Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07285213

Prevention of Recurrent C. Difficile Infection Study With AZD5148 Monoclonal Antibody

Led by AstraZeneca · Updated on 2026-05-05

230

Participants Needed

114

Research Sites

109 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Prevention of Recurrent C. Difficile Infection Study With AZD5148 Monoclonal Antibody

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participant must be 18 years of age or older and able to give signed informed consent.
  • Participants must have a qualifying C. difficile infection episode confirmed by a positive toxin test on an unformed stool sample.
  • Participants must be receiving standard care antibacterial therapy for C. difficile infection (fidaxomicin, vancomycin, or metronidazole) for at least 10 days and no more than 25 days at the time of study treatment.
  • Body weight must be at least 40 kg.
Not Eligible

You will not qualify if you...

  • History of inflammatory bowel disease (such as ulcerative colitis, Crohn's disease, or microscopic colitis).
  • Having a condition other than C. difficile infection that causes routine loose stools (for example, having an ostomy).
  • Planned surgery for C. difficile infection within 24 hours of enrollment.
  • Current toxic megacolon and/or small bowel ileus.
  • History of total colectomy or bariatric surgery that disrupts the gastrointestinal lumen.
  • Major gastrointestinal surgery (significant bowel resection or diversion) within 90 days before enrollment, excluding appendectomy or cholecystectomy.
  • Expected to receive more than 25 days of antibacterial therapy for the current C. difficile infection episode.
  • Treatment with fecal donor transplant or fecal microbiota product within 180 days before or planned during 180 days after study treatment.
  • Treatment with bezlotoxumab within 180 days before or planned during 180 days after study treatment.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

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Withdrawn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

Not Yet 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

Not Yet 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

Not Yet 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

Not Yet 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

Not Yet 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

Aalborg, Denmark, DK9000

Not Yet Recruiting

58

Research Site

Aarhus N, Denmark, 8200

Actively 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

Not Yet 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

Not Yet Recruiting

75

Research Site

Leipzig, Germany, 04103

Actively Recruiting

76

Research Site

München, Germany, 81675

Actively Recruiting

77

Research Site

Athens, Greece, 11527

Not Yet Recruiting

78

Research Site

Athens, Greece, 12462

Not Yet Recruiting

79

Research Site

Heraklion, Greece, 71500

Not Yet Recruiting

80

Research Site

Ioannina, Greece, 45500

Not Yet 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

Not Yet 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

Not Yet 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

Not Yet Recruiting

111

Research Site

Malmö, Sweden, 20502

Not Yet 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

Loading map...

Research Team

A

AstraZeneca Clinical Study Information Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here