A study to evaluate the effectiveness of AZD5148 in preventing the recurrence of Clostridioides difficile infection in adults.

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What is this study about?

This study investigates a way to prevent the return of Clostridioides difficile infection, a type of infection in the gut that often causes severe diarrhea. The research aims to determine if a new medication can reduce how often the infection comes back after the initial treatment. The medication being tested is called AZD5148, which is a monoclonal antibody. A monoclonal antibody is a type of protein made in a laboratory that is designed to find and attach to specific targets in the body, such as the toxin B produced by the bacteria.

Participants in the study will receive either AZD5148 or a placebo. The medication will be given as an intravenous infusion, which means it is delivered directly into a vein through a needle or tube. This treatment is administered alongside standard care, which includes regular antibacterial drugs used to treat the current infection. During the study, individuals will be monitored to see if the infection returns within a specific period of time.

Who Can Join the Study?

  • You must be at least 18 years old at the time you sign the consent form, which is the document where you agree to participate in the study.
  • You must be able to provide a signed informed consent, meaning you understand the study and agree to take part.
  • You must have had a recent episode of Clostridioides difficile infection (a type of bacterial infection in the gut).
  • You must have had 3 or more unformed stools (loose or watery bowel movements) within a 24-hour period for 2 days in a row.
  • Your stool sample must have tested positive for C. difficile toxin (a harmful substance produced by the bacteria) using a laboratory test.
  • You must be currently receiving standard of care antibacterial drug therapy, which refers to the usual medicines used to treat this infection, such as fidaxomicin, vancomycin, or metronidazole.
  • The treatment with these standard antibiotics must be planned to last between 10 and 25 days at the time you receive the study medicine.
  • Your body weight must be at least 40 kg.

Who Cannot Join the Study?

  • A history of inflammatory bowel disease, which refers to long-term swelling and irritation in the digestive tract, such as ulcerative colitis, Crohn’s disease, or microscopic colitis.
  • Having a condition other than C. difficile infection that causes regular loose stools, such as having an ostomy (a surgical opening that allows waste to leave the body).
  • Having a planned surgery for C. difficile infection within 24 hours of joining the study.
  • Having toxic megacolon, which is a severe complication where the colon becomes very swollen, or small bowel ileus, which is a condition where the muscles in the small intestine stop moving food through.
  • A history of a total colectomy (surgical removal of the entire large intestine) or bariatric surgery (weight loss surgery), unless the surgery was a restrictive type like banding that does not change the path of the digestive tract.
  • Having had major gastrointestinal surgery, such as removing a large part of the bowel, within 90 days before joining the study, though removing the appendix or gallbladder is allowed.
  • Being scheduled to receive more than 25 days of antibacterial drug therapy (medicine used to kill bacteria) for the current infection.
  • Having received a fecal donor transplant (transferring healthy stool from a donor) or fecal microbiota product within 180 days before, during, or within 180 days after receiving the study medicine.
  • Having received or planning to receive bezlotoxumab (a specific medicine for this infection) within 180 days before, during, or within 180 days after receiving the study medicine.
  • Taking specific medications like cholestyramine, nitazoxanide, rifaximin, tigecycline, or fusidic acid within 2 days before the study medicine, or being unable to avoid these medicines for 180 days after.
  • Receiving any licensed vaccine within 14 days before or 14 days after receiving the study medicine.
  • Receiving a high dose of human immunoglobulin (proteins used to help the immune system) within 4 weeks before or within 180 days after receiving the study medicine.
  • Planning to take medications that slow down gastrointestinal peristalsis (the natural wave-like muscle movements that move food through the gut), such as loperamide or diphenoxylate hydrochloride/atropine sulfate, within 14 days after receiving the study medicine.
  • Taking opioid medications (strong pain relievers) when the diarrhea first started, unless the person is on a stable dose or is expected to stop or reduce the dose.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Region Vaestmanland Vasteras Sweden
University Hospital Jena KöR Jena Germany
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy

Other Sites

Site Name City Country Status
Kistarcsai Flor Ferenc Korhaz Kistarcsa Hungary
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Centre Hospitalier Universitaire De Nimes Nimes France
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo Italy
Geniko Nosokomeio Thessalonikis George Papanikolaou Thessaloniki Greece
Komarom-Esztergom Varmegyei Szent Borbala Korhaz Tatabanya Hungary
Region Skane Helsingborg Hospital Helsingborg Sweden
University General Hospital Of Heraklion Heraklion Greece
Azienda Socio Sanitaria Territoriale Dei Sette Laghi Varese Italy
Region Skane Skanes Universitetssjukhus Lund Sweden
University Of Debrecen Debrecen Hungary
University General Hospital Of Ioannina Ioannina Greece
Odense University Hospital Odense Denmark
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Semmelweis University Budapest Hungary
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Centre Hospitalier Universitaire De Montpellier Montpellier France
Aalborg University Hospital Aalborg Denmark
Markhot Ferenc Oktatokorhaz Es Rendelointezet Eger Hungary
Centre Hospitalier Universitaire De Nantes Nantes France
Region Midtjylland Aarhus Denmark
Rigshospitalet Copenhagen Denmark
University Of Pecs Pecs Hungary
Centre Hospitalier Lyon Sud Pierre Benite France
University Of Szeged Szeged Hungary
Universitaetsklinikum Leipzig AöR Leipzig Germany
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Ucjbjoonmd Mfvqpzh Crvuid Hbotnwoitbfxrybfg Hamburg Germany
Ugmlenfwgzlgkmyszfopn Avjhtert Augsburg Germany
Lohsw Gpghqht Hhmavdis Or Ayecel Athens Greece
Ulqfszjawc Hnmxtcwn Cesvxmy Cologne Germany
Hdycdn Hoxmfryw Herlev Denmark
Ansdsauqzt Pcbpkaux Hemhxzaq Dp Pdjsi Paris France
Cidblk Hokdmvxkqsk Rtdctolm Uofemkzsuzjdi Dh Tddai Tours France
Gdyjcz Uqgstttecn Faqjlqzxt Frankfurt Germany
Fjbrxbbdj Pzxo Ls Iwtmtrpjysvdp Bwmxiqzlb Dsk Hlechwcs Uengxcyogdchl Lk Pso Madrid Spain
Hxzhfynp Ungfbbqknqhwm Heyfutsf Twyrq y Puvacg Ibobitjq Cdizbm dwvluzeewytfjlvtq (gveg Badalona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Denmark Denmark
Recruiting
19.12.2025
France France
Recruiting
19.12.2025
Germany Germany
Recruiting
19.12.2025
Greece Greece
Recruiting
19.12.2025
Hungary Hungary
Recruiting
19.12.2025
Italy Italy
Recruiting
19.12.2025
Spain Spain
Recruiting
19.12.2025
Sweden Sweden
Recruiting
19.12.2025

Trial locations

Investigated drugs:

AZD5148 is an experimental medicine given through a vein to help prevent the infection caused by a bacteria called Clostridioides difficile from coming back after a person has been treated with antibiotics.

Investigated diseases:

Recurrence of Clostridioides difficile infection – This condition occurs when an individual experiences a return of symptoms after an initial bout of infection caused by the bacterium Clostridioides difficile. The bacteria often produce toxins that damage the lining of the digestive tract. After a person starts to feel better, the bacteria or their toxins may persist in the gut. This can lead to the symptoms returning shortly after the initial infection has seemingly cleared. The cycle of infection and recovery can repeat if the bacteria are not fully managed.

Trial ID:
2025-521416-19-00
Protocol code:
D8820C00003 PRISM
Trial Phase:
Therapeutic exploratory (Phase II)

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