Clinical trial • Phase III • Infectious Disease

CLOSTRIDIA, CLUSTER XIVA, STRAIN RELATIVE CLOSTRIDIUM_Q SYMBIOSUM, LIVE; CLOSTRIDIA, CLUSTER XIVA, STRAIN RELATIVE ENTEROCLOSTER BOLTEAE, LIVE; CLOSTRIDIA, CLUSTER XIVA, STRAIN RELATIVE SELLIMONAS INTESTINALIS, LIVE; CLOSTRIDIA, CLUSTER IV, STRAIN RELATIVE FLAVONIFRACTOR PLAUTII, LIVE; CLOSTRIDIA, CLUSTER XIVA, STRAIN RELATIVE BLAUTIA SP001304935, LIVE; BACILLI, CLUSTER XVII, STRAIN RELATIVE CLOSTRIDIUM_AQ INNOCUUM, LIVE; CLOSTRIDIA, CLUSTER XIVA, STRAIN RELATIVE DOREA_A LONGICATENA, LIVE; CLOSTRIDIA, CLUSTER IV, STRAIN RELATIVE ANAEROTRUNCUS COLIHOMINIS, LIVE for Clostridioides difficile infection

Phase III trial of CLOSTRIDIA, CLUSTER XIVA, STRAIN RELATIVE CLOSTRIDIUM_Q SYMBIOSUM, LIVE; CLOSTRIDIA, CLUSTER XIVA, STRAIN RELATIVE ENTEROCLOSTER BOLTEA…

Overview

Trial Therapeutic Area
Infectious Disease
Trial Disease
Clostridioides difficile infection
Trial Stage
Phase III
Drug Modality
Other
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
14-06-2024
First CTIS Authorization Date
07-10-2024

Trial design

Randomised, open-label, placebo capsules containing microcrystalline cellulose, visually identical to and not discernible from ve303 capsules; administered orally, daily for 14 consecutive days (placebo arm).-controlled Phase III trial in Poland, Portugal, Czechia and others.

Randomised
Yes
Open Label
Yes
Comparator
Placebo capsules containing microcrystalline cellulose, visually identical to and not discernible from VE303 capsules; administered orally, daily for 14 consecutive days (placebo arm).
Target Sample Size
264
Trial Duration For Participant
168

Stratification factors

  • Standard-of-care antibiotic for qualifying CDI episode (vancomycin vs fidaxomicin vs other)
  • Age (< 18 years vs 18 to 64 years vs ≥ 65 years)
  • Number of previous CDI episodes at baseline in Stage 1 (2 vs ≥ 3)

Eligibility

Recruits 264 paediatric patients.

Pregnancy Exclusion
Pregnant or breastfeeding
Vulnerable Population
Minors/adolescents are included where permitted (enrollment allowed from age ≥12 in some countries). Informed consent must be written; when appropriate a legally-authorised representative (LAR) may provide consent. For participants younger than the age of majority (18 years in most geographies) consent must be signed or co-signed by the participant's legal guardian and a child-specific assent form may be used; country-specific assent/consent procedures and caregiver ICF forms are provided.

