Actively Recruiting
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
Led by AstraZeneca · Updated on 2026-06-03
230
Participants Needed
114
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of AZD5148, a monoclonal antibody, for preventing the recurrence of Clostridioides difficile infection in adults aged 18 years and older. This Phase IIb, randomized, double-blind, placebo-controlled study aims to understand if a single dose of AZD5148 can reduce the chance of this infection returning, which is important for individuals who have recently had a C. difficile infection. Participants will be randomly assigned to receive one dose of either AZD5148 or a placebo, administered by intramuscular injection or intravenous push, based on the investigator's choice. Approximately 230 participants will be enrolled and stratified by geographic region. The study includes up to two visits for eligibility confirmation and dosing, followed by up to seven planned visits. Researchers will maintain contact through weekly and later monthly follow-ups and collect electronic diary entries from participants. During the study, participants will undergo stool sample collection and various assessments to monitor infection recurrence and safety. The primary outcome is the first occurrence of recurrent C. difficile infection within 91 days. Secondary outcomes include clinical cure, severity and duration of symptoms, adverse events, and immune response to AZD5148. Safety monitoring will continue for up to 361 days, ensuring comprehensive follow-up throughout the study period.
CONDITIONS
Brief Title
Prevention of Recurrent C. Difficile Infection Study With AZD5148 Monoclonal Antibody
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must be 18 years of age or older at the time of signing the informed consent and able to provide consent.
- Have a qualifying C. difficile infection episode confirmed by a positive local C. difficile toxin test on an unformed stool sample.
- Currently receiving standard antibacterial therapy for C. difficile infection (fidaxomicin, vancomycin, or metronidazole) with planned duration between 10 and 25 days at time of investigational product administration.
- Body weight of at least 40 kilograms.
- Diarrhea is not required on the day of investigational medicinal product administration.
You will not qualify if you...
- History of inflammatory bowel disease such as ulcerative colitis, Crohn's disease, or microscopic colitis.
- Conditions causing routine loose stool unrelated to C. difficile infection, such as patients with an ostomy.
- Planned surgery for C. difficile infection within 24 hours of enrollment.
- Current toxic megacolon or small bowel ileus.
- History of total colectomy or bariatric surgery that disrupts the gastrointestinal lumen.
- Major gastrointestinal surgery within 90 days before enrollment, excluding appendectomy or cholecystectomy.
- Planned antibacterial therapy exceeding 25 days for the qualifying infection episode.
- Treatment with fecal donor transplant or microbiota products within 180 days before or planned within 180 days after investigational product administration.
- Treatment with bezlotoxumab within 180 days before or planned within 180 days after investigational product administration.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Up to 2 site visits for confirmation of eligibility, including stool sample collection
Duration - Day 1
Participants receive a single dose of either AZD5148 or placebo administered by intramuscular injection or intravenous push.
1 visit (dose administration)
Duration - Up to 361 days
Participants are followed with weekly and later monthly contacts to monitor for recurrence of infection and safety, including electronic diary completion.
