臨床研究等提出・公開システム

Japanese

Date of registration	Dec. 18, 2025
Last modified on	Dec. 18, 2025
Trial ID	jRCT2031250579

Scientific Title	A Phase IIb, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AZD5148 for Prevention of Recurrence of Clostridioides difficile Infection in Individuals 18 Years of Age and Above (PRISM)
Public Title	A Phase IIb Study of the Efficacy and Safety of AZD5148 to Prevent Recurrence of Clostridioides difficile Infection

Contact for Scientific Queries	Name	Ageishi Yuji
	Affiliation	Astrazeneka K.K
	Address	3-1, Ofuka-cho, Kita-ku, Osaka-shi, Osaka
	Telephone	+81-6-4802-3600
	E-mail	RD-clinical-information-Japan@astrazeneca.com
Contact for Public Queries	Name	Ageishi Yuji
	Affiliation	Astrazeneka K.K
	Address	3-1, Ofuka-cho, Kita-ku, Osaka-shi, Osaka
	Telephone	+81-6-4802-3600
	E-mail	RD-clinical-information-Japan@astrazeneca.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Jan. 16, 2026
Target sample size		10
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	prevention purpose
Key inclusion & exclusion criteria	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: - 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 investigational medicinal product (IMP) administration. Body weight >_ 40 kg
	Exclusion Criteria	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.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Clostridioides difficile infection
Intervention(s)		AZD5148, 400 mg, single dose, IM or IV push / Placebo (0.9% (w/v) sodium chloride)
Primary Outcome(s)		First occurrence of recurrence of C difficile infection [ Time Frame: Day 1 through day 91 ]

Primary Sponsor	Astrazeneca K.K

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Review Board of Human Rights and Ethics for Clinical Studies
Address	2-2-1, Kyobashi, Chuo-ku, Tokyo, Japan, Tokyo
Telephone	+81-3-5213-0028
Approval Status	Approval
Date of approval	Nov. 28, 2025

Plan to share IPD	Yes
Plan description	Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this dose not mean all request will be approved.

Plan to share IPD

Yes

Plan description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this dose not mean all request will be approved.

Secondary ID(s)	NCT07285213
Issuing Authority	ClinicalTrials.gov

Countries of Recruitment（Except Japan）	Australia/Canada/Denmark/France/Germany/Greece/Hungary /Italy/Spain/Sweden/UK/USA