title: Clearance of Vancomycin-ResistantEnterococcusConcomitant With Administration of a Microbiota-Based Drug Targeted at RecurrentClostridium difficileInfection.
abstract: Background.Vancomycin-resistantEnterococcus(VRE) is a major healthcare-associated pathogen and a well known complication among transplant and immunocompromised patients. We report on stool VRE clearance in a post hoc analysis of the Phase 2 PUNCH CD study assessing a microbiota-based drug for recurrentClostridium difficileinfection (CDI).Methods.A total of 34 patients enrolled in the PUNCH CD study received 1 or 2 doses of RBX2660 (microbiota suspension). Patients were requested to voluntarily submit stool samples at baseline and at 7, 30, and 60 days and 6 months after the last administration of RBX2660. Stool samples were tested for VRE using bile esculin azide agar with 6 µg/mL vancomycin and Gram staining. Vancomycin resistance was confirmed by Etest.Results.VRE status (at least 1 test result) was available for 30 patients. All stool samples for 19 patients (63.3%, mean age 61.7 years, 68% female) tested VRE negative. Eleven patients (36.7%, mean age 75.5 years, 64% female) were VRE positive at the first test (baseline or 7-day follow-up). Of these patients, 72.7%, n = 8 converted to negative as of the last available follow-up (30 or 60 days or 6 months). Of the other 3: 1 died (follow-up data not available); 1 patient remained positive at all follow-ups; 1 patient retested positive at 6 months with negative tests during the interim.Conclusions.Although based on a small sample size, this secondary analysis demonstrated the possibility of successfully converting a high percentage of VRE-positive patients to negative in a recurrent CDI population with RBX2660.
authors.affiliation: Department of Medicine, Washington University School of Medicine, St. Louis, Missouri.
authors.forename: Erik R
authors.initials: ER
authors.lastname: Dubberke
authors.affiliation: Section of Infectious Diseases and Global Health, University of Chicago Medicine.
authors.forename: Kathleen M
authors.initials: KM
authors.lastname: Mullane
authors.affiliation: Department of Medicine, Loyola University Chicago Stritch School of Medicine, Maywood; Edward Hines Jr. Veterans Affairs Hospital, Hines, Illinois.
authors.forename: Dale N
authors.initials: DN
authors.lastname: Gerding
authors.affiliation: Department of Medicine, McMaster University, Hamilton, Ontario.
authors.forename: Christine H
authors.initials: CH
authors.lastname: Lee
authors.affiliation: Departments of Medicine and Microbiology-Immunology and Infectious Diseases, University of Calgary, Alberta, Canada.
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Louie
authors.affiliation: Medical Marketing and Communications, Inc., St. Paul, Minnesota.
authors.forename: Harriet
authors.initials: H
authors.lastname: Guthertz
authors.affiliation: Rebiotix Inc., Roseville, Minnesota.
authors.forename: Courtney
authors.initials: C
authors.lastname: Jones
keywords: Clostridium difficile; RBX2660; VRE; microbiota-based drug; vancomycin-resistant Enterococcus