Inclusion criteria

  • {"criterion_text":"- For enrollment in Stage 1 (rCDI population): Age ≥ 12 years where enrollment of adolescents is permitted, and age ≥ 18 years of age or older in other countries, with a laboratory-confirmed qualifying episode of CDI and at least one prior occurrence of CDI within the last 6 months\n- Inclusion Criteria for the VE303 Safety Cohort: Inclusion criteria will be identical to the aforementioned Stage 1 population.\n- For enrollment in Stage 2 (pCDI-hr population): Age ≥ 75 years with a laboratory-confirmed qualifying episode of CDI or Age ≥ 12 years to 74 years where enrollment of adolescents is permitted, and age 18 to 74 in other countries, with a laboratory-confirmed qualifying episode of CDI and at least two of the following risk factors: Age ≥ 65 years Kidney dysfunction, defined as estimated creatinine clearance< 60mL/min/1.73 m2at the time of the qualifying CDI episode History of regular use of a proton pump inhibitor (PPI) within the past 2 months and expectation of continued use of PPIs throughout the study History of a prior CDI episode between 6 and 12 months prior to enrollment Immunosuppression due to an underlying disease or its treatment Has undergone solid organ or hematopoietic stem cell transplantation\n- For enrollment in either Stage 1 or Stage 2: The qualifying episode of CDI must meet all the following criteria: a. New onset of ≥ 3 unformed bowel movements (ie, Types 5 to 7 on the Bristol stool scale) within 24 hours for at least 2 consecutive days b. CDI symptoms started within 4 weeks prior to the initiation of SoC antibiotic therapy for CDI c. Stool sample collected before (or no later than 72 hours after) initiation of SoC antibiotic therapy that was positive in a CDI laboratory test, defined as EIA for toxin A/B and GDH, (with PCR reflex testing for discordant GDH/EIA results), as performed at either a local laboratory or the central laboratory d. Diarrhea considered unlikely to have another etiology\n- For enrollment in either Stage 1 or Stage 2: Prior to receiving study medication, the participant should: a.\tReceive and complete a course of SoC antibiotic therapy for at least 10 days, up to a maximum of 28 days (The choice of SoC agent is at the physician’s discretion. To ensure that adequate antibiotic levels are maintained in the gut to allow for subsequent VE303 strain colonization: i.\tVancomycin must be administered at a dosing frequency of at least twice daily. ii.\tFidaxomicin must be administered at a dosing frequency of at least once daily. b.Meet the criterion for a successful clinical response, defined as symptomatic control of the qualifying CDI episode, ie, < 3 loose/unformed bowel movements per 24 hours for at least 2 consecutive days.\n- For enrollment in either Stage 1 or Stage 2: Persons of childbearing potential must have a negative pregnancy test and must agree to either use a highly effective, acceptable form of birth control (highly effective contraception is defined as a method that can achieve a failure rate of less than 1% per year when used consistently and correctly, eg, established hormonal birth control plus a barrier method, hormonal methods of contraception when associated with inhibition of ovulation, including implants, injectables, combined oral contraceptives, some intrauterine devices), remain sexually abstinent during the study period and up to 3 months after the last dose of study drug, or be exclusively with female and/or vasectomized partner(s) who have had medical confirmation of surgical success. Sexual abstinence is defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject. Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhoea method are not acceptable methods of contraception.\n- For enrollment in either Stage 1 or Stage 2: Able to receive the first dose of study drug on the last planned day of SoC antibiotic administration for a qualifying CDI episode, or no later than 2 days after completion of antibiotic dosing\n- For enrollment in either Stage 1 or Stage 2: Recovered from any complications of severe or fulminant CDI and be clinically stable by the time of randomization\n- For enrollment in either Stage 1 or Stage 2: Able and willing to follow study assessments (eg, able to swallow oral capsules, comply with study visits and procedures, provide blood and stool samples, complete questionnaires)\n- For enrollment in either Stage 1 or Stage 2: Able and willing to provide written informed consent/assent prior to initiation of any study-specific procedure or study drug administration and aware of the potential risks and benefits of study enrollment and study drug administration. When appropriate, informed consent may be provided by a legally-authorized representative (LAR). For participants younger than the age of majority (18 years of age in most geographies), the consent should be signed or co-signed by the participant’s legal guardian and a child-specific assent form may be used, consistent with local regulations and practices."}

Exclusion criteria

  • {"criterion_text":"- for Double-Blind Treatment (1-18) :History of chronic diarrhea (defined as ≥ 3 loose stools per day lasting for at least 4 weeks) within 3 months prior to randomization that is not related to CDI\n- White blood cell count > 15.0 × 109 cells/L within 7 days prior to randomization\n- Pregnant or breastfeeding\n- Known hypersensitivity/allergy/intolerance to any ingredient in the VE303 study formulation.\n- Infectious diarrhea other than CDI (including bacterial, viral, or parasitic etiology) identified with the qualifying CDI episode\n- Clinically significant or poorly controlled medical or surgical condition not mentioned in the above criteria that, in the Investigator’s opinion, could interfere with the administration of study drug, interpretation of study’s safety or efficacy data, or compromise the safety or well-being of the participant.\n- Known or suspected toxic megacolon or small bowel ileus at the time of randomization\n- History of confirmed celiac disease, inflammatory bowel disease, microscopic colitis, short gut, gastrointestinal (GI) tract fistulas, or a recent episode (within 6 months of screening) of intestinal ischemia or ischemic colitis\n- Contraindication to oral/enteral therapy (eg, severe reflux, severe nausea/vomiting, or ileus) at the time of randomization\n- Absolute neutrophil count (ANC) of < 0.5 ×10^9 cells/L on 2 consecutive occasions within 7 days prior to randomization, or sustained ANC < 1.0 × 109 cells/L\n- Exclusion Criteria for the VE303 Safety Cohort: \tParticipants must be excluded from the study except where noted if any of the criteria are met. Exclusion criteria will be identical to the aforementioned Stage 1 population for points 1,2,3,5,7,9,10,11,12,13,14,15,16,17,18 excluding criterion: 6 and 8 as NA , and different for criterion: \t 4. GI tract fistulas .\n- Receipt of bezlotoxumab during the course of SoC antibiotic treatment for the qualifying CDI episode\n- Use of antidiarrheal drugs (eg, loperamide, diphenoxylate) within 3 days prior to the planned first dose of study drug\n- Anticipated administration of oral or parenteral antibacterial therapy for a non-CDI indication after randomization through week 24 (end of study).\n- Receipt of chemotherapy or other antineoplastic treatment with known GI adverse effects within 2 months prior to randomization\n- Receipt of any investigational drug or investigational vaccine within 30 days prior to randomization\n- Current or immediate potential for mechanical ventilation or vasopressors for hemodynamic support\n- Life expectancy of < 3 months\n- Major GI surgery (eg, significant bowel resection or diversion) within 3 months prior to randomization, current ileostomy, or history of total colectomy. Participants with a history of appendectomy, cholecystectomy, or gastric restrictive procedures, such as banding, may be permitted upon discussion with the Medical Monitor if surgery was at least 1 month prior to randomization and the participant has fully recovered"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Proportion of participants with central laboratory confirmed CDI recurrence through Week 8","definition_or_measurement_approach":"Central laboratory confirmed CDI recurrence assessed through Week 8 (proportion of participants with central laboratory confirmation of recurrence by Week 8)."}

