- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02299570
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD2)
23. december 2020 opdateret af: Rebiotix Inc.
A Phase 2B Prospective, Randomized, Double-blinded, Placebo-controlled Clinical Study Demonstrating the Efficacy and Safety of Rebiotix RBX2660 (Microbiota Suspension) for the Treatment of Recurrent Clostridium Difficile Infection
This is the first prospective, multi-center, double-blinded, randomized controlled study of a microbiota suspension derived from intestinal microbes.
Patients who have had at least two recurrences of C. difficile infection (CDI) after a primary episode and have completed at least two rounds of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization may be eligible for the study.
Patients whose CDI returns in less than 8 weeks after the last assigned study treatment may be eligible to receive up to 2 treatments with RBX2660 in the open-label portion of the study.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Detaljeret beskrivelse
This is the first prospective, multi-center, double-blinded, randomized controlled study of a microbiota suspension derived from intestinal microbes.
The primary assessments for this study are (i) efficacy of RBX2660 compared to placebo at 8 weeks and (ii) safety via assessment of adverse events.
Study visits are at 1-, 4- and 8-weeks after treatment with additional follow-up at 3, 6 12 and 24 months post treatment.
Patients who have had at least two recurrences of C. difficile infection (CDI) after a primary episode and have completed at least two rounds of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization may be eligible for the study.
Patients whose CDI returns in less than 8 weeks after the last assigned study treatment may be eligible to receive up to 2 treatments with RBX2660 in the open-label portion of the study.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
150
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 1M9
- University of British Columbia
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Ontario
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Hamilton, Ontario, Canada, L8N 4A6
- St. Joseph's Hospital
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Arizona
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Phoenix, Arizona, Forenede Stater, 85054
- Mayo Clinic Arizona
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Colorado
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Aurora, Colorado, Forenede Stater, 80045
- University of Colorado
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Florida
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Jacksonville, Florida, Forenede Stater, 32256
- Borland-Groover Clinic
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Idaho
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Idaho Falls, Idaho, Forenede Stater, 83404
- Grand Teton Research Group
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Illinois
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Chicago, Illinois, Forenede Stater, 60637
- University of Chicago
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Chicago, Illinois, Forenede Stater, 60153
- Loyola University Chicago
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Indiana
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Indianapolis, Indiana, Forenede Stater, 46260
- Infectious Diseases of Indiana
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Maryland
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Chevy Chase, Maryland, Forenede Stater, 20815
- Chevy Chase Clinical Research
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Michigan
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Detroit, Michigan, Forenede Stater, 48202
- Henry Ford Health System
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Minnesota
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Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic Minnesota
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Saint Paul, Minnesota, Forenede Stater, 55101
- Regions Hospital
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Missouri
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Saint Louis, Missouri, Forenede Stater, 63110
- Washington University School of Medicine
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New York
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Flushing, New York, Forenede Stater, 11355
- New York Hospital Queens
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New York, New York, Forenede Stater, 10065
- New York-Presbyterian Hospital/Weill Cornell Medical College
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Rochester, New York, Forenede Stater, 14618
- Gastroenterology Group of Rochester
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North Dakota
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Fargo, North Dakota, Forenede Stater, 58122
- Sanford Health
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Ohio
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Cleveland, Ohio, Forenede Stater, 44106
- Louis Stokes Cleveland VA Medical Center
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Lima, Ohio, Forenede Stater, 45801
- Regional Infectious Diseases and Infusion Center
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- Hospital of the University of Pennsylvania
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- ≥ 18 years
- Medical record documentation of recurrent CDI either: a) at least two recurrences after a primary episode and has completed at least two rounds of standard-of-care oral antibiotic therapy or b) has had at least two episodes of severe CDI resulting in hospitalization.
- Documented history that the subject's recurrent CDI is controlled while on antibiotics even if the subject is not currently on antibiotics.
- A positive stool test for the presence of C. difficile within 60 days prior to enrollment.
Exclusion Criteria:
- A known history of continued C. difficile diarrhea while taking on a course of antibiotics prescribed for CDI treatment.
- Requires antibiotic therapy for a condition other than recurrent CDI.
- Previous fecal transplant prior to study enrollment.
- History of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's disease, or microscopic colitis.
- History of irritable bowel syndrome (IBS).
