Clinical trial • Phase II • Infectious Disease

Humanised IgG1 kappa (YTE) monoclonal antibody against Clostridioides difficile, toxin B for Recurrent Clostridioides difficile infection

Phase II trial of Humanised IgG1 kappa (YTE) monoclonal antibody against Clostridioides difficile, toxin B for Recurrent Clostridioides difficile infectio…

Overview

Trial Therapeutic Area
Infectious Disease
Trial Disease
Recurrent Clostridioides difficile infection
Trial Stage
Phase II
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
15-10-2025
First CTIS Authorization Date
16-02-2026

Trial design

Randomised, azd5148 (single dose im or iv; arm description lists "00" mg) vs placebo (normal saline)-controlled Phase II trial in Denmark, France, Germany and others.

Randomised
Yes
Comparator
AZD5148 (single dose IM or IV; arm description lists "00" mg) vs Placebo (normal saline)
Target Sample Size
137
Trial Duration For Participant
91

Eligibility

Recruits 137 Vulnerable population selected. Participants must be capable of giving signed informed consent ("capable of giving signed informed consent" is an explicit inclusion requirement). Subject information and informed consent forms are available (including materials referencing pregnancy and newborn data collection). No assent procedures for minors are described; all participants must be ≥18 and provide their own consent..

Vulnerable Population
Vulnerable population selected. Participants must be capable of giving signed informed consent ("capable of giving signed informed consent" is an explicit inclusion requirement). Subject information and informed consent forms are available (including materials referencing pregnancy and newborn data collection). No assent procedures for minors are described; all participants must be ≥18 and provide their own consent.

Inclusion criteria

  • {"criterion_text":"- Participant must be ≥ 18 years of age at the time of signing the informed consent, capable of giving signed informed consent."}
  • {"criterion_text":"- History of 3 or more unformed stools (Bristol stool scale 6 or 7) in ≤ 24 hours for 2 consecutive calendar days"}
  • {"criterion_text":"- Positive local C. difficile toxin test (eg, immune assay or CCNA) on an unformed stool sample collected during this episode"}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- Note: Diarrhea is not required to be present on the day of IMP administration."}
  • {"criterion_text":"- Body weight ≥ 40 kg"}

Exclusion criteria

  • {"criterion_text":"- History of inflammatory bowel disease (eg, ulcerative colitis, Crohn’s disease, microscopic colitis)."}
  • {"criterion_text":"- Participant with a non - CDI (C. difficile infection) condition such that the participant routinely passes loose stool (eg, patients with an ostomy)"}
  • {"criterion_text":"- Planned surgery for C. difficile infection within 24 hours of enrollment"}
  • {"criterion_text":"- Current toxic megacolon and/or small bowel ileus"}
  • {"criterion_text":"- 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)."}
  • {"criterion_text":"- 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)"}
  • {"criterion_text":"- Due to receive more than 25 days of antibacterial drug therapy for C. difficile infection for the qualifying C. difficile infection episode"}
  • {"criterion_text":"- 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"}
  • {"criterion_text":"- 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"}
  • {"criterion_text":"- 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)"}
  • {"criterion_text":"- Administration of any licensed vaccine within 14 days before, or planned administration within 14 days, after IMP administration"}
  • {"criterion_text":"- 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"}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- 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 endpoints

  • {"endpoint_text":"- First occurrence of recurrent C. difficile infection","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Sustained clinical cure (ie, achievement of initial clinical cure + no recurrent C. difficile infection)","definition_or_measurement_approach":"Achievement of initial clinical cure + no recurrent C. difficile infection (as stated in endpoint text)."}

Recruitment

Planned Sample Size
137
Recruitment Window Months
25
Consent Approach
Informed consent must be provided and signed by the participant (participants must be ≥18 and "capable of giving signed informed consent"). Subject information sheets and ICFs are available (adult, prescreening and country-specific ICFs); translations and country-specific ICF materials are present (full title translations include French, Greek, Hungarian, Spanish). Specific assent procedures for minors are not described.

