- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02299570
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD2)
23 décembre 2020 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
150
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V5Z 1M9
- University of British Columbia
-
-
Ontario
-
Hamilton, Ontario, Canada, L8N 4A6
- St. Joseph's Hospital
-
-
-
-
Arizona
-
Phoenix, Arizona, États-Unis, 85054
- Mayo Clinic Arizona
-
-
Colorado
-
Aurora, Colorado, États-Unis, 80045
- University of Colorado
-
-
Florida
-
Jacksonville, Florida, États-Unis, 32256
- Borland-Groover Clinic
-
-
Idaho
-
Idaho Falls, Idaho, États-Unis, 83404
- Grand Teton Research Group
-
-
Illinois
-
Chicago, Illinois, États-Unis, 60637
- University of Chicago
-
Chicago, Illinois, États-Unis, 60153
- Loyola University Chicago
-
-
Indiana
-
Indianapolis, Indiana, États-Unis, 46260
- Infectious Diseases of Indiana
-
-
Maryland
-
Chevy Chase, Maryland, États-Unis, 20815
- Chevy Chase Clinical Research
-
-
Michigan
-
Detroit, Michigan, États-Unis, 48202
- Henry Ford Health System
-
-
Minnesota
-
Rochester, Minnesota, États-Unis, 55905
- Mayo Clinic Minnesota
-
Saint Paul, Minnesota, États-Unis, 55101
- Regions Hospital
-
-
Missouri
-
Saint Louis, Missouri, États-Unis, 63110
- Washington University School of Medicine
-
-
New York
-
Flushing, New York, États-Unis, 11355
- New York Hospital Queens
-
New York, New York, États-Unis, 10065
- New York-Presbyterian Hospital/Weill Cornell Medical College
-
Rochester, New York, États-Unis, 14618
- Gastroenterology Group of Rochester
-
-
North Dakota
-
Fargo, North Dakota, États-Unis, 58122
- Sanford Health
-
-
Ohio
-
Cleveland, Ohio, États-Unis, 44106
- Louis Stokes Cleveland VA Medical Center
-
Lima, Ohio, États-Unis, 45801
- Regional Infectious Diseases and Infusion Center
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, États-Unis, 19104
- Hospital of the University of Pennsylvania
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur actif: Group A
Two enemas of RBX2660 (microbiota suspension) administered 7 days apart
|
A suspension of intestinal microbes
|
Comparateur placebo: Group B
Two enemas of placebo administered 7 days apart
|
A suspension of saline and cryoprotectant
|
Comparateur actif: Group C
1 enema of RBX2660 (microbiota suspension) and 1 enema of placebo administered 7 days apart
|
A suspension of intestinal microbes
A suspension of saline and cryoprotectant
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Treatment Success of Group A (2 Doses of RBX2660) vs Group B (2 Doses of Placebo) (ITT)
Délai: 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).
|
8 weeks after last assigned study treatment
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Treatment Success Between Group C (1 Enema of RBX2660 and 1 Enema of Placebo) vs Group B (Two Enemas of Placebo) (ITT)
Délai: 8-weeks
|
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
|
8-weeks
|
Treatment Success Evaluated Between Group A (Two Enemas of RBX2660) Versus Group C (1 Enema of RBX2660 and 1 Enema of Placebo) (ITT)
Délai: 8-weeks
|
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.
|
8-weeks
|
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)
Délai: 8-week
|
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.
|
8-week
|
Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group B (ITT)
Délai: 8-weeks
|
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.
|
8-weeks
|
Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group C vs. Group B (ITT)
Délai: 8-weeks
|
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.
|
8-weeks
|
Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group C (ITT)
Délai: 8-weeks
|
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.
|
8-weeks
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chaise d'étude: Teena Chopra, MD MPH, Wayne State University
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Liens utiles
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 décembre 2014
Achèvement primaire (Réel)
1 janvier 2016
Achèvement de l'étude (Réel)
1 janvier 2018
Dates d'inscription aux études
Première soumission
19 novembre 2014
Première soumission répondant aux critères de contrôle qualité
20 novembre 2014
Première publication (Estimation)
24 novembre 2014
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
15 janvier 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
23 décembre 2020
Dernière vérification
1 décembre 2020
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies du système digestif
- Processus pathologiques
- Infections
- Attributs de la maladie
- Maladies gastro-intestinales
- Gastro-entérite
- Maladies intestinales
- Infections bactériennes
- Infections bactériennes et mycoses
- Infections bactériennes à Gram positif
- Récurrence
- Entérocolite
- Infections à Clostridium
Autres numéros d'identification d'étude
- 2014-01
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur RBX2660 (microbiota suspension)
-
Rebiotix Inc.ComplétéMaladies transmissibles | Infection | Infection à Clostridium difficileÉtats-Unis, Canada
-
Rebiotix Inc.ComplétéInfection récurrente à Clostridium difficileÉtats-Unis
-
Rebiotix Inc.ComplétéInfection à Clostridium Difficile (ICD)États-Unis, Canada
-
University of MiamiRetiréInfection due à un organisme résistant
-
McMaster Children's HospitalSt. Justine's HospitalComplétéMaladies intestinales inflammatoires | Maladie de Crohn | Colite | Maladie de Crohn pédiatriqueCanada
-
McMaster Children's HospitalLondon Health Sciences Centre; St. Justine's HospitalComplétéRectocolite hémorragique | Maladie inflammatoire de l'intestinCanada
-
Ferring PharmaceuticalsRecrutementRécurrence de l'infection à Clostridium difficileÉtats-Unis
-
Baskent UniversityHacettepe UniversityComplétéUtilisateur de prothèse | Membres artificiels | AmputésTurquie
-
Rebiotix Inc.ComplétéInfection à Clostridium difficileÉtats-Unis, Canada
-
Ferring PharmaceuticalsRecrutement