Secondary endpoints

  • {"endpoint_text":"- Incidence and severity of treatment-emergent adverse events (TEAEs), treatment-related TEAEs, serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) through week 8 and 248 (primary safety endpoint) and week 24","definition_or_measurement_approach":"Safety endpoints: incidence and severity of TEAEs, treatment-related TEAEs, SAEs, MAAEs and AESIs assessed through Week 8 and Week 24 (with primary safety assessment at Week 8 and additional safety follow-up to Week 24)."}
  • {"endpoint_text":"- Proportion of participants with central laboratory confirmed CDI recurrence through Week 12 and Week 24","definition_or_measurement_approach":"Central laboratory confirmed CDI recurrence assessed through Weeks 12 and 24 (proportion of participants with recurrence by those timepoints)."}
  • {"endpoint_text":"- Fecal VE303 bacterial strain colonization detection, abundance and duration","definition_or_measurement_approach":"Detection, relative abundance and duration of VE303 bacterial strains in fecal samples (microbiological detection and abundance measures over time)."}
  • {"endpoint_text":"- Change from baseline in the the short-chain fatty acids (Cdiff32) score Change from baseline in EQ-5D score, utility index, and EuroQol Visual Analogue Scale ( EQ VAS ) score Change from baseline in CDI-Daily Symptoms ( CDI-DaySyms) daily symptoms score","definition_or_measurement_approach":"Patient-reported and biomarker endpoints: change from baseline in Cdiff32 (short-chain fatty acids) score, EQ-5D and EQ VAS scores, and CDI-Daily Symptoms (CDI-DaySyms) daily symptom scores measured at scheduled visits."}
  • {"endpoint_text":"- Relationship between of VE303 strain colonization and CDI recurrence rate and time to recurrence.","definition_or_measurement_approach":"Analysis of association between fecal colonization by VE303 strains and clinical outcomes (CDI recurrence rate and time to recurrence) using colonization detection/abundance measures and clinical recurrence data."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
264
Recruitment Window Months
36
Consent Approach
Written informed consent is required prior to any study procedures. When appropriate, a legally-authorised representative (LAR) may provide consent. For participants under the age of majority (generally <18 years), consent must be signed or co-signed by the participant’s legal guardian and a child-specific assent form may be used. Country-specific ICFs, caregiver ICFs and assent forms are provided; materials are available in multiple languages (English, Polish, Portuguese, Spanish, French, Dutch, Czech, German, Hungarian, Italian, Danish, Romanian, Bulgarian) as per country.

Methods

  • Recruitment posters displayed at sites (country-specific posters listed: e.g., Polish, Portuguese, Spanish, French, Dutch, Hungarian, Italian, Danish, Bulgarian materials).
  • Recruitment brochures and flyers distributed to patients and clinicians (country-specific brochures).
  • Recruitment procedure descriptions and physician referral cards provided to referring clinicians to facilitate referral.
  • Consent Navigator and Recruitment Website materials to support informed decision-making and remote recruitment/navigation.
  • Flipcharts and other outreach materials for site-based engagement and education of potential participants.

Geography

Total Number Of Sites
82
Total Number Of Participants
156

Poland

Earliest CTIS Part Ii Submission Date
27-09-2024
Latest Decision Or Authorization Date
13-10-2024
Processing Time Days
16
Number Of Sites
2
Number Of Participants
7

Sites

Site Name
Gyncentrum Sp. z o.o.
Department Name
2702: NZOZ Holsamed - Oddział Libero
Principal Investigator Name
Marek Olakowski
Principal Investigator Email
m.olakowski@holsaclinical.com
Contact Person Name
Marek Olakowski
Contact Person Email
m.olakowski@holsaclinical.com
Site Name
NZOZ Vivamed Jadwiga Miecz
Department Name
2703: Gastroenterology
Principal Investigator Name
Robert Petryka
Principal Investigator Email
robert@petrykamed.com
Contact Person Name
Robert Petryka
Contact Person Email
robert@petrykamed.com

Portugal

Earliest CTIS Part Ii Submission Date
11-09-2024
Latest Decision Or Authorization Date
11-10-2024
Processing Time Days
30
Number Of Sites
7
Number Of Participants
13

