Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD2)
23. desember 2020 oppdatert av: 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
150
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
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, Forente stater, 85054
- Mayo Clinic Arizona
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Colorado
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Aurora, Colorado, Forente stater, 80045
- University of Colorado
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Florida
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Jacksonville, Florida, Forente stater, 32256
- Borland-Groover Clinic
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Idaho
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Idaho Falls, Idaho, Forente stater, 83404
- Grand Teton Research Group
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Illinois
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Chicago, Illinois, Forente stater, 60637
- University of Chicago
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Chicago, Illinois, Forente stater, 60153
- Loyola University Chicago
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Indiana
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Indianapolis, Indiana, Forente stater, 46260
- Infectious Diseases of Indiana
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Maryland
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Chevy Chase, Maryland, Forente stater, 20815
- Chevy Chase Clinical Research
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Michigan
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Detroit, Michigan, Forente stater, 48202
- Henry Ford Health System
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Minnesota
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Rochester, Minnesota, Forente stater, 55905
- Mayo Clinic Minnesota
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Saint Paul, Minnesota, Forente stater, 55101
- Regions Hospital
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Missouri
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Saint Louis, Missouri, Forente stater, 63110
- Washington University School of Medicine
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New York
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Flushing, New York, Forente stater, 11355
- New York Hospital Queens
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New York, New York, Forente stater, 10065
- New York-Presbyterian Hospital/Weill Cornell Medical College
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Rochester, New York, Forente stater, 14618
- Gastroenterology Group of Rochester
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North Dakota
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Fargo, North Dakota, Forente stater, 58122
- Sanford Health
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Ohio
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Cleveland, Ohio, Forente stater, 44106
- Louis Stokes Cleveland VA Medical Center
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Lima, Ohio, Forente stater, 45801
- Regional Infectious Diseases and Infusion Center
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19104
- Hospital of the University of Pennsylvania
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studiestol: Teena Chopra, MD MPH, Wayne State University
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. desember 2014
Primær fullføring (Faktiske)
1. januar 2016
Studiet fullført (Faktiske)
1. januar 2018
Datoer for studieregistrering
Først innsendt
19. november 2014
Først innsendt som oppfylte QC-kriteriene
20. november 2014
Først lagt ut (Anslag)
24. november 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
15. januar 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. desember 2020
Sist bekreftet
1. desember 2020
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2014-01
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