Up to 7 planned visits and regular contacts initiated by site staff
Trial Site Locations
Total: 114 locations
1
Research Site
Phoenix, Arizona, United States, 85032
Withdrawn
2
Research Site
Chula Vista, California, United States, 91911
Withdrawn
3
Research Site
Sacramento, California, United States, 95817
Not Yet Recruiting
4
Research Site
Torrance, California, United States, 90502
Actively Recruiting
5
Research Site
Hamden, Connecticut, United States, 06518
Actively Recruiting
6
Research Site
Gainesville, Florida, United States, 32605
Actively Recruiting
7
Research Site
Hialeah, Florida, United States, 33016
Not Yet Recruiting
8
Research Site
Homestead, Florida, United States, 33033
Actively Recruiting
9
Research Site
Jacksonville, Florida, United States, 32256
Actively Recruiting
10
Research Site
Miami Lakes, Florida, United States, 33014
Withdrawn
11
Research Site
Miramar, Florida, United States, 33027
Actively Recruiting
12
Research Site
Port Orange, Florida, United States, 32127
Withdrawn
13
Research Site
Tamarac, Florida, United States, 33321
Actively Recruiting
14
Research Site
Tampa, Florida, United States, 33607
Withdrawn
15
Research Site
Athens, Georgia, United States, 30606
Actively Recruiting
16
Research Site
Atlanta, Georgia, United States, 30322
Actively Recruiting
17
Research Site
Idaho Falls, Idaho, United States, 83404
Actively Recruiting
18
Research Site
Burr Ridge, Illinois, United States, 60527
Actively Recruiting
19
Research Site
Lexington, Kentucky, United States, 40509
Actively Recruiting
20
Research Site
Louisville, Kentucky, United States, 40202
Not Yet Recruiting
21
Research Site
New Orleans, Louisiana, United States, 70121
Actively Recruiting
22
Research Site
Glen Burnie, Maryland, United States, 21061
Actively Recruiting
23
Research Site
Potomac, Maryland, United States, 20854
Actively Recruiting
24
Research Site
Boston, Massachusetts, United States, 02114
Actively Recruiting
25
Research Site
Boston, Massachusetts, United States, 02115
Not Yet Recruiting
26
Research Site
Detroit, Michigan, United States, 48202
Actively Recruiting
27
Research Site
Royal Oak, Michigan, United States, 48073
Not Yet Recruiting
28
Research Site
Columbia, Missouri, United States, 65212
Not Yet Recruiting
29
Research Site
St Louis, Missouri, United States, 63130
Not Yet Recruiting
30
Research Site
Union City, New Jersey, United States, 07087
Not Yet Recruiting
31
Research Site
Hartsdale, New York, United States, 10530
Withdrawn
32
Research Site
Inwood, New York, United States, 11096
Withdrawn
33
Research Site
The Bronx, New York, United States, 10451
Actively Recruiting
34
Research Site
Salisbury, North Carolina, United States, 28144
Actively Recruiting
35
Research Site
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
36
Research Site
Pittsburgh, Pennsylvania, United States, 15237
Withdrawn
37
Research Site
Johnson City, Tennessee, United States, 37614
Actively Recruiting
38
Research Site
Charlottesville, Virginia, United States, 22903
Not Yet Recruiting
39
Research Site
Lynchburg, Virginia, United States, 24501
Actively Recruiting
40
Research Site
Roanoke, Virginia, United States, 24014
Actively Recruiting
41
Research Site
Seattle, Washington, United States, 98109
Not Yet Recruiting
42
Research Site
Madison, Wisconsin, United States, 53705
Not Yet Recruiting
43
Research Site
Camperdown, Australia, 2050
Actively Recruiting
44
Research Site
Clayton, Australia, 3168
Actively Recruiting
45
Research Site
Herston, Australia, 4029
Actively Recruiting
46
Research Site
Melbourne, Australia, 3000
Actively Recruiting
47
Research Site
South Brisbane, Australia, 4101
Actively Recruiting
48
Research Site
Edmonton, Alberta, Canada, T6G 2X8
Withdrawn
49
Research Site
Vancouver, British Columbia, Canada, V5Z 1M9
Actively Recruiting
50
Research Site
Victoria, British Columbia, Canada, V8T 5G4
Withdrawn
51
Research Site
Halifax, Nova Scotia, Canada, B3K 6R8
Not Yet Recruiting
52
Research Site
Hamilton, Ontario, Canada, L8N 4A6
Not Yet Recruiting
53
Research Site
London, Ontario, Canada, N6A 5A5
Actively Recruiting
54
Research Site
Montreal, Quebec, Canada, H4A 3S5
Actively Recruiting
55
Research Site
Québec, Quebec, Canada, G1V 4T3
Actively Recruiting
56
Research Site
Sherbrooke, Quebec, Canada, J1H 5N4
Not Yet Recruiting
57
Research Site
Aarhus N, Denmark, 8200
Actively Recruiting
58
Research Site
Gistrup, Denmark, 9260
Not Yet Recruiting
59
Research Site
Hvidovre, Denmark, 2650
Actively Recruiting
60
Research Site
København Ø, Denmark, 2100
Actively Recruiting
61
Research Site
Odense C, Denmark, 5000
Actively Recruiting
62
Research Site
Lyon, France, 69317
Actively Recruiting
63
Research Site
Montpellier, France, 34295
Not Yet Recruiting
64
Research Site
Nantes, France, 44093
Actively Recruiting
65
Research Site
Nîmes, France, 30029
Actively Recruiting
66
Research Site
Paris, France, 75014
Actively Recruiting
67
Research Site
Paris, France, 75475
Actively Recruiting
68
Research Site
Tours, France, 37044
Actively Recruiting
69
Research Site
Augsburg, Germany, 86156
Actively Recruiting
70
Research Site
Berlin, Germany, 13353
Actively Recruiting
71
Research Site
Cologne, Germany, 50937
Actively Recruiting
72
Research Site
Frankfurt, Germany, 60590
Actively Recruiting
73
Research Site
Hamburg, Germany, 20246
Actively Recruiting
74
Research Site
Jena, Germany, 07747
Withdrawn
75
Research Site
Leipzig, Germany, 04103
Actively Recruiting
76
Research Site
München, Germany, 81675
Actively Recruiting
77
Research Site
Athens, Greece, 11527
Actively Recruiting
78
Research Site
Athens, Greece, 12462
Actively Recruiting
79
Research Site
Heraklion, Greece, 71500
Actively Recruiting
80
Research Site
Ioannina, Greece, 45500
Actively Recruiting
81
Research Site
Thessaloniki, Greece, 57010
Actively Recruiting
82
Research Site
Budapest, Hungary, 1082
Actively Recruiting
83
Research Site
Debrecen, Hungary, 4031
Actively Recruiting
84
Research Site
Eger, Hungary, 3300
Actively Recruiting
85
Research Site
Kistarcsa, Hungary, 2143
Actively Recruiting
86
Research Site
Pécs, Hungary, 7624
Actively Recruiting
87
Research Site
Modena, Italy, 41124
Not Yet Recruiting
88
Research Site
Naples, Italy, 80131
Not Yet Recruiting
89
Research Site
Palermo, Italy, 90127
Actively Recruiting
90
Research Site
Pisa, Italy, 56124
Actively Recruiting
91
Research Site
Roma, Italy, 00161
Withdrawn
92
Research Site
Varese, Italy, 21100
Actively Recruiting
93
Research Site
Kochi, Japan, 780-8522
Actively Recruiting
94
Research Site
Kumamoto, Japan, 861-8520
Actively Recruiting
95
Research Site
Meguro-ku, Japan, 153-0051
Actively Recruiting
96
Research Site
Nagasaki, Japan, 852-8501
Actively Recruiting
97
Research Site
Shimonoseki-shi, Japan, 750-8520
Actively Recruiting
98
Research Site
Yaizu-shi, Japan, 425-8505
Actively Recruiting
99
Research Site
Lublin, Poland, 20-081
Withdrawn
100
Research Site
Warsaw, Poland, 04-141
Withdrawn
101
Research Site
Alicante, Spain, 03010
Actively Recruiting
102
Research Site
Badalona, Spain, 08916
Actively Recruiting
103
Research Site
Madrid, Spain, 28007
Actively Recruiting
104
Research Site
Madrid, Spain, 28034
Actively Recruiting
105
Research Site
Madrid, Spain, 28040
Actively Recruiting
106
Research Site
Madrid, Spain, 28046
Actively Recruiting
107
Research Site
Majadahonda, Spain, 28220
Actively Recruiting
108
Research Site
Seville, Spain, 41009
Actively Recruiting
109
Research Site
Helsingborg, Sweden, 25187
Withdrawn
110
Research Site
Lund, Sweden, 22185
Actively Recruiting
111
Research Site
Malmö, Sweden, 20502
Actively Recruiting
112
Research Site
Västerås, Sweden, 72189
Actively Recruiting
113
Research Site
Birmingham, United Kingdom, B15 2TH
Actively Recruiting
114
Research Site
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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