florida 33321
Athens, Georgia 30606
Atlanta, Georgia 30322
Idaho Falls, Idaho 83404
Burr Ridge, Illinois 60527
Lexington, Kentucky 40509
New Orleans, Louisiana 70121
Glen Burnie, Maryland 21061
Potomac, Maryland 20854
Boston, Massachusetts 02114
Detroit, Michigan 48202
Columbia, Missouri 65212
The Bronx, New York 10451
Salisbury, North Carolina 28144
Winston-Salem, North Carolina 27103
Johnson City, Tennessee 37614
Lynchburg, Virginia 24501
Roanoke, Virginia 24014
More Details
- Status
- Recruiting
- Sponsor
- AstraZeneca
Study Contact
AstraZeneca Clinical Study Information Center1-877-240-9479
information.center@astrazeneca.com
Detailed Description
Approximately 230 participants will be enrolled and randomized 1:1 to receive a single dose of either AZD5148 or placebo (normal saline). Route of administration (intramuscular or intravenous push) will be according to the Investigator's choice. Stratification will be based on geographical region. Study details include: - Up to 2 site visits for confirmation of eligibility and dose administration, including stool sample collection; - Up to 7 planned visits; - Contacts initiated by site staff -weekly, later monthly follow up; - Electronic diary completion.