NCT06237452ClinicalTrials.gov

VE303 for Prevention of Recurrent Clostridioides Difficile Infection

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of VE303 for Prevention of Recurrent Clostridioides Difficile Infection

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En resumen

The overall objective of the RESTORATiVE303 study is to evaluate the safety and the Clostridioides difficile infection (CDI) recurrence rate at Week 8 in participants who receive a 14-day course of VE303 or matching placebo. The objectives and endpoints are…

Fase 3852 participantes buscados215 centros24 países

Categorías

Enfermedades infecciosas80%Gastroenterología y hepatología20%

Registrado en 1 registro

ClinicalTrials.govNCT06237452Abrir este registro en ClinicalTrials.govSincronizado hace 5 días

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2024-02-01; recorded start 2024-05-20
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Present: Uses blinding (masking)A masking level is recorded in the record
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 3 other studies in this databaseCounted from the lead sponsor named in the record (Vedanta Biosciences, Inc.)
Not stated: No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database

The record lists 10 conditions.
Lead sponsor type recorded as: industry.
Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourDEFINITIVE

A definitive-grade design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation20/20
Participants are randomly allocated between arms
Blinding20/20
Quadruple-blind
Control arm13/15
Placebo / sham control arm
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type7/10
Clinical-event endpoint
Multi-centre8/8
Multi-centre: 215 sites
Data monitoring committee7/7
A data monitoring committee is in place
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleLARGE

A large study, international in scope: 852 participants (target), run at 215 sites, across 24 countries.

How this score is built

Enrolment29/40
852 participants (target)
Site count25/25
215 sites
Country count15/15
24 countries
Planned duration8/10
Planned over about 41 months
Sponsor scale2/10
Vedanta Biosciences, Inc. has led 4 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Resumen

Afecciones

Clostridium Difficile
Clostridium Difficile Infections
Clostridium Difficile Infection Recurrence
Clostridioides Difficile Infection
Clostridioides Difficile Infection Recurrence
CDI
C. Diff Infection
Recurrent Clostridium Difficile Infection
C.Difficile Diarrhea
Diarrhea Infectious

Elegibilidad

Elegibilidad
Sexo	Todos
Edades	12 Years – Sin máximo
Voluntarios sanos	No

Elegibilidad tal como figura en el registro

Key Inclusion Criteria (For enrollment in Stage 1: recurrent CDI population): * Age ≥ 12 years where permitted, and ≥ 18 years in other locations, with a laboratory-confirmed qualifying episode of CDI and at least 1 prior occurrence within the last 6 months Key Inclusion Criteria (For enrollment in Stage 2: primary CDI with high-risk for recurrence population): * Age ≥ 75 years with a laboratory-confirmed qualifying episode of CDI * OR age ≥ 12 years where permitted, and ≥ 18 years in other locations, with least two of the following risk factors: 1. Age ≥ 65 years 2. Kidney dysfunction, defined as estimated creatinine clearance \< 60 mL/min/1.73 m\^2 at the time of the qualifying CDI episode 3. 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 4. History of a prior CDI episode between 6 and 12 months prior to enrollment 5. Immunosuppression due to an underlying disease or its treatment 6. Has undergone solid organ or hematopoietic stem cell transplantation Key Inclusion Criteria (For enrollment in Stage 1 or 2): * The qualifying episode of CDI must meet all the following criteria: 1. New onset of ≥ 3 unformed bowel movements (ie, Types 5 to 7 on the Bristol stool scale) within 24 hours for 2 consecutive days 2. CDI symptoms started within 4 weeks prior to initiation of standard of care (SoC) antibiotic therapy for CDI 3. 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 enzyme immunoassay (EIA) for toxin A/B and glutamate dehydrogenase (GDH) with polymerase chain reaction (PCR) reflex testing for discordant EIA/GDH results, performed at either a local laboratory or the central laboratory 4. Diarrhea considered unlikely to have another etiology * Prior to receiving any study medication, the participant should: 1. Receive and complete a course of SoC antibiotic therapy for at least 10 days, up to a maximum of 28 days (Note: choice of agent is at the physician's discretion and antibiotic tapering is not allowed). It is permissible for decentralized participants to be randomized during SoC antibiotic administration. 2. Meet the criterion of a successful clinical response, defined attaining symptomatic control of the qualifying CDI episode, ie, \< 3 loose/unformed bowel movements per 24 hours for at least 2 consecutive days * 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 * Recovered from any complications of severe or fulminant CDI and be clinically stable by the time of randomization Key Exclusion Criteria (For both Stage 1 and Stage 2): * 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 * Known or suspected toxic megacolon or small bowel ileus at the time of randomization * History of confirmed celiac disease, inflammatory bowel disease, microscopic colitis, short gut, GI tract fistulas, or a recent episode (within 6 months of screening) of intestinal ischemia or ischemic colitis * Receipt of bezlotoxumab during the course of SoC antibiotic treatment for the qualifying CDI episode * Use of antidiarrheal drugs (eg, loperamide, diphenoxylate) within 3 days prior to the planned first dose of study drug * Anticipated administration of oral or parenteral antibacterial therapy for a non-CDI indication after randomization through Week 24 (end of study) * Probiotics, whether characterized as a dietary/food supplement, or a drug, are prohibited within 2 days before starting study drug and through the dosing period. (Note: consumption of food-based products such as yogurt, kombucha, and kefir are permitted.) * 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 × 10\^9 cells/L