- History of chronic diarrhea.
- History of celiac disease.
- Colostomy.
- Planned surgery requiring perioperative antibiotics within 6 months of study enrollment.
- Life expectancy of < 12 months.
- Compromised immune system.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: Group A
Two enemas of RBX2660 (microbiota suspension) administered 7 days apart
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A suspension of intestinal microbes
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Placebo komparator: Group B
Two enemas of placebo administered 7 days apart
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A suspension of saline and cryoprotectant
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Aktiv komparator: Group C
1 enema of RBX2660 (microbiota suspension) and 1 enema of placebo administered 7 days apart
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A suspension of intestinal microbes
A suspension of saline and cryoprotectant
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Treatment Success of Group A (2 Doses of RBX2660) vs Group B (2 Doses of Placebo) (ITT)
Tidsramme: 8 weeks after last assigned study treatment
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The primary endpoint is to evaluate treatment success, defined as the absence of CDAD without the need for retreatment with C. difficile anti-infective therapy or fecal transplant (FT) at 56 days after administration of the last assigned study enema, of Group A (two enemas of RBX2660) vs. Group B (two enemas of placebo).
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8 weeks after last assigned study treatment
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Treatment Success Between Group C (1 Enema of RBX2660 and 1 Enema of Placebo) vs Group B (Two Enemas of Placebo) (ITT)
Tidsramme: 8-weeks
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Treatment Success was defined as the absence of CDAD without the need for retreatment with C. difficile anti-infective therapy or fecal transplant (FT) at 56 days after administration of the last assigned study enema
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8-weeks
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Treatment Success Evaluated Between Group A (Two Enemas of RBX2660) Versus Group C (1 Enema of RBX2660 and 1 Enema of Placebo) (ITT)
Tidsramme: 8-weeks
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Treatment success, defined as the absence of CDAD without the need for retreatment with C. difficile anti-infective therapy or fecal transplant (FT) at 56 days after administration of the last assigned study enema.
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8-weeks
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SF-36 Scores Obtained at the 1-week, 4-week, and 8-week Assessments Visits During the Double-blind Period as Compared to Baseline (ITT)
Tidsramme: 8-week
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The validated SF-36 scale was used to identify changes to quality of life (QoL) following study treatment.
Each component is analyzed on a norm-based scoring (0-100) with a higher score representing an improvement in QoL.
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8-week
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Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group B (ITT)
Tidsramme: 8-weeks
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Time to CDI Recurrence was evaluated using Kaplan-Meier Analysis and expressed by percentage of subjects who were recurrence free at a certain time point (every 7 days) from completion of the last blinded enema.
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8-weeks
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Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group C vs. Group B (ITT)
Tidsramme: 8-weeks
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Time to CDI Recurrence was evaluated using Kaplan-Meier Analysis and expressed by percentage of subjects who were recurrence free at a certain time point (every 7 days) from completion of the last blinded enema.
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8-weeks
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Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group C (ITT)
Tidsramme: 8-weeks
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Time to CDI Recurrence was evaluated using Kaplan-Meier Analysis and expressed by percentage of subjects who were recurrence free at a certain time point (every 7 days) from completion of the last blinded enema.
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8-weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studiestol: Teena Chopra, MD MPH, Wayne State University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- van Nood E, Vrieze A, Nieuwdorp M, Fuentes S, Zoetendal EG, de Vos WM, Visser CE, Kuijper EJ, Bartelsman JF, Tijssen JG, Speelman P, Dijkgraaf MG, Keller JJ. Duodenal infusion of donor feces for recurrent Clostridium difficile. N Engl J Med. 2013 Jan 31;368(5):407-15. doi: 10.1056/NEJMoa1205037. Epub 2013 Jan 16.
- Gough E, Shaikh H, Manges AR. Systematic review of intestinal microbiota transplantation (fecal bacteriotherapy) for recurrent Clostridium difficile infection. Clin Infect Dis. 2011 Nov;53(10):994-1002. doi: 10.1093/cid/cir632.
- Moayyedi P, Marshall JK, Yuan Y, Hunt R. Canadian Association of Gastroenterology position statement: fecal microbiota transplant therapy. Can J Gastroenterol Hepatol. 2014 Feb;28(2):66-8. doi: 10.1155/2014/346590. No abstract available.