Sites

Site Name
Unidade Local De Saude De Santo Antonio E.P.E.
Department Name
2806; Medicina Interna
Principal Investigator Name
Ernestina Reis
Principal Investigator Email
ernestinareis.cci@chporto.min-saude.pt
Contact Person Name
Ernestina Reis
Site Name
Unidade Local De Saude Da Guarda E.P.E.
Department Name
2805; Inf. Disease/Infectiology
Principal Investigator Name
Catarina Quinaz
Principal Investigator Email
catarina.quinaz@ulsguarda.min-saude.pt
Contact Person Name
Catarina Quinaz
Site Name
CCAB Centro Clinico Academico Braga Associacao
Department Name
2801; Internal Medicine
Principal Investigator Name
Alexandre Carvalho
Principal Investigator Email
2ca@ccabraga.org
Contact Person Name
Alexandre Carvalho
Contact Person Email
2ca@ccabraga.org
Site Name
Unidade Local De Saude Do Alto Ave E.P.E.
Department Name
2807; Medicina Interna
Principal Investigator Name
Helena Sarmento
Principal Investigator Email
helenasarmento@ulsaave.min-saude.pt
Contact Person Name
Helena Sarmento
Site Name
Unidade Local De Saude De Almada-Seixal E.P.E.
Department Name
2802; Inf. Disease/Infectiology
Principal Investigator Name
Francisco Vale
Principal Investigator Email
francisco.vale@hgo.min-saude.pt
Contact Person Name
Francisco Vale
Site Name
Unidade Local De Saude De Coimbra E.P.E.
Department Name
2803; Medicina Interna
Principal Investigator Name
Diana Marques Ferreira
Principal Investigator Email
10667@chuc.min-saude.pt
Contact Person Name
Diana Marques Ferreira
Contact Person Email
10667@chuc.min-saude.pt
Site Name
Unidade Local De Saude De Gaia/Espinho E.P.E.
Department Name
2804; Medicina Interna
Principal Investigator Name
Margarida Mota
Principal Investigator Email
mmota@ulsge.min-saude.pt
Contact Person Name
Margarida Mota
Contact Person Email
mmota@ulsge.min-saude.pt

Czechia

Earliest CTIS Part Ii Submission Date
24-09-2024
Latest Decision Or Authorization Date
11-10-2024
Processing Time Days
17
Number Of Sites
3
Number Of Participants
8

Sites

Site Name
Nemocnice Kyjov prispevkova organizace
Department Name
1601: Infekcni oddeleni
Principal Investigator Name
Josef Blazek
Principal Investigator Email
blazek.josef@nemkyj.cz
Contact Person Name
Josef Blazek
Contact Person Email
blazek.josef@nemkyj.cz
Site Name
Fakultni Nemocnice Ostrava
Department Name
1603: Klinika infekcniho lekarstvi
Principal Investigator Name
Jiri Sagan
Principal Investigator Email
jiri.sagan@fno.cz
Contact Person Name
Jiri Sagan
Contact Person Email
jiri.sagan@fno.cz
Site Name
Fakultni Nemocnice Brno
Department Name
1604: Klinika infekcnich chorob
Principal Investigator Name
Roman Stebel
Principal Investigator Email
stebel.roman@fnbrno.cz
Contact Person Name
Roman Stebel
Contact Person Email
stebel.roman@fnbrno.cz

Ireland

Earliest CTIS Part Ii Submission Date
20-09-2024
Latest Decision Or Authorization Date
11-10-2024
Processing Time Days
21
Number Of Sites
2
Number Of Participants
3

Sites

Site Name
Our Lady Of Lourdes Hospital
Department Name
2203: Gastroenterology
Principal Investigator Name
John Keohane
Principal Investigator Email
john.keohane@hse.ie
Contact Person Name
John Keohane
Contact Person Email
john.keohane@hse.ie
Site Name
Beaumont Hospital
Department Name
2201: Education and Research Centre
Principal Investigator Name
Sinead O'Donnell
Principal Investigator Email
sineadodonnell@rcsi.ie
Contact Person Name
Sinead O'Donnell
Contact Person Email
sineadodonnell@rcsi.ie

Hungary

Earliest CTIS Part Ii Submission Date
13-09-2024
Latest Decision Or Authorization Date
09-10-2024
Processing Time Days
26
Number Of Sites
5
Number Of Participants
10

Sites

Site Name
Bekes Varmegyei Koezponti Korhaz
Department Name
2105: 4. Belgyógyászat – Gasztroenterológia – Hepatológia
Principal Investigator Name
Márta Varga
Principal Investigator Email
drvargamarta@gmail.com
Contact Person Name
Márta Varga
Contact Person Email
drvargamarta@gmail.com
Site Name
Semmelweis University
Department Name
2103: Belgyógyászati és Haematológiai Klinika
Principal Investigator Name
Emese Mihály
Principal Investigator Email
emesemihaly@hotmail.com
Contact Person Name
Emese Mihály
Contact Person Email
emesemihaly@hotmail.com
Site Name
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
Department Name
2104: I. Belgyógyászat
Principal Investigator Name
László Lóránd Szegedi
Principal Investigator Email
dr.szegedi.laszlo@szszbmk.hu
Contact Person Name
László Lóránd Szegedi
Contact Person Email
dr.szegedi.laszlo@szszbmk.hu
Site Name
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Department Name
2102: Gasztroenterológiai Osztály
Principal Investigator Name
András Káfony
Principal Investigator Email
kafony@gmail.com
Contact Person Name
András Káfony
Contact Person Email
kafony@gmail.com
Site Name
University Of Szeged
Department Name
2101: I. sz. Belgyógyászati Klinika, Infektológia
Principal Investigator Name
Edit Hajdú
Principal Investigator Email
horvathne.hajdu.edit@med.u-szeged.hu
Contact Person Name
Edit Hajdú

