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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

قيد التجنيديقبل مشاركين الآن، وفقاً لسجل السجل.
التواصل مع هذه الدراسة

باختصار

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…

المرحلة 3مطلوب 852 مشاركاً215 موقعاً24 دولة

الفئات

الأمراض المُعدية80%أمراض الجهاز الهضمي والكبد20%

مسجَّلة في سجل واحد

يمكن أن تُسجَّل دراسة واحدة في عدة سجلات. نعرضها مرة واحدة ونربط بكل سجل نحتفظ به.

تُعرض معلومات التجربة كما نشرها السجل، بلغتها الأصلية.

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تسجيل الدخول أو أنشئ حسابًا لتسجيل اهتمامك ومتابعة هذه الدراسة.

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.

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

ملخص

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 identical for Stage 1 (recurrent CDI) and Stage 2 (high-risk primary CDI).

الحالات

  • 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

الأهلية

الجنسالجميع
الأعمار12 Years – لا حد أقصى
المتطوعون الأصحّاءلا

الأهلية كما كُتبت في السجل

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

الأهلية في عبارات بسيطة

لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.

تصميم الدراسة

نوع الدراسةتدخّلية
المرحلةالمرحلة 3
التخصيصمعشّاة
نموذج التدخّلPARALLEL
الغرض الأساسيPREVENTION
التعميةQUADRUPLE (4)
التجنيدمطلوب 852 مشاركاً

الجهة الراعية والمتعاونون

  • Vedanta Biosciences, Inc. الجهة الراعية

الأذرع والتدخلات

  • 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.

التدخلات

  • منتج بيولوجي 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.

  • منتج بيولوجي 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.

مقاييس النتائج

  1. مقياس النتيجة الأولي

    CDI Recurrence Rate at Week 8

    Proportion of participants with laboratory-confirmed CDI recurrence before or at Week 8.

    الإطار الزمني 8 weeks

التواريخ

تاريخ البدء20 مايو 2024 (فعلي)
الإتمام الأولي1 يونيو 2027 (تقديري)
الإتمام1 أكتوبر 2027 (تقديري)
أول نشر1 فبراير 2024 (فعلي)
آخر تحديث14 سبتمبر 2026
النتائج منشورةغير مذكور في سجل السجل
آخر تأكيد للحالةسبتمبر 2026

فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.

المواقع

155 موقعاً قيد التجنيد

Australia

المنشأةالمدينةالولاية أو المنطقةالحالة
Monash HealthClaytonVictoriaمسحوب
Concord Repatriation General HospitalConcordNew South Walesمسحوب
Melbourne HealthParkvilleVictoriaمسحوب
Westmead HospitalWestmeadNew South Walesمسحوب

Belgium

المنشأةالمدينةالولاية أو المنطقةالحالة
Erasme University Hospital - Infectiology DepartmentAnderlechtقيد التجنيد
Universite Catholique De Louvain and Cliniques Universitaires Saint-LucBrusselsقيد التجنيد
Universitair Ziekenhuis GentGhentقيد التجنيد

Brazil

المنشأةالمدينةالولاية أو المنطقةالحالة
CCIH - Consultoria em Controle de Infecção Hospitalar LtdaBelo HorizonteMinas Geraisقيد التجنيد
Fundacao Universidade de Caxias do Sul - Hospital Geral de Caxias do SulCaxias do SulRio Grande do Sulقيد التجنيد
Hospital Nossa Senhora das GraçasCuritibaParanáقيد التجنيد
CPCLIN - Centro de Estudos e Pesquisas em Molestias Infecciosas - Pesquisa ClínicaNatalRio Grande do Norteقيد التجنيد
Hospital de Clinicas de Porto Alegre - UFRGSPorto AlegreRio Grande do Sulقيد التجنيد
Associação Educadora São Carlos AESC - Hospital Mãe de Deus - Centro de PesquisaPorto AlegreRio Grande do Sulقيد التجنيد
Hospital Alemao Oswaldo CruzSão PauloSão Pauloقيد التجنيد

