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

In reclutamentoAccetta partecipanti ora, secondo la scheda del registro.

Contatta questo studio

In breve

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 partecipanti ricercati215 centri24 paesi

Categorie

Malattie infettive80%Gastroenterologia ed epatologia20%

Registrato in 1 registro

ClinicalTrials.govNCT06237452Apri questa scheda su ClinicalTrials.govSincronizzato 5 giorni fa

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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.

Sintesi

Patologie

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

Idoneità

Idoneità
Sesso	Tutti
Età	12 Years – Nessun massimo
Volontari sani	No

Idoneità come riportata nel 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

Idoneità in frasi semplici

I criteri di questa scheda non sono ancora stati suddivisi in affermazioni distinte. Il testo del registro qui sopra è completo ed è la versione autorevole.

Disegno dello studio

Disegno dello studio
Tipo di studio	Interventistico
Fase	Fase 3
Assegnazione	Randomizzata
Modello di intervento	PARALLEL
Finalità principale	PREVENTION
Mascheramento	QUADRUPLE (4)
Arruolamento	852 partecipanti ricercati

Sponsor e collaboratori

Vedanta Biosciences, Inc. Sponsor

Bracci e interventi

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.

Interventi

Biologico 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.
Biologico 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.

Esiti misurati

Esito primario
CDI Recurrence Rate at Week 8
Proportion of participants with laboratory-confirmed CDI recurrence before or at Week 8.
Orizzonte temporale 8 weeks

Date

Date
Data di inizio	20 maggio 2024 (effettiva)
Conclusione primaria	1 giugno 2027 (stimata)
Conclusione	1 ottobre 2027 (stimata)
Prima pubblicazione	1 febbraio 2024 (effettiva)
Ultimo aggiornamento	14 settembre 2026
Risultati pubblicati	Non indicato nella scheda del registro
Stato verificato l'ultima volta	settembre 2026

«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.

Centri

155 centri stanno reclutando

Australia

Australia
Struttura	Città	Stato o regione	Stato
Monash Health	Clayton	Victoria	Ritirato
Concord Repatriation General Hospital	Concord	New South Wales	Ritirato
Melbourne Health	Parkville	Victoria	Ritirato
Westmead Hospital	Westmead	New South Wales	Ritirato

Belgium

Belgium
Struttura	Città	Stato
Erasme University Hospital - Infectiology Department	Anderlecht	In reclutamento
Universite Catholique De Louvain and Cliniques Universitaires Saint-Luc	Brussels	In reclutamento
Universitair Ziekenhuis Gent	Ghent	In reclutamento

Brazil

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

Bulgaria

Bulgaria
Struttura	Città	Stato o regione	Stato
UMHAT Burgas AD	Burgas		Ritirato
Multiprofile Hospital for Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOOD	Gorna Oryahovitsa		In reclutamento
Multiprofile Hospital for Active Treatment Sveti Nikolay Chuditvorets EOOD	Lom		Ritirato
Medicinski centar Hipokrat-N EOOD	Plovdiv		Ritirato
MHAT Dr.Ivan Seliminski - Sliven Ltd.	Sliven		Ritirato
Medical Center Excelsior OOD, Base 1	Sofia	Sofia-Grad	Ritirato

Canada

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

Czechia

Czechia
Struttura	Città	Stato o regione	Stato
Fakultni nemocnice Brno	Brno	Brno-město	Ritirato
Nemocnice Kyjov, p.o.	Kyjov		Ritirato
Fakultni Nemocnice Ostrava	Ostrava-Poruba		Ritirato

Denmark

Denmark
Struttura	Città	Stato o regione	Stato
Aarhus University Hospital	Aarhus	Central Jutland	In reclutamento

France

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

Georgia

Georgia
Struttura	Città	Stato o regione	Stato
ISR-GEO Med Res Clin Healthycore	Tbilisi	K'alak'i T'bilisi	In reclutamento
LTD "Academician Vakhtang Bochorishvili Clinic"	Tbilisi	K'alak'i T'bilisi	In reclutamento
LTD "Aversi Clinic"	Tbilisi	K'alak'i T'bilisi	In reclutamento
LTD "Emergency Cardiology Center named by Acad.G.Chapidze"	Tbilisi		In reclutamento

Germany

Germany
Struttura	Città	Stato o regione	Stato
Epimed GmbH	Berlin	State of Berlin	In reclutamento

Nella scheda del registro sono indicati altri 165 centri.

Documenti dello studio

In questa scheda del registro non sono collegati documenti.

Modifiche nel tempo

Non è stata registrata alcuna modifica da quando abbiamo acquisito questa scheda.

Viene registrata una modifica ogni volta che lo sponsor aggiorna la scheda del registro. Stato, date, arruolamento e centri compaiono qui man mano che cambiano.

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

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