Netherlands

Earliest CTIS Part Ii Submission Date
26-09-2024
Latest Decision Or Authorization Date
10-10-2024
Processing Time Days
14
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Leids Universitair Medisch Centrum (LUMC)
Department Name
2602: Medical Microbiology
Principal Investigator Name
Joffrey van Prehn
Principal Investigator Email
j.van_prehn@lumc.nl
Contact Person Name
Joffrey van Prehn
Contact Person Email
j.van_prehn@lumc.nl
Site Name
Universitair Medisch Centrum Utrecht
Department Name
2601: Internal Medicine and Infectious Diseases
Principal Investigator Name
Marjolein Hensgens
Principal Investigator Email
m.p.m.hensgens@umcutrecht.nl
Contact Person Name
Marjolein Hensgens
Contact Person Email
m.p.m.hensgens@umcutrecht.nl

Romania

Earliest CTIS Part Ii Submission Date
10-09-2024
Latest Decision Or Authorization Date
14-10-2024
Processing Time Days
34
Number Of Sites
6
Number Of Participants
23

Sites

Site Name
Spitalul Clinic De Boli Infectioase Cluj-Napoca
Department Name
2903; Infectious diseases
Principal Investigator Name
Mihaela Lupse
Principal Investigator Email
mihaela.lupse@yahoo.com
Contact Person Name
Mihaela Lupse
Contact Person Email
mihaela.lupse@yahoo.com
Site Name
Institutul National De Boli Infectioase Prof.Dr.Matei Bals
Department Name
2905; National Institute of Infectious Diseases "Prof. Dr. Matei Balș"
Principal Investigator Name
Anca STREINU-CERCEL
Principal Investigator Email
anca.streinucercel@gmail.com
Contact Person Name
Anca STREINU-CERCEL
Contact Person Email
anca.streinucercel@gmail.com
Site Name
Centrul Medical Renasterea S.R.L.
Department Name
2904; Policlinic
Principal Investigator Name
Paul Mitrut
Principal Investigator Email
paulmitrut@yahoo.com
Contact Person Name
Paul Mitrut
Contact Person Email
paulmitrut@yahoo.com
Site Name
Spitalul Clinic De Boli Infectioase Sf. Parascheva Iasi
Department Name
2906; Infectious diseases
Principal Investigator Name
Andrei VATA
Principal Investigator Email
andreiandrei@yahoo.com
Contact Person Name
Andrei VATA
Contact Person Email
andreiandrei@yahoo.com
Site Name
Spitalul Clinic De Boli Infectioase Si Tropicale Dr. Victor Babes
Department Name
2902; Infectious diseases
Principal Investigator Name
George Gherlan
Principal Investigator Email
gherlanus@gmail.com
Contact Person Name
George Gherlan
Contact Person Email
gherlanus@gmail.com
Site Name
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
Department Name
2901; ATI
Principal Investigator Name
Ovidiu BEDREAG
Principal Investigator Email
ovidiu.bedreag@yahoo.com
Contact Person Name
Ovidiu BEDREAG
Contact Person Email
ovidiu.bedreag@yahoo.com

Spain

Earliest CTIS Part Ii Submission Date
16-09-2024
Latest Decision Or Authorization Date
08-10-2024
Processing Time Days
22
Number Of Sites
17
Number Of Participants
17

Sites

Site Name
Hospital Germans Trias I Pujol
Department Name
#3013: Enfermedades Infecciosas
Principal Investigator Name
Jose Santos Fernandez
Principal Investigator Email
jrsantos@flsida.org
Contact Person Name
Jose Santos Fernandez
Contact Person Email
jrsantos@flsida.org
Site Name
Hospital Universitario Reina Sofia
Department Name
3002; Enfermedades Infecciosas
Principal Investigator Name
Ángela Cano Yuste
Principal Investigator Email
cayuam@hotmail.com
Contact Person Name
Ángela Cano Yuste
Contact Person Email
cayuam@hotmail.com
Site Name
Bellvitge University Hospital
Department Name
#3014: Gastroenterology
Principal Investigator Name
Jordi Guardiola Capón
Principal Investigator Email
jguardiola@bellvitgehospital.cat
Contact Person Name
Jordi Guardiola Capón
Site Name
Fundacio Assistencial De Mutua De Terrassa Fpc
Department Name
3001; Enfermedades Infecciosas
Principal Investigator Name
Esther Calbo Sebastián
Principal Investigator Email
ecalbo@mutuaterrassa.es
Contact Person Name
Esther Calbo Sebastián
Contact Person Email
ecalbo@mutuaterrassa.es
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
3010; Enfermedades Infecciosas
Principal Investigator Name
Lucía Ramos Merino
Principal Investigator Email
merinolucia19@gmail.com
Contact Person Name
Lucía Ramos Merino
Contact Person Email
merinolucia19@gmail.com
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
3003; 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 La Paz
Department Name
3004; Internal Medicine Service, Infectious Diseases Unit
Principal Investigator Name
Beatriz Diaz Pollan
Principal Investigator Email
bdiazp@salud.madrid.org
Contact Person Name
Beatriz Diaz Pollan
Contact Person Email
bdiazp@salud.madrid.org
Site Name
Hospital Universitario Virgen De Valme
Department Name
3005; Infectious Diseases and Microbiology Unit
Principal Investigator Name
Nicolas Merchante
Principal Investigator Email
nicolasmerchante@gmail.com
Contact Person Name
Nicolas Merchante
Contact Person Email
nicolasmerchante@gmail.com
Site Name
Hospital Universitario Donostia
Department Name
3011; Enfermedades Infecciosas
Principal Investigator Name
Ana Bayona Carlos
Principal Investigator Email
ANA.BAYONACARLOS@osakidetza.eus
Contact Person Name
Ana Bayona Carlos
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
3007; Enfermedades Infecciosas
Principal Investigator Name
Antonio Ramos Martinez
Principal Investigator Email
lucia.ramos.merino@sergas.es
Contact Person Name
Antonio Ramos Martinez
Contact Person Email
lucia.ramos.merino@sergas.es
Site Name
Hospital Clinic De Barcelona
Department Name
3009; Enfermedades Infecciosas
Principal Investigator Name
Alex Soriano Viladomiu
Principal Investigator Email
asoriano@clinic.cat
Contact Person Name
Alex Soriano Viladomiu
Contact Person Email
asoriano@clinic.cat
Site Name
Hospital General Universitario Dr. Balmis
Department Name
3006; 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 General Universitario Gregorio Maranon
Department Name
#3015: Enfermedades Infecciosas
Principal Investigator Name
Elena Reigadas Ramírez
Principal Investigator Email
helenrei@hotmail.com
Contact Person Name
Elena Reigadas Ramírez
Contact Person Email
helenrei@hotmail.com
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
3012; Enfermedades Infecciosas
Principal Investigator Name
Joaquín López-Contreras González
Principal Investigator Email
jlcontreras@santpau.cat
Contact Person Name
Joaquín López-Contreras González
Contact Person Email
jlcontreras@santpau.cat
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
3008; Medicina Interna
Principal Investigator Name
Elena Salamanca Rivera
Principal Investigator Email
elesalamanca@hotmail.com
Contact Person Name
Elena Salamanca Rivera
Contact Person Email
elesalamanca@hotmail.com
Site Name
Hospital Universitario Cordoba (example site listed above)
Department Name
see above entries
Site Name
Hospital (additional listed Spanish sites)
Department Name
see site list

France

Earliest CTIS Part Ii Submission Date
20-09-2024
Latest Decision Or Authorization Date
09-10-2024
Processing Time Days
19
Number Of Sites
10
Number Of Participants
10

Sites

Site Name
Hopital De La Croix-Rousse
Department Name
1802: Gastroenterology
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
CHU De Bordeauxt
Department Name
1804; Internal medecine and infectious diseases
Principal Investigator Name
Fabrice Bonnet
Principal Investigator Email
fabrice.bonnet@chu-bordeaux.fr
Contact Person Name
Fabrice Bonnet
Contact Person Email
fabrice.bonnet@chu-bordeaux.fr
Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
1803; Département d'infectiologie
Principal Investigator Name
Mathieu BLOT
Principal Investigator Email
mathieu.blot@chu-dijon.fr
Contact Person Name
Mathieu BLOT
Contact Person Email
mathieu.blot@chu-dijon.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
1805: Maladies Infectieuses et Tropicales
Principal Investigator Name
David BOUTOILLE
Principal Investigator Email
david.boutoille@chu-nantes.fr
Contact Person Name
David BOUTOILLE
Contact Person Email
david.boutoille@chu-nantes.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
1809: Département des maladies infectieuses et tropicales
Principal Investigator Name
Nathan Peiffer-Smadja
Principal Investigator Email
nathan.peiffer-smadja@aphp.fr
Contact Person Name
Nathan Peiffer-Smadja
Contact Person Email
nathan.peiffer-smadja@aphp.fr
Site Name
Centre Hospitalier Universitaire Reims
Department Name
1801: Département de maladies infectieuses
Principal Investigator Name
Firouze Bani-Sadr
Principal Investigator Email
fbanisadr@chu-reims.fr
Contact Person Name
Firouze Bani-Sadr
Contact Person Email
fbanisadr@chu-reims.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
1807; Département des maladies infectieuses
Principal Investigator Name
adrien lemaignen
Principal Investigator Email
adrien.lemaignen@univ-tours.fr
Contact Person Name
adrien lemaignen
Contact Person Email
adrien.lemaignen@univ-tours.fr
Site Name
GIE Groupe hospitalier Paris Saint-Joseph/Vinci
Department Name
1808: Microbiologie Clinique
Principal Investigator Name
Alban Le Monnier
Principal Investigator Email
alemonnier@hpsj.fr
Contact Person Name
Alban Le Monnier
Contact Person Email
alemonnier@hpsj.fr
Site Name
Assistance Publique Hopitaux De Paris (Garches site)
Department Name
1806: Inf. Disease/Infectiology
Principal Investigator Name
Aurelien Dinh
Principal Investigator Email
aurelien.dinh@aphp.fr
Contact Person Name
Aurelien Dinh
Contact Person Email
aurelien.dinh@aphp.fr
Site Name
CHU De Bordeaux (additional listed site)
Department Name
see above