Bulgaria

المنشأةالمدينةالولاية أو المنطقةالحالة
UMHAT Burgas ADBurgasمسحوب
Multiprofile Hospital for Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOODGorna Oryahovitsaقيد التجنيد
Multiprofile Hospital for Active Treatment Sveti Nikolay Chuditvorets EOODLomمسحوب
Medicinski centar Hipokrat-N EOODPlovdivمسحوب
MHAT Dr.Ivan Seliminski - Sliven Ltd.Slivenمسحوب
Medical Center Excelsior OOD, Base 1SofiaSofia-Gradمسحوب

Canada

المنشأةالمدينةالولاية أو المنطقةالحالة
Alberta Health Services (AHS) - Foothills Medical CentreCalgaryAlbertaقيد التجنيد
INTERMED groupe santéChicoutimiQuebecقيد التجنيد
University of AlbertaEdmontonAlbertaقيد التجنيد
Research St. Josephs HamiltonHamiltonOntarioقيد التجنيد
St. Joseph's Hospital - LondonLondonOntarioقيد التجنيد
The Moncton HospitalMonctonNew Brunswickقيد التجنيد
Centre Hospitalier de l Universite Laval (CHUL)QuébecQuebecقيد التجنيد
CaRe ClinicRed DeerAlbertaقيد التجنيد
Viable Clinical Research CorporationScarborough VillageOntarioمسحوب
NL Health ServicesSt. John'sNewfoundland and Labradorقيد التجنيد
University Health NetworkTorontoOntarioقيد التجنيد
Vancouver Coastal Health Research Institute Clinical Research UnitVancouverBritish Columbiaقيد التجنيد

Czechia

المنشأةالمدينةالولاية أو المنطقةالحالة
Fakultni nemocnice BrnoBrnoBrno-městoمسحوب
Nemocnice Kyjov, p.o.Kyjovمسحوب
Fakultni Nemocnice OstravaOstrava-Porubaمسحوب

Denmark

المنشأةالمدينةالولاية أو المنطقةالحالة
Aarhus University HospitalAarhusCentral Jutlandقيد التجنيد

France

المنشأةالمدينةالولاية أو المنطقةالحالة
CHU Bordeaux - Hopital Saint Andre Service de medecine interne et maladies infectieusesBordeaux CedexHauts-de-Franceقيد التجنيد
Hôpital du BocageDijonFranche-Comtéقيد التجنيد
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopitaux Universitaires Paris Ile-de-France Ouest - Raymond-PoincareGarchesHauts-de-Seineقيد التجنيد
Hospital St. JosephLes ParisAuvergne-Rhône-Alpesقيد التجنيد
Hôpital De La Croix Rousse - GastroenterologyLyonRhoneقيد التجنيد
CHU de Nantes - Hôtel DieuNantesLoire-Atlantiqueقيد التجنيد
Assistance Publique Hôpitaux de Paris Hôpital Bichat- Claude Bernard - Département des maladies infectieuses et tropicalesParisParisقيد التجنيد
Centre Hospitalier Universitaire (CHU) de Reims - Hopital Robert DebreParisGrand Estقيد التجنيد
Chru De ToursToursقيد التجنيد

Georgia

المنشأةالمدينةالولاية أو المنطقةالحالة
ISR-GEO Med Res Clin HealthycoreTbilisiK'alak'i T'bilisiقيد التجنيد
LTD "Academician Vakhtang Bochorishvili Clinic"TbilisiK'alak'i T'bilisiقيد التجنيد
LTD "Aversi Clinic"TbilisiK'alak'i T'bilisiقيد التجنيد
LTD "Emergency Cardiology Center named by Acad.G.Chapidze"Tbilisiقيد التجنيد

Germany

المنشأةالمدينةالولاية أو المنطقةالحالة
Epimed GmbHBerlinState of Berlinقيد التجنيد

يُدرَج 165 موقعاً إضافياً في سجل السجل.

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

لم تُسجَّل أي تغييرات منذ أن أدرجنا هذا السجل لأول مرة.

يُسجَّل تغيير في كل مرة تحدّث فيها الجهة الراعية سجل السجل. تظهر هنا الحالة والتواريخ والتجنيد والمواقع كلما تغيّرت.

السجل: ClinicalTrials.gov · NCT########

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