- Kwak S, Choi J, Hink T, Reske KA, Blount K, Jones C, Bost MH, Sun X, Burnham CD, Dubberke ER, Dantas G; CDC Prevention Epicenter Program. Impact of investigational microbiota therapeutic RBX2660 on the gut microbiome and resistome revealed by a placebo-controlled clinical trial. Microbiome. 2020 Aug 31;8(1):125. doi: 10.1186/s40168-020-00907-9.
- Dubberke ER, Lee CH, Orenstein R, Khanna S, Hecht G, Gerding DN. Results From a Randomized, Placebo-Controlled Clinical Trial of a RBX2660-A Microbiota-Based Drug for the Prevention of Recurrent Clostridium difficile Infection. Clin Infect Dis. 2018 Sep 28;67(8):1198-1204. doi: 10.1093/cid/ciy259.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. december 2014
Primær færdiggørelse (Faktiske)
1. januar 2016
Studieafslutning (Faktiske)
1. januar 2018
Datoer for studieregistrering
Først indsendt
19. november 2014
Først indsendt, der opfyldte QC-kriterier
20. november 2014
Først opslået (Skøn)
24. november 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
15. januar 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. december 2020
Sidst verificeret
1. december 2020
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2014-01
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Enterocolitis Clostridium Difficile Tilbagevendende
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Michael E. DeBakey VA Medical CenterBaylor College of MedicineAfsluttetClostridium enterocolitis | Pseudomembranøs colitis | Antibiotika-associeret colitisForenede Stater
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Genzyme, a Sanofi CompanyAfsluttetClostridium Difficile-associeret diarré | Antibiotika-associeret diarré | Clostridium enterocolitis | Clostridium Difficile Diarré | Antibiotika-associeret colitisForenede Stater, Canada, Det Forenede Kongerige, Puerto Rico
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Daniel M. Musher MDBaylor College of MedicineAfsluttetClostridium enterocolitis | Pseudomembranøs colitisForenede Stater
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José María Aguado García, MD, PhDMerck Sharp & Dohme LLC; Hospital Universitario 12 de OctubreAfsluttetEnterocolitis, Pseudomembranøs | Clostridium DifficileSpanien
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Jewish General HospitalAfsluttetFulminant Clostridium Difficile ColitisCanada
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Genzyme, a Sanofi CompanyAfsluttetDiarré | Clostridium enterocolitisAustralien, Belgien, Frankrig, Spanien, Tyskland, Portugal, Schweiz, Østrig, Det Forenede Kongerige, Irland, Tjekkiet, Danmark, Norge, Sverige
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William Beaumont HospitalsAfsluttet
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Massachusetts General HospitalAfsluttetClostridium Difficile ColitisForenede Stater
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Duke UniversityRekrutteringClostridium Difficile ColitisForenede Stater
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William Beaumont HospitalsBeaumont HospitalTrukket tilbageClostridium Difficile ColitisForenede Stater
Kliniske forsøg med RBX2660 (microbiota suspension)
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Rebiotix Inc.AfsluttetOverførbare sygdomme | Infektion | Clostridium Difficile infektionForenede Stater, Canada
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The Second Hospital of Nanjing Medical UniversityAfsluttet
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Rebiotix Inc.AfsluttetClostridium Difficile-infektion (CDI)Forenede Stater, Canada
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Rebiotix Inc.AfsluttetTilbagevendende Clostridium Difficile-infektionForenede Stater
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McMaster Children's HospitalSt. Justine's HospitalAfsluttetInflammatoriske tarmsygdomme | Crohns sygdom | Colitis | Pædiatrisk Crohns sygdomCanada
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University Hospital, GhentResearch Foundation FlandersRekrutteringAfkolonisering af gramnegative multiresistente organismer (MDRO) med donormikrobiota (FMT) (DEKODON)Resistens bakterielBelgien
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International Centre for Diarrhoeal Disease Research...Washington University School of MedicineRekruttering
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Nanfang Hospital of Southern Medical UniversityUkendtSteroid-refraktær gastrointestinal akut graft versus værtssygdomKina
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Amin JaverRekrutteringSinus infektion | Bihulebetændelse, kronisk | Sinus infektion kronisk | Sinus sygdomCanada
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Ferring PharmaceuticalsRekrutteringClostridium Difficile Infektion GentagelseForenede Stater