Denmark

Earliest CTIS Part Ii Submission Date
26-09-2024
Latest Decision Or Authorization Date
07-10-2024
Processing Time Days
11
Number Of Sites
1
Number Of Participants
12

Sites

Site Name
Region Midtjylland
Department Name
1701;Department of Hepatology and Gastroenterology
Principal Investigator Name
Christian Hvas
Principal Investigator Email
chvas@ki.au.dk
Contact Person Name
Christian Hvas
Contact Person Email
chvas@ki.au.dk

Italy

Earliest CTIS Part Ii Submission Date
20-09-2024
Latest Decision Or Authorization Date
09-10-2024
Processing Time Days
19
Number Of Sites
14
Number Of Participants
14

Sites

Site Name
ASST Fatebenefratelli Sacco
Department Name
2407: Dipartimento Malattie Infettive
Principal Investigator Name
Andrea Gori
Principal Investigator Email
andrea.gori@asst-fbf-sacco.it
Contact Person Name
Andrea Gori
Contact Person Email
andrea.gori@asst-fbf-sacco.it
Site Name
Azienda Unita Locale Socio Sanitaria N. 2 Marca Trevigiana
Department Name
2410: U.O. Medicina Generale
Principal Investigator Name
Roberto Sciascia
Principal Investigator Email
roberto.sciascia@aulss2.veneto.it
Contact Person Name
Roberto Sciascia
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
2405: U.O. Malattie Infettive
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 Ospedaliera Universitaria Federico II Di Napoli
Department Name
2406: U.O.C. Malattie Infettive
Principal Investigator Name
Ivan Gentile
Principal Investigator Email
ivan.gentile@unina.it
Contact Person Name
Ivan Gentile
Contact Person Email
ivan.gentile@unina.it
Site Name
Ospedale Isola Tiberina Gemelli Isola
Department Name
2403: UOC Pronto Soccorso, Medicina d’Urgenza e Medicina Generale
Principal Investigator Name
Luigi Carbone
Principal Investigator Email
luigi.carbone@fbf-isola.it
Contact Person Name
Luigi Carbone
Contact Person Email
luigi.carbone@fbf-isola.it
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
2401: S.C.Malattie Infettive
Principal Investigator Name
Paolo Bonfanti
Principal Investigator Email
paolo.bonfanti@unimib.it
Contact Person Name
Paolo Bonfanti
Contact Person Email
paolo.bonfanti@unimib.it
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
2402: Infectious Diseases
Principal Investigator Name
Paolo Sacchi
Principal Investigator Email
p.sacchi@smatteo.pv.it
Contact Person Name
Paolo Sacchi
Contact Person Email
p.sacchi@smatteo.pv.it
Site Name
Ospedale Pediatrico Bambino Gesu
Department Name
2411: UOC Trials Unit
Principal Investigator Name
Laura Cursi
Principal Investigator Email
laura.cursi@opbg.net
Contact Person Name
Laura Cursi
Contact Person Email
laura.cursi@opbg.net
Site Name
Azienda Ospedaliero-Universitaria Ss Antonio E Biagio E Cesare Arrigo
Department Name
2404: S.C. Malattie Infettive
Principal Investigator Name
Cesare Bolla
Principal Investigator Email
cesare.bolla@ospedale.al.it
Contact Person Name
Cesare Bolla
Contact Person Email
cesare.bolla@ospedale.al.it
Site Name
Alessandro Manzoni Hospital
Department Name
2409: S.C.Infectious diseases
Principal Investigator Name
Stefania Piconi
Principal Investigator Email
s.piconi@asst-lecco.it
Contact Person Name
Stefania Piconi
Contact Person Email
s.piconi@asst-lecco.it
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
2408: S.C. di Malattie Infettive
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 Di Pavia (San Matteo)
Department Name
see above
Site Name
Other listed Italian sites
Department Name
see site list
Site Name
Azienda Ospedaliero Universitaria Di Pisa (duplicate listing)
Department Name
see above

Belgium

Earliest CTIS Part Ii Submission Date
20-09-2024
Latest Decision Or Authorization Date
11-10-2024
Processing Time Days
21
Number Of Sites
3
Number Of Participants
5

Sites

Site Name
Cliniques Universitaires Saint-Luc
Department Name
1301: Internal Medicine
Principal Investigator Name
Leïla Belkhir
Principal Investigator Email
Leila.Belkhir@uclouvain.be
Contact Person Name
Leïla Belkhir
Contact Person Email
Leila.Belkhir@uclouvain.be
Site Name
Universitair Ziekenhuis Gent
Department Name
1302: Infectieziekten
Principal Investigator Name
Marie-Angelique De Scheerder
Principal Investigator Email
MarieAngelique.DeScheerder@ugent.be
Contact Person Name
Marie-Angelique De Scheerder
Site Name
Hopital Erasme
Department Name
1303: Maladies Infectieuses
Principal Investigator Name
Maya Hites
Principal Investigator Email
maya.hites@erasme.ulb.ac.be
Contact Person Name
Maya Hites
Contact Person Email
maya.hites@erasme.ulb.ac.be