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Diseño del estudio
Tipo de estudio	De intervención
Fase	Fase 3
Asignación	Aleatorizado
Modelo de intervención	PARALLEL
Propósito principal	PREVENTION
Enmascaramiento	QUADRUPLE (4)
Inscripción	852 participantes buscados

Patrocinador y colaboradores

Vedanta Biosciences, Inc. Patrocinador

Grupos e intervenciones

VE303EXPERIMENTAL
Subjects assigned to the VE303 arm will take 3 capsules containing VE303 per day for 14 days after completing 10 to 21 days of standard of care antibiotic treatment for the qualifying CDI episode.
PlaceboPLACEBO_COMPARATOR
Subjects assigned to the placebo arm will take 3 placebo capsules per day for 14 days after completing 10 to 21 days of standard of care antibiotic treatment for the qualifying CDI episode.

Intervenciones

Biológico Placebo
Placebo capsules contain microcrystalline cellulose. Placebo capsules are visually identical to and not discernible from VE303 capsules. Placebo capsules will not contain any VE303 drug product.
Biológico VE303
VE303 is a live biotherapeutic product (LBP) consisting of 8 clonally derived, nonpathogenic, nontoxigenic, commensal bacteria strains manufactured under Good Manufacturing Practices (GMP) conditions.

Variables de resultado

Variable de resultado principal
CDI Recurrence Rate at Week 8
Proportion of participants with laboratory-confirmed CDI recurrence before or at Week 8.
Plazo 8 weeks

Fechas

Fechas
Fecha de inicio	20 de mayo de 2024 (real)
Finalización principal	1 de junio de 2027 (estimada)
Finalización	1 de octubre de 2027 (estimada)
Primera publicación	1 de febrero de 2024 (real)
Última actualización	14 de septiembre de 2026
Resultados publicados	No indicado en el registro
Estado verificado por última vez	septiembre de 2026

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

155 centros están en reclutamiento

Australia

Australia
Centro	Ciudad	Estado o región	Estado
Monash Health	Clayton	Victoria	Retirado
Concord Repatriation General Hospital	Concord	New South Wales	Retirado
Melbourne Health	Parkville	Victoria	Retirado
Westmead Hospital	Westmead	New South Wales	Retirado

Belgium

Belgium
Centro	Ciudad	Estado
Erasme University Hospital - Infectiology Department	Anderlecht	En reclutamiento
Universite Catholique De Louvain and Cliniques Universitaires Saint-Luc	Brussels	En reclutamiento
Universitair Ziekenhuis Gent	Ghent	En reclutamiento

Brazil

Brazil
Centro	Ciudad	Estado o región	Estado
CCIH - Consultoria em Controle de Infecção Hospitalar Ltda	Belo Horizonte	Minas Gerais	En reclutamiento
Fundacao Universidade de Caxias do Sul - Hospital Geral de Caxias do Sul	Caxias do Sul	Rio Grande do Sul	En reclutamiento
Hospital Nossa Senhora das Graças	Curitiba	Paraná	En reclutamiento
CPCLIN - Centro de Estudos e Pesquisas em Molestias Infecciosas - Pesquisa Clínica	Natal	Rio Grande do Norte	En reclutamiento
Hospital de Clinicas de Porto Alegre - UFRGS	Porto Alegre	Rio Grande do Sul	En reclutamiento
Associação Educadora São Carlos AESC - Hospital Mãe de Deus - Centro de Pesquisa	Porto Alegre	Rio Grande do Sul	En reclutamiento
Hospital Alemao Oswaldo Cruz	São Paulo	São Paulo	En reclutamiento

