Prevention of Recurrent C. Difficile Infection Study With AZD5148 Monoclonal Antibody
Condition(s) studied
Investigational drug(s) / intervention(s)
AZD5148: Participants will receive a single dose A of AZD5148 administered via either intramuscular injection or intravenous push.
Placebo: Participants will receive a single dose of placebo (0.9% (w/v) sodium chloride for injection) administered via either intramuscular injection or intravenous push.
Study summary
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.
Eligibility
Primary outcome measure(s)
- First occurrence of recurrence of C difficile infection — Day 1 through day 91
Recurrence of C difficile infection (rCDI) occurring after initial clinical cure (ICC) of the qualifying C difficile infection (CDI). CDI is defined as a history of diarrhea (\>=3 unformed stools, ie, type 6 or 7 stool on Bristol Stool Scale in \<=24 hours for 2 consecutive calendar days) accompanied by a positive stool test for C difficile toxin.
Trial sites (117)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Phoenix | Arizona | Withdrawn |
| Research Site | Chula Vista | California | Withdrawn |
| Research Site | Sacramento | California | Recruiting |
| Research Site | Torrance | California | Recruiting |
| Research Site | Hamden | Connecticut | Recruiting |
| Research Site | Gainesville | Florida | Withdrawn |
| Research Site | Hialeah | Florida | Recruiting |
| Research Site | Homestead | Florida | Recruiting |
| Research Site | Jacksonville | Florida | Recruiting |
| Research Site | Miami Lakes | Florida | Withdrawn |
| Research Site | Miramar | Florida | Withdrawn |
| Research Site | Port Orange | Florida | Withdrawn |
| Research Site | Tamarac | Florida | Withdrawn |
| Research Site | Tampa | Florida | Withdrawn |
| Research Site | Athens | Georgia | Recruiting |
| Research Site | Atlanta | Georgia | Recruiting |
| Research Site | Idaho Falls | Idaho | Recruiting |
| Research Site | Burr Ridge | Illinois | Recruiting |
| Research Site | Lexington | Kentucky | Recruiting |
| Research Site | Louisville | Kentucky | Recruiting |
| Research Site | New Orleans | Louisiana | Recruiting |
| Research Site | Glen Burnie | Maryland | Recruiting |
| Research Site | Potomac | Maryland | Recruiting |
| Research Site | Boston | Massachusetts | Recruiting |
| Research Site | Boston | Massachusetts | Recruiting |
| Research Site | Detroit | Michigan | Recruiting |
| Research Site | Royal Oak | Michigan | Recruiting |
| Research Site | Columbia | Missouri | Recruiting |
| Research Site | Kansas City | Missouri | Not Yet Recruiting |
| Research Site | St Louis | Missouri | Not Yet Recruiting |
| Research Site | Union City | New Jersey | Recruiting |
| Research Site | Hartsdale | New York | Withdrawn |
| Research Site | Inwood | New York | Withdrawn |
| Research Site | The Bronx | New York | Recruiting |
| Research Site | Salisbury | North Carolina | Recruiting |
| Research Site | Winston-Salem | North Carolina | Recruiting |
| Research Site | Pittsburgh | Pennsylvania | Withdrawn |
| Research Site | Johnson City | Tennessee | Recruiting |
| Research Site | Charlottesville | Virginia | Recruiting |
| Research Site | Lynchburg | Virginia | Recruiting |
+ 77 more sites — see the full list on the official registry below.
More AstraZeneca trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07285213 on ClinicalTrials.gov ↗ ← All trials in Italy