Germany

Earliest CTIS Part Ii Submission Date
06-09-2024
Latest Decision Or Authorization Date
10-10-2024
Processing Time Days
34
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
University Hospital Cologne AöR
Department Name
2001;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
Epimed Gesellschaft fuer epidemiologische und klinische Forschung in der Medizin mbH
Department Name
2003; NA
Principal Investigator Name
Keikawus Arastéh
Principal Investigator Email
safety@epimed.org
Contact Person Name
Keikawus Arastéh
Contact Person Email
safety@epimed.org
Site Name
Goethe University Frankfurt
Department Name
2002;Inf. Disease/Infectiology
Principal Investigator Name
Maria Vehreschild
Principal Investigator Email
maria.vehreschild@kgu.de
Contact Person Name
Maria Vehreschild
Contact Person Email
maria.vehreschild@kgu.de

Bulgaria

Earliest CTIS Part Ii Submission Date
10-09-2024
Latest Decision Or Authorization Date
14-10-2024
Processing Time Days
34
Number Of Sites
7
Number Of Participants
20

Sites

Site Name
MBAL Dr. Ivan Seliminski - Sliven AD
Department Name
1501: Department for Gastroenterology
Principal Investigator Name
Tsvetan Danchev
Principal Investigator Email
dr.tsvetan.danchev@gmail.com
Contact Person Name
Tsvetan Danchev
Contact Person Email
dr.tsvetan.danchev@gmail.com
Site Name
Multiprofile Hospital For Active Treatment Sveti Nikolay Chuditvorets EOOD
Department Name
1502: Department for Internal Diseases
Principal Investigator Name
Iliyan Simeonov
Principal Investigator Email
iliyan.simeonov@fidelissmo.com
Contact Person Name
Iliyan Simeonov
Contact Person Email
iliyan.simeonov@fidelissmo.com
Site Name
Medicinski Centar Hipokrat-N EOOD
Department Name
1506; NA
Principal Investigator Name
Nikolay Nikolov
Principal Investigator Email
nikolay_nikolov@gmail.com
Contact Person Name
Nikolay Nikolov
Contact Person Email
nikolay_nikolov@gmail.com
Site Name
Multiprofile Hospital For Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOOD
Department Name
1503: First Internal Department
Principal Investigator Name
Ilko Kosturkov
Principal Investigator Email
ikosturkov@mcmedicaplus.com
Contact Person Name
Ilko Kosturkov
Contact Person Email
ikosturkov@mcmedicaplus.com
Site Name
University Multiprofile Hospital For Active Treatment Burgas AD
Department Name
1508: Department for Gastroenterology
Principal Investigator Name
Velina Pramatarova
Principal Investigator Email
dr.velina.pramatarova@gmail.com
Contact Person Name
Velina Pramatarova
Site Name
Medical Center Excelsior OOD
Department Name
1504; NA
Principal Investigator Name
Ivan Lutakov
Principal Investigator Email
ivan.lutakov@gmail.com
Contact Person Name
Ivan Lutakov
Contact Person Email
ivan.lutakov@gmail.com
Site Name
Other Bulgarian listed sites
Department Name
see site list

Sponsor

Primary sponsor

Full Name
Vedanta Biosciences Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Parexel International (IRL) Limited
Responsibilities
Clinical research services and sponsor duties (codes: 1,10,11,12,13,2,5,6,7,8) as listed in trial record; central contact Clinicaltrial.Enquiries@parexel.com

Third parties

  • {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"Sponsor duties codes: 1,10,11,12,13,2,5,6,7,8","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
VE303
Active Substance
CLOSTRIDIA, CLUSTER XIVA, STRAIN RELATIVE CLOSTRIDIUM_Q SYMBIOSUM, LIVE; CLOSTRIDIA, CLUSTER XIVA, STRAIN RELATIVE ENTEROCLOSTER BOLTEAE, LIVE; CLOSTRIDIA, CLUSTER XIVA, STRAIN RELATIVE SELLIMONAS INTESTINALIS, LIVE; CLOSTRIDIA, CLUSTER IV, STRAIN RELATIVE FLAVONIFRACTOR PLAUTII, LIVE; CLOSTRIDIA, CLUSTER XIVA, STRAIN RELATIVE BLAUTIA SP001304935, LIVE; BACILLI, CLUSTER XVII, STRAIN RELATIVE CLOSTRIDIUM_AQ INNOCUUM, LIVE; CLOSTRIDIA, CLUSTER XIVA, STRAIN RELATIVE DOREA_A LONGICATENA, LIVE; CLOSTRIDIA, CLUSTER IV, STRAIN RELATIVE ANAEROTRUNCUS COLIHOMINIS, LIVE
Modality
Other
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised for clinical trial (MIA number: IMP11566/00001; DE_BB_01_MIA_2024_0015)
Frequency
Daily oral administration for 14 consecutive days
Maximum Dose
maxDailyDoseAmount 3 (DF dosage form); maxTotalDoseAmount 42 (DF dosage form) over 14 days
Investigational Product Name
Placebo capsules containing microcrystalline cellulose (visually identical to VE303)
Active Substance
microcrystalline cellulose (placebo formulation)
Modality
Other
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised for clinical trial (MIA number: IMP11566/00001; DE_BB_01_MIA_2024_0015)
Frequency
Daily oral administration for 14 consecutive days

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