Geography

Total Number Of Sites
50
Total Number Of Participants
122

Denmark

Earliest CTIS Part Ii Submission Date
10-02-2026
Latest Decision Or Authorization Date
16-02-2026
Processing Time Days
6
Number Of Sites
5
Number Of Participants
16

Sites

Site Name
Odense University Hospital
Department Name
Department of Infectious Diseases
Principal Investigator Name
Isik Johansen
Principal Investigator Email
isik.somuncu.johansen@rsyd.dk
Contact Person Name
Isik Johansen
Contact Person Email
isik.somuncu.johansen@rsyd.dk
Site Name
Rigshospitalet
Department Name
Department of Infectious Diseases
Principal Investigator Name
Inger Hee Mabuza Mathiesen
Principal Investigator Email
morten.helms@regionh.dk
Contact Person Name
Inger Hee Mabuza Mathiesen
Contact Person Email
morten.helms@regionh.dk
Site Name
Region Midtjylland
Department Name
Department of Hepatology and Gastroenterology
Principal Investigator Name
Christian Lodberg Hvas
Principal Investigator Email
chvas@clin.au.dk
Contact Person Name
Christian Lodberg Hvas
Contact Person Email
chvas@clin.au.dk
Site Name
Region Hovedstaden
Department Name
Department of Infectious Diseases
Principal Investigator Name
Morten Helms
Principal Investigator Email
morten.helms@regionh.dk
Contact Person Name
Morten Helms
Contact Person Email
morten.helms@regionh.dk
Site Name
Aalborg University Hospital
Department Name
Department of Medical Gastroenterology
Principal Investigator Name
Lars Vinter-Jensen
Principal Investigator Email
l.vinterjensen@rn.dk
Contact Person Name
Lars Vinter-Jensen
Contact Person Email
l.vinterjensen@rn.dk

France

Earliest CTIS Part Ii Submission Date
02-02-2026
Latest Decision Or Authorization Date
17-02-2026
Processing Time Days
15
Number Of Sites
7
Number Of Participants
13

Sites

Site Name
Centre Hospitalier Universitaire De Nimes
Department Name
Maladies infectieuses et tropicales
Principal Investigator Name
Paul Loubet
Principal Investigator Email
paul.loubet@chu-nimes.fr
Contact Person Name
Paul Loubet
Contact Person Email
paul.loubet@chu-nimes.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Maladies infectieuses et tropicales
Principal Investigator Name
Vincent Le Moing
Principal Investigator Email
v-le_moing@chu-montpellier.fr
Contact Person Name
Vincent Le Moing
Contact Person Email
v-le_moing@chu-montpellier.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Maladies infectieuses et tropicales
Principal Investigator Name
Adrien Lemaignan
Principal Investigator Email
adrien.lemaignen@univ-tours.fr
Contact Person Name
Adrien Lemaignan
Contact Person Email
adrien.lemaignen@univ-tours.fr
Site Name
Hospices Civils De Lyon
Department Name
Hepatologie et Gastroenterologie
Principal Investigator Name
Nicolas Benech
Principal Investigator Email
nicolas.benech@chu-lyon.fr
Contact Person Name
Nicolas Benech
Contact Person Email
nicolas.benech@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Maladies infectieuses et tropicales
Principal Investigator Name
David Bontoille
Principal Investigator Email
david.boutoille@chu-nantes.fr
Contact Person Name
David Bontoille
Contact Person Email
david.boutoille@chu-nantes.fr
Site Name
Hopital Cochin Saint Vincent De Paul
Department Name
Centre d'investigation clinique
Principal Investigator Name
Odile Launay
Principal Investigator Email
odile.launay@aphp.fr
Contact Person Name
Odile Launay
Contact Person Email
odile.launay@aphp.fr
Site Name
Hopital Saint Louis
Department Name
Maladies infectieuses et tropicales
Principal Investigator Name
Jean Michel Molina
Principal Investigator Email
jean-michel.molina@aphp.fr
Contact Person Name
Jean Michel Molina
Contact Person Email
jean-michel.molina@aphp.fr

Germany

Earliest CTIS Part Ii Submission Date
21-01-2026
Latest Decision Or Authorization Date
17-02-2026
Processing Time Days
27
Number Of Sites
8
Number Of Participants
20

Sites

Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Zentrum Innere Medizin Institut für Infektionsforschung und Impfstoffentwicklung
Principal Investigator Name
Stefan Schmiedel
Principal Investigator Email
s.schmiedel@uke.de
Contact Person Name
Stefan Schmiedel
Contact Person Email
s.schmiedel@uke.de
Site Name
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Department Name
Klinik und Poliklinik für Innere Medizin II
Principal Investigator Name
Christoph Spinner
Principal Investigator Email
christoph.spinner@mri.tum.de
Contact Person Name
Christoph Spinner
Contact Person Email
christoph.spinner@mri.tum.de
Site Name
Universitaetsklinikum Jena KöR
Department Name
Klinik für Innere Medizin IV
Principal Investigator Name
Philipp Reuken
Principal Investigator Email
philipp.reuken@med.uni-jena.de
Contact Person Name
Philipp Reuken
Contact Person Email
philipp.reuken@med.uni-jena.de
Site Name
Universitaetsklinikum Koeln AöR
Department Name
Klinik I für Innere Medizin
Principal Investigator Name
Lena Biehl
Principal Investigator Email
lena.biehl@uk-koeln.de
Contact Person Name
Lena Biehl
Contact Person Email
lena.biehl@uk-koeln.de
Site Name
Universitaetsklinikum Augsburg
Department Name
III. Medizinische Klinik
Principal Investigator Name
André Fuchs
Principal Investigator Email
andre.fuchs@uk-augsburg.de
Contact Person Name
André Fuchs
Contact Person Email
andre.fuchs@uk-augsburg.de
Site Name
Universitaetsklinikum Leipzig AöR
Department Name
Klinik und Poliklinik für Hämatologie, Zelltherapie, Hämostaseologie und Infektiologie
Principal Investigator Name
Christoph Lübbert
Principal Investigator Email
Christoph.Luebbert@medizin.uni-leipzig.de
Contact Person Name
Christoph Lübbert
Site Name
Goethe University Frankfurt
Department Name
ZIM II, Infektiologie
Principal Investigator Name
Maria Vehreschild
Principal Investigator Email
maria.vehreschild@unimedizin-ffm.de
Contact Person Name
Maria Vehreschild
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Klinik für Infektiologie und Intensivmedizin
Principal Investigator Name
Leif Erik Sander
Principal Investigator Email
leif-erik.sander@charite.de
Contact Person Name
Leif Erik Sander
Contact Person Email
leif-erik.sander@charite.de

Hungary

Earliest CTIS Part Ii Submission Date
16-01-2026
Latest Decision Or Authorization Date
20-02-2026
Processing Time Days
35
Number Of Sites
8
Number Of Participants
15

Sites

Site Name
University Of Pecs
Department Name
I. sz. Belgyógyászati Klinika, Infektológiai Osztály
Principal Investigator Name
Dávid Sipos
Principal Investigator Email
sipos.david@pte.hu
Contact Person Name
Dávid Sipos
Contact Person Email
sipos.david@pte.hu
Site Name
University Of Szeged
Department Name
Szent-Györgyi Albert Klinikai Központ Purjesz Béla Infektológiai Klinikai és Oktatási Központ
Principal Investigator Name
Edit Hajdú
Principal Investigator Email
horvathne.hajdu.edit@med.u-szeged.hu
Contact Person Name
Edit Hajdú
Site Name
University Of Debrecen
Department Name
Infektológiai Klinika
Principal Investigator Name
István Várkonyi
Principal Investigator Email
varkonyi.istvan@med.unideb.hu
Contact Person Name
István Várkonyi
Contact Person Email
varkonyi.istvan@med.unideb.hu
Site Name
Semmelweis University
Department Name
Sebészeti, Transzplantációs és Gasztroenterológiai Klinika
Principal Investigator Name
Diána Czompa
Principal Investigator Email
czompa.diana@semmelweis.hu
Contact Person Name
Diána Czompa
Contact Person Email
czompa.diana@semmelweis.hu
Site Name
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Department Name
Gasztroenterológiai Osztály
Principal Investigator Name
András Káfony
Principal Investigator Email
kutatas@tatabanyakorhaz.hu
Contact Person Name
András Káfony
Contact Person Email
kutatas@tatabanyakorhaz.hu
Site Name
University Of Debrecen (additional listed site)
Department Name
Infektológiai Klinika
Principal Investigator Name
István Várkonyi
Principal Investigator Email
varkonyi.istvan@med.unideb.hu
Contact Person Name
István Várkonyi
Contact Person Email
varkonyi.istvan@med.unideb.hu
Site Name
Heves Varmegyei Markhot Ferenc Oktatokorhaz Es Rendelointezet
Department Name
Belgyógyászati-Infektológiai Centrum Infektológiai Osztály
Principal Investigator Name
Éva Pongor
Principal Investigator Email
evapongor@gmail.com
Contact Person Name
Éva Pongor
Contact Person Email
evapongor@gmail.com
Site Name
Kistarcsai Flor Ferenc Korhaz
Department Name
V. Belgyógyászati Osztály
Principal Investigator Name
Róbert Kirschner
Principal Investigator Email
kirschner.robert.budapest@gmail.com
Contact Person Name
Róbert Kirschner

Italy

Earliest CTIS Part Ii Submission Date
21-01-2026
Latest Decision Or Authorization Date
23-02-2026
Processing Time Days
33
Number Of Sites
5
Number Of Participants
10

Sites

Site Name
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Department Name
Infectious and tropical Diseases Department
Principal Investigator Name
Antonio Cascio
Principal Investigator Email
antonio.cascio03@unipa.it
Contact Person Name
Antonio Cascio
Contact Person Email
antonio.cascio03@unipa.it
Site Name
Azienda Socio Sanitaria Territoriale Dei Sette Laghi
Department Name
General Medicine
Principal Investigator Name
Francesco Dentali
Principal Investigator Email
francesco.dentali@asst-settelaghi.it
Contact Person Name
Francesco Dentali
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
Infectious Diseases
Principal Investigator Name
Marco Falcone
Principal Investigator Email
marco.falcone@unipi.it
Contact Person Name
Marco Falcone
Contact Person Email
marco.falcone@unipi.it
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
Infectious Diseases
Principal Investigator Name
Cristina Mussini
Principal Investigator Email
cristina.mussini@unimore.it
Contact Person Name
Cristina Mussini
Contact Person Email
cristina.mussini@unimore.it
Site Name
Azienda Ospedaliera Universitaria Federico II Di Napoli
Department Name
Infectious Diseases
Principal Investigator Name
Ivan Gentile
Principal Investigator Email
ivan.gentile@unina.it
Contact Person Name
Ivan Gentile
Contact Person Email
ivan.gentile@unina.it

Greece

Earliest CTIS Part Ii Submission Date
30-10-2025
Latest Decision Or Authorization Date
06-04-2026
Processing Time Days
158
Number Of Sites
5
Number Of Participants
10

Sites

Site Name
Geniko Nosokomeio Thessalonikis George Papanikolaou
Department Name
Respiratory Department
Principal Investigator Name
Konstantinos Porpodis
Principal Investigator Email
kporpodis@yahoo.gr
Contact Person Name
Konstantinos Porpodis
Contact Person Email
kporpodis@yahoo.gr
Site Name
University General Hospital Of Ioannina
Department Name
1st Dpt of Internal Medicine
Principal Investigator Name
Charalampos Milionis
Principal Investigator Email
hmilioni@uoi.gr
Contact Person Name
Charalampos Milionis
Contact Person Email
hmilioni@uoi.gr
Site Name
University General Hospital Of Heraklion
Department Name
Internal Medicine Department
Principal Investigator Name
Diamantis Kofteridis
Principal Investigator Email
kofterid@med.uoc.gr
Contact Person Name
Diamantis Kofteridis
Contact Person Email
kofterid@med.uoc.gr
Site Name
Laiko General Hospital Of Athens
Department Name
A' Propaedeutic Internal Medicine Department
Principal Investigator Name
Fotinie Ntziora
Principal Investigator Email
fotinientziora@gmail.com
Contact Person Name
Fotinie Ntziora
Contact Person Email
fotinientziora@gmail.com
Site Name
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
Department Name
4th Internal Medicine Clinic
Principal Investigator Name
Sotirios Tsiodras
Principal Investigator Email
sotirios.tsiodras@gmail.com
Contact Person Name
Sotirios Tsiodras
Contact Person Email
sotirios.tsiodras@gmail.com

Spain

Earliest CTIS Part Ii Submission Date
15-12-2025
Latest Decision Or Authorization Date
17-04-2026
Processing Time Days
123
Number Of Sites
8
Number Of Participants
26

