Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD2)
23 december 2020 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
150
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Arizona
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Phoenix, Arizona, Förenta staterna, 85054
- Mayo Clinic Arizona
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Colorado
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Aurora, Colorado, Förenta staterna, 80045
- University of Colorado
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Florida
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Jacksonville, Florida, Förenta staterna, 32256
- Borland-Groover Clinic
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Idaho
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Idaho Falls, Idaho, Förenta staterna, 83404
- Grand Teton Research Group
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Illinois
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Chicago, Illinois, Förenta staterna, 60637
- University of Chicago
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Chicago, Illinois, Förenta staterna, 60153
- Loyola University Chicago
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Indiana
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Indianapolis, Indiana, Förenta staterna, 46260
- Infectious Diseases of Indiana
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Maryland
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Chevy Chase, Maryland, Förenta staterna, 20815
- Chevy Chase Clinical Research
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Michigan
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Detroit, Michigan, Förenta staterna, 48202
- Henry Ford Health System
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Minnesota
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Rochester, Minnesota, Förenta staterna, 55905
- Mayo Clinic Minnesota
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Saint Paul, Minnesota, Förenta staterna, 55101
- Regions Hospital
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Missouri
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Saint Louis, Missouri, Förenta staterna, 63110
- Washington University School of Medicine
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New York
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Flushing, New York, Förenta staterna, 11355
- New York Hospital Queens
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New York, New York, Förenta staterna, 10065
- New York-Presbyterian Hospital/Weill Cornell Medical College
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Rochester, New York, Förenta staterna, 14618
- Gastroenterology Group of Rochester
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North Dakota
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Fargo, North Dakota, Förenta staterna, 58122
- Sanford Health
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Ohio
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Cleveland, Ohio, Förenta staterna, 44106
- Louis Stokes Cleveland VA Medical Center
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Lima, Ohio, Förenta staterna, 45801
- Regional Infectious Diseases and Infusion Center
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Pennsylvania
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Philadelphia, Pennsylvania, Förenta staterna, 19104
- Hospital of the University of Pennsylvania
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British Columbia
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Vancouver, British Columbia, Kanada, V5Z 1M9
- University of British Columbia
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Ontario
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Hamilton, Ontario, Kanada, L8N 4A6
- St. Joseph's Hospital
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / 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-jämförare: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Treatment Success of Group A (2 Doses of RBX2660) vs Group B (2 Doses of Placebo) (ITT)
Tidsram: 8 weeks after last assigned study treatment
|
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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Treatment Success Between Group C (1 Enema of RBX2660 and 1 Enema of Placebo) vs Group B (Two Enemas of Placebo) (ITT)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studiestol: Teena Chopra, MD MPH, Wayne State University
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna 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.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 december 2014
Primärt slutförande (Faktisk)
1 januari 2016
Avslutad studie (Faktisk)
1 januari 2018
Studieregistreringsdatum
Först inskickad
19 november 2014
Först inskickad som uppfyllde QC-kriterierna
20 november 2014
Första postat (Uppskatta)
24 november 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
15 januari 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
23 december 2020
Senast verifierad
1 december 2020
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2014-01
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