Authorised Therapeutic exploratory (Phase II) Recurrence of Clostridioides difficile Infection

Prevention of Recurrent C. difficile Infection Study with AZD5148 Monoclonal Antibody

EU CTIS ID: 2025-521416-19-00

What this study is testing

" To evaluate the efficacy of AZD5148 administered as a single dose - intramuscular (IM) or intravenous (IV) push, during standard of care (SoC) antibacterial drug therapy for C. difficile infection, to reduce recurrence of C. difficile infection compared to placebo through Day 91.

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

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 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, and - Positive local C. difficile toxin test (eg, immune assay or CCNA) on an unformed stool sample collected during this episode, and - Receipt of standard of care antibacterial drug therapy for C. difficile infection (fidaxomicin, vancomycin or metronidazole) for this episode, with planned duration of at least 10 and at most 25 days at time of IMP administration. Note: Diarrhea is not required to be present on the day of IMP administration. Body weight ≥ 40 kg

You likely can't join if

  • History of inflammatory bowel disease (eg, ulcerative colitis, Crohn’s disease, microscopic colitis). Participant 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 or bariatric surgery (bariatric surgery which does not disrupt the gastrointestinal lumen, ie, restrictive procedures such as banding, are permitted). 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 25 days of antibacterial drug therapy for C. difficile infection for the qualifying C. difficile infection episode Treatment with a fecal donor transplant or fecal microbiota product in the 180 days before IMP administration, are receiving or planned administration for the qualifying episode of C. difficile infection, 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 Oral cholestyramine, oral nitazoxanide, oral rifaximin; IV tigecycline, or oral or IV fusidic acid treatment in the 2 days before IMP administration, or due to receive more than a 24 - hour regimen of any of these medications in the 180 days after IMP administration (ie, cannot stop or avoid them) Administration of any licensed vaccine within 14 days before, or planned administration within 14 days, after IMP administration Receipt of human immunoglobulin to a total dose of > 0.7 g/kg (via any route) within the 4 - week period before IMP administration, or planned administration of a total dose > 0.7 mg/kg over any 4 - week period from IMP administration during the 180 days after IMP administration Medications given to decrease gastrointestinal peristalsis, such as loperamide (Imodium™) or diphenoxylate hydrochloride/atropine sulfate (Lomotil™) planned at any time during the 14 days after IMP administration. Participants receiving opioid medications at the onset of diarrhea. (They may be included if they are expected to be on stable doses of these medications or there is anticipation of a dose decrease or cessation of their use.)

The study team makes the final eligibility decision.

Where it's taking place

  • Canada
  • United States
  • United Kingdom
  • Japan
  • Australia

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, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Canada; United States; United Kingdom; Japan; Australia. 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 EU CTIS; the study team decides eligibility.