Bulgaria

Bulgaria
Centro	Ciudad	Estado o región	Estado
UMHAT Burgas AD	Burgas		Retirado
Multiprofile Hospital for Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOOD	Gorna Oryahovitsa		En reclutamiento
Multiprofile Hospital for Active Treatment Sveti Nikolay Chuditvorets EOOD	Lom		Retirado
Medicinski centar Hipokrat-N EOOD	Plovdiv		Retirado
MHAT Dr.Ivan Seliminski - Sliven Ltd.	Sliven		Retirado
Medical Center Excelsior OOD, Base 1	Sofia	Sofia-Grad	Retirado

Canada

Canada
Centro	Ciudad	Estado o región	Estado
Alberta Health Services (AHS) - Foothills Medical Centre	Calgary	Alberta	En reclutamiento
INTERMED groupe santé	Chicoutimi	Quebec	En reclutamiento
University of Alberta	Edmonton	Alberta	En reclutamiento
Research St. Josephs Hamilton	Hamilton	Ontario	En reclutamiento
St. Joseph's Hospital - London	London	Ontario	En reclutamiento
The Moncton Hospital	Moncton	New Brunswick	En reclutamiento
Centre Hospitalier de l Universite Laval (CHUL)	Québec	Quebec	En reclutamiento
CaRe Clinic	Red Deer	Alberta	En reclutamiento
Viable Clinical Research Corporation	Scarborough Village	Ontario	Retirado
NL Health Services	St. John's	Newfoundland and Labrador	En reclutamiento
University Health Network	Toronto	Ontario	En reclutamiento
Vancouver Coastal Health Research Institute Clinical Research Unit	Vancouver	British Columbia	En reclutamiento

Czechia

Czechia
Centro	Ciudad	Estado o región	Estado
Fakultni nemocnice Brno	Brno	Brno-město	Retirado
Nemocnice Kyjov, p.o.	Kyjov		Retirado
Fakultni Nemocnice Ostrava	Ostrava-Poruba		Retirado

Denmark

Denmark
Centro	Ciudad	Estado o región	Estado
Aarhus University Hospital	Aarhus	Central Jutland	En reclutamiento

France

France
Centro	Ciudad	Estado o región	Estado
CHU Bordeaux - Hopital Saint Andre Service de medecine interne et maladies infectieuses	Bordeaux Cedex	Hauts-de-France	En reclutamiento
Hôpital du Bocage	Dijon	Franche-Comté	En reclutamiento
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopitaux Universitaires Paris Ile-de-France Ouest - Raymond-Poincare	Garches	Hauts-de-Seine	En reclutamiento
Hospital St. Joseph	Les Paris	Auvergne-Rhône-Alpes	En reclutamiento
Hôpital De La Croix Rousse - Gastroenterology	Lyon	Rhone	En reclutamiento
CHU de Nantes - Hôtel Dieu	Nantes	Loire-Atlantique	En reclutamiento
Assistance Publique Hôpitaux de Paris Hôpital Bichat- Claude Bernard - Département des maladies infectieuses et tropicales	Paris	Paris	En reclutamiento
Centre Hospitalier Universitaire (CHU) de Reims - Hopital Robert Debre	Paris	Grand Est	En reclutamiento
Chru De Tours	Tours		En reclutamiento

Georgia

Georgia
Centro	Ciudad	Estado o región	Estado
ISR-GEO Med Res Clin Healthycore	Tbilisi	K'alak'i T'bilisi	En reclutamiento
LTD "Academician Vakhtang Bochorishvili Clinic"	Tbilisi	K'alak'i T'bilisi	En reclutamiento
LTD "Aversi Clinic"	Tbilisi	K'alak'i T'bilisi	En reclutamiento
LTD "Emergency Cardiology Center named by Acad.G.Chapidze"	Tbilisi		En reclutamiento

Germany

Germany
Centro	Ciudad	Estado o región	Estado
Epimed GmbH	Berlin	State of Berlin	En reclutamiento

En el registro figuran 165 centros más.

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

No se han registrado cambios desde que incorporamos este registro por primera vez.

Se registra un cambio cada vez que el patrocinador actualiza el registro. El estado, las fechas, la inscripción y los centros aparecen aquí a medida que cambian.

Registro: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT06237452