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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AstraZeneca AB

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

Trial duration

12 Mar 2026 → ongoing

Decision date (initial)

2026-02-16

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

AstraZeneca AB

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis, Pharmacodynamic, Safety, Pharmacokinetic

"
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.

Secondary objectives 1

1. To evaluate the efficacy of AZD5148 administered as a single dose (IM or IV push), during standard of care (SoC) antibacterial drug therapy for C. difficile infection, in achieving sustained clinical cure compared to placebo through Day 91.

Conditions and MedDRA coding

Recurrence of Clostridioides difficile Infection

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 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

Exclusion criteria 1

1. 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.)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. First occurrence of recurrent C. difficile infection

Secondary endpoints 1

1. Sustained clinical cure (ie, achievement of initial clinical cure + no recurrent C. difficile infection)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AstraZeneca AB

Sponsor organisation

AstraZeneca AB

Address

-

City

Sodertalje

Postcode

151 85

Country

Sweden

Scientific contact point

Organisation

AstraZeneca AB

Contact name

AstraZeneca Clinical Study Information Center

Public contact point

Organisation

AstraZeneca AB

Contact name

AstraZeneca Clinical Study Information Center

Locations

8 EU/EEA countries · 49 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 44 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications