Study on VE303 for Preventing Recurrent C. difficile Infection in Patients

1 1

What is this study about?

This clinical trial is focused on studying a condition known as Clostridioides difficile infection, often referred to as CDI. This infection can cause severe diarrhea and other intestinal issues. The study is testing a new treatment called VE303, which is a capsule containing live bacteria that are believed to help restore balance in the gut. The trial will compare the effects of VE303 with a placebo, which looks like the VE303 capsule but does not contain any active bacteria.

The purpose of the study is to see if VE303 can prevent the recurrence of CDI. Participants in the study will be randomly assigned to receive either VE303 or the placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. The treatment will be taken orally, and the study will last for several weeks, with follow-up checks to monitor the participants’ health and any recurrence of the infection.

Throughout the study, participants will be asked to attend regular visits, provide samples, and complete questionnaires to help researchers gather data on the effectiveness of VE303. The main goal is to determine if VE303 can reduce the rate of CDI recurrence by the end of the study period. Participants’ health and any side effects will be closely monitored to ensure safety and gather comprehensive results.

1 Enrollment

Eligibility is determined based on age and medical history related to Clostridioides difficile infection (CDI).

Participants must have a laboratory-confirmed episode of CDI and meet specific criteria related to age and risk factors.

2 Completion of Standard Care Antibiotic Therapy

Participants complete a course of standard care (SoC) antibiotic therapy for CDI, lasting between 10 to 21 days.

The choice of antibiotic is determined by the physician, and tapering of antibiotics is not allowed.

3 Randomization and Start of Study Drug

Participants are randomly assigned to receive either the study drug VE303 or a placebo.

The first dose of the study drug is administered on the last planned day of SoC antibiotic therapy or no later than one day after completion.

4 Study Drug Administration

Participants take the study drug in the form of oral capsules.

The capsules are visually identical, ensuring that neither the participant nor the study team knows whether VE303 or placebo is being administered.

5 Monitoring and Follow-Up

Participants are monitored for recurrence of CDI and any adverse events for up to 24 weeks.

Regular assessments include providing blood and stool samples, completing questionnaires, and attending study visits.

6 End of Study

The primary endpoint is the proportion of participants with laboratory-confirmed CDI recurrence through Week 8.

Secondary endpoints include the incidence of adverse events and the relationship between VE303 colonization and CDI recurrence.

Who Can Join the Study?

  • For Stage 1: Must be at least 12 years old (or 18 years in some countries) and have had a confirmed episode of Clostridioides difficile infection (CDI), with at least one previous occurrence in the last 6 months.
  • For Stage 2: Must be at least 75 years old with a confirmed episode of CDI, or at least 12 years old (or 18 years in some countries) with a confirmed episode of CDI and at least two of the following risk factors:
    • Age 65 or older
    • Kidney problems, shown by a specific test result
    • Regular use of a type of medication called a proton pump inhibitor (PPI) in the past 2 months and expected to continue using it
    • Previous CDI episode between 6 and 12 months before joining the study
    • Weakened immune system due to a disease or its treatment
    • Had an organ or stem cell transplant
  • For both Stage 1 and Stage 2: The CDI episode must include:
    • At least 3 loose bowel movements in 24 hours for at least 2 days
    • Symptoms started within 4 weeks before starting antibiotic treatment for CDI
    • A stool sample tested positive for CDI before or shortly after starting antibiotics
    • Diarrhea not likely caused by something else
  • For both Stage 1 and Stage 2: Must complete a course of antibiotics for at least 10 days, up to 21 days, and show improvement with fewer than 3 loose bowel movements per day for at least 2 days.
  • For both Stage 1 and Stage 2: If able to have children, must have a negative pregnancy test and agree to use effective birth control, remain abstinent, or have a partner who cannot have children.
  • For both Stage 1 and Stage 2: Must be able to take the first dose of the study drug on the last day of antibiotic treatment or the day after.
  • For both Stage 1 and Stage 2: Must have recovered from any severe CDI complications and be stable.
  • For both Stage 1 and Stage 2: Must be able and willing to follow study procedures, such as taking capsules, attending visits, providing samples, and completing questionnaires.
  • For both Stage 1 and Stage 2: Must provide written consent to participate, understanding the risks and benefits. If under 18, a legal guardian must also provide consent.

Who Cannot Join the Study?

  • Individuals who do not have a Clostridioides difficile infection. This is a type of bacterial infection that affects the intestines.
  • Participants who are not within the specified age range for the study.
  • Individuals who are not able to follow the study procedures or instructions.
  • People who have other medical conditions that might interfere with the study or its results.
  • Participants who are taking medications that could affect the study outcomes.
  • Individuals who are pregnant or breastfeeding.
  • People who have participated in another clinical trial recently.
  • Individuals who have a history of substance abuse or other factors that might affect their ability to participate in the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy
Gyncentrum Sp. z o.o. Katowice Poland
Medicinski Centar Hipokrat-N EOOD Plovdiv Bulgaria
Hospitais da Universidade de Coimbra Coimbra Portugal
Niepubliczny Zakład Opieki Zdrowotnej Vivamed Jadwiga Miecz Warsaw Poland
Université Libre de Bruxelles – Hôpital Erasme Brussels Belgium

Other Sites

Site Name City Country Status
Unidade Local De Saude De Almada-Seixal E.P.E. Almada Portugal
ASST Fatebenefratelli Sacco Milan Italy
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Universitair Ziekenhuis Gent Gent Belgium
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Unidade Local De Saude De Gaia/Espinho E.P.E. Vila Nova De Gaia Portugal
Komarom-Esztergom Varmegyei Szent Borbala Korhaz Tatabanya Hungary
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Unidade Local De Saude Do Alto Ave E.P.E. Guimaraes Portugal
Our Lady Of Lourdes Hospital Drogheda Ireland
Multiprofile Hospital For Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOOD Gorna Oryahovitsa Bulgaria
Nemocnice Kyjov prispevkova organizace Kyjov Czechia
Spitalul Clinic De Boli Infectioase Si Tropicale Dr. Victor Babes Bucharest Romania
Centrul Medical Renasterea S.R.L. Craiova Romania
Azienda Unita’ Locale Socio Sanitaria N. 2 Marca Trevigiana Treviso Italy
Hospital Universitario Ramon Y Cajal Madrid Spain
Hospital General Universitario De Alicante Alicante Spain
Medical Center Excelsior OOD Sofia Bulgaria
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara Romania
Hospital Universitario Virgen Macarena Sevilla Spain
Hospital Universitario Reina Sofía Cordoba Spain
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Hospital Clinic De Barcelona Barcelona Spain
Fakultni Nemocnice Brno Brno Czechia
Semmelweis University Budapest Hungary
Universita’ Di Pisa Pisa Italy
Alessandro Manzoni Hospital Lecco Italy
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhaza Hungary
Hospital Universitario Virgen De Valme Sevilla Spain
MBAL Dr. Ivan Seliminski – Sliven AD Sliven Bulgaria
Centre Hospitalier Universitaire De Nantes Nantes France
Epimed Gesellschaft fuer epidemiologische und klinische Forschung in der Medizin mbH Berlin Germany
Fundacio Assistencial De Mutua De Terrassa Fpc Terrassa Spain
Region Midtjylland Aarhus Denmark
Ospedale Fatebenefratelli Isola Tiberina Gemelli Isola Rome Italy
Institutul National De Boli Infectioase Prof.Dr.Matei Bals Bucharest Romania
Unidade Local De Saude Da Guarda E.P.E. Guarda Portugal
Centro Hospitalar Universitario De Santo Antonio E.P.E. Porto Portugal
Multiprofile Hospital For Active Treatment Sveti Nikolay Chuditvorets EOOD Lom Bulgaria
Hopital Beaujon Clichy France
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
Ospedale Pediatrico Bambino Gesu’ Rome Italy
University Of Szeged Szeged Hungary
University Hospital Ostrava Ostrava Czechia
CHU Bordeauxt Bordeaux France
Spitalul Clinic De Boli Infectioase Sf. Parascheva Iasi Iasi Romania
Cjdeevgby Uzutikengnrvid Sxefikwou Woluwe-Saint-Lambert Belgium
Cfcmjk Hbxlqbadcwv Udhtxqixowgzc Rvdzi Reims France
Lakow Utgdioozfkdj Melmfcv Cljuxyq (itglh Leiden The Netherlands
Spgvupae Cdyisq Dn Bmxr Iiqgdsknies Cdrmmtppylx Cluj Napoca Romania
Bdjtvwwl Hbmudstr Dublin Ireland
Unfjfvmqnq Hgwmnupk Clghvom Cologne Germany
Cyanje Hqkoyvlpvst Uakbizfghbhta Dv Dkwit Dijon France
Cqugng Hpgogepequt Rxzkbfry Uanysqfgsgpwq De Tiuxp Tours France
Hjffqjdx Ubzisggfholkc Drrnwoiq Donostia / San Sebastian Spain
Aojrjuc Odpqshsrfvc Nlknlyfom So Ashehwv E Bqfzag E C Acfhyp Ahcxpourzfq Alexandria Italy
Gotogq Urxnreasfe Fzvpfkpux Frankfurt Germany
Hvsizaqd Da Lq Spkto Chza I Sjlt Phm Barcelona Spain
Goegnf Hjeqzomegjn Unchhqwzovxjk Pcysm Peztgmhltky En Negclvgwbvym Paris France
Ffaxaiyfc Pxfd Lu Ixxbbgqlmowed Bxdzrcdab Dnh Hbtuznqj Ururggerxeasu Lj Pbv Madrid Spain
Hhhyyozi Ungxesjessire Hlpekenb Tqugz y Prheng Itfdfeaj Cznbxr dxlgmmjrqxmvfncne (lhgj Badalona Spain
Ckr Crkwj Rxsjathjdbh Lyon France
Mezeyld Ctrfix Mgrhwffjza &rscpkd Bymsnu Burgas Bulgaria
Hdsdaaax Uyzejbcoakyfr du A Curypl A Coruna Galicia Spain

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
12.09.2024
Bulgaria Bulgaria
Recruiting
12.09.2024
Czechia Czechia
Not recruiting
12.09.2024
Denmark Denmark
Recruiting
12.09.2024
France France
Recruiting
12.09.2024
Germany Germany
Recruiting
12.09.2024
Hungary Hungary
Recruiting
12.09.2024
Ireland Ireland
Not recruiting
12.09.2024
Italy Italy
Recruiting
12.09.2024
Poland Poland
Not recruiting
12.09.2024
Portugal Portugal
Not recruiting
12.09.2024
Romania Romania
Recruiting
12.09.2024
Spain Spain
Recruiting
12.09.2024
The Netherlands The Netherlands
Recruiting
12.09.2024

Trial locations

VE303 is a medication being studied for its ability to prevent the recurrence of Clostridioides difficile infection (CDI). This medication is part of a clinical trial aimed at reducing the chances of CDI coming back in patients who have already experienced an infection. The trial is designed to see if VE303 can effectively lower the recurrence rate of CDI compared to not receiving the active treatment.

Investigated diseases:

Clostridioides difficile infection – This infection is caused by the bacterium Clostridioides difficile, which primarily affects the colon. It often occurs after the use of antibiotics, which can disrupt the normal balance of bacteria in the gut. Symptoms typically include diarrhea, abdominal pain, and fever. The infection can lead to inflammation of the colon, known as colitis. In some cases, it may cause severe complications like dehydration or bowel perforation. The disease can recur, especially if the initial infection is not fully resolved.

Trial ID:
2022-502972-22-00
Protocol code:
VE303-003
NCT ID:
NCT06237452
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

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

    Recruiting

    Investigated diseases:
    Investigated drugs:
    Denmark France Germany Greece Hungary Italy +2
  • Study on Optimizing Antibiotic Treatment for Clostridioides Difficile Infection with Vancomycin Hydrochloride in Adult Patients

    Recruiting

    1 1
    Investigated drugs:
    Czechia