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Prevention study for Clostridioides Difficile Infection
Official title Prevention of Recurrent C. Difficile Infection Study With AZD5148 Monoclonal Antibody
ClinicalTrials.gov ID: NCT07285213
What this study is testing
What is AZD5148?
AZD5148 is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for clostridioides difficile infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participant must be ≥ 18 years of age at the time of signing the informed consent, capable of giving signed informed consent. Participants with a...
- 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...
- 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...
- Planned initiation or receipt of antibacterial drug therapy for C. difficile infection (fidaxomicin, vancomycin or metronidazole) for this episode...
You likely can't join if
- Participants with a history of uncontrolled inflammatory bowel disease. Participants with a history of inflammatory bowel disease may be included if...
- 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...
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Chula Vista, California, United States
- Sacramento, California, United States
- Torrance, California, United States
- Hamden, Connecticut, United States
- Gainesville, Florida, United States
- Hialeah, Florida, United States
- Homestead, Florida, United States
- Jacksonville, Florida, United States
- Miami Lakes, Florida, United States
- Miramar, Florida, United States
- Port Orange, Florida, United States
- Tamarac, Florida, United States
- Tampa, Florida, United States
- Athens, Georgia, United States
- Atlanta, Georgia, United States
- Idaho Falls, Idaho, United States
- Burr Ridge, Illinois, United States
- Lexington, Kentucky, United States
- Louisville, Kentucky, United States
+ 90 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Chula Vista, California, United States; Sacramento, California, United States; Torrance, California, United States; Hamden, Connecticut, United States; Gainesville, Florida, United States and 104 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.