Sites

Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Servicio de Medicina Preventiva
Principal Investigator Name
Helena Moza Moriñigo
Principal Investigator Email
helena.moza@quironsalud.es
Contact Person Name
Helena Moza Moriñigo
Contact Person Email
helena.moza@quironsalud.es
Site Name
Hospital Universitario La Paz
Department Name
Servicio de Medicina Interna
Principal Investigator Name
Beatriz Diaz Pollan
Principal Investigator Email
vbdiazp@salud.madrid.org
Contact Person Name
Beatriz Diaz Pollan
Contact Person Email
vbdiazp@salud.madrid.org
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Microbiología Clínica y Enfermedades Infecciosas
Principal Investigator Name
Elena Reigadas Ramirez
Principal Investigator Email
helenrei@hotmail.com
Contact Person Name
Elena Reigadas Ramirez
Contact Person Email
helenrei@hotmail.com
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Servicio de Enfermedades Infecciosas
Principal Investigator Name
Francisco Javier Cobo Reinoso
Principal Investigator Email
Javier.cobo@salud.madrid.org
Contact Person Name
Francisco Javier Cobo Reinoso
Contact Person Email
Javier.cobo@salud.madrid.org
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
UGC Enfermedades Infecciosas
Principal Investigator Name
Sandra de la Rosa Riestra
Principal Investigator Email
sandrarosariestra@gmail.com
Contact Person Name
Sandra de la Rosa Riestra
Contact Person Email
sandrarosariestra@gmail.com
Site Name
Hospital General Universitario Dr. Balmis
Department Name
Unidad de Enfermedades Infecciosas
Principal Investigator Name
Esperanza Merino de Lucas
Principal Investigator Email
merino_luc@gva.es
Contact Person Name
Esperanza Merino de Lucas
Contact Person Email
merino_luc@gva.es
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Enfermedades Infecciosas Medicina Interna
Principal Investigator Name
Antonio Ramos Martinez
Principal Investigator Email
aramosm@salud.madrid.org
Contact Person Name
Antonio Ramos Martinez
Contact Person Email
aramosm@salud.madrid.org
Site Name
Hospital Germans Trias I Pujol
Department Name
Unitat Malalties Infeccioses
Principal Investigator Name
Jose Ramon Santos Fernandez
Principal Investigator Email
jrsantos@lluita.org
Contact Person Name
Jose Ramon Santos Fernandez
Contact Person Email
jrsantos@lluita.org

Sweden

Earliest CTIS Part Ii Submission Date
30-10-2025
Latest Decision Or Authorization Date
06-05-2026
Processing Time Days
188
Number Of Sites
4
Number Of Participants
12

Sites

Site Name
Region Vaestmanland
Department Name
Infektionsmottagningen, Sigtunagatan, Västmanlands sjukhus Västerås
Principal Investigator Name
Emeli Månsson
Principal Investigator Email
emeli.mansson@regionvastmanland.se
Contact Person Name
Emeli Månsson
Site Name
Region Skane Helsingborg Hospital
Department Name
Infektionsmottagning
Principal Investigator Name
Jonas Tverring
Principal Investigator Email
jonas.tverring@skane.se
Contact Person Name
Jonas Tverring
Contact Person Email
jonas.tverring@skane.se
Site Name
Region Skane Skanes Universitetssjukhus (Malmo)
Department Name
Infektionskliniken, Ruth Lundskogs gata 3
Principal Investigator Name
Maria Josephson
Principal Investigator Email
maria.eklundjosephson@skane.se
Contact Person Name
Maria Josephson
Contact Person Email
maria.eklundjosephson@skane.se
Site Name
Region Skane Skanes Universitetssjukhus (Lund)
Department Name
Infektionskliniken, Hälsogatan 3
Principal Investigator Name
Carl-Johan Fraenkel
Principal Investigator Email
carl-johan.fraenkel@skane.se
Contact Person Name
Carl-Johan Fraenkel
Contact Person Email
carl-johan.fraenkel@skane.se

Sponsor

Primary sponsor

Full Name
AstraZeneca AB
Organisation Type
Pharmaceutical company
Country Of Registered Address
Sweden

Investigational products

Investigational Product Name
AZD5148
Active Substance
Humanised IgG1 kappa (YTE) monoclonal antibody against Clostridioides difficile, toxin B
Modality
Monoclonal antibody
Routes Of Administration
Intramuscular (IM) or Intravenous (IV) push/infusion
Route
IM or IV
Starting Dose
00 mg
Frequency
Single dose
Investigational Product Name
Placebo for AZD5148
Modality
Other
Combination Treatment
Yes

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