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Fecal Microbiota Transplantation via Colonoscopy for Recurrent C. difficile Infection
Published on: December 8, 2014
Clearance of Vancomycin-Resistant Enterococcus Concomitant With Administration of a Microbiota-Based Drug Targeted at
Erik R Dubberke1, Kathleen M Mullane2, Dale N Gerding3
1Department of Medicine, Washington University School of Medicine, St. Louis, Missouri.
Abstract:
Vancomycin-resistant Enterococcus (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 recurrent Clostridium difficile infection (CDI). 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. 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. 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.
Insights
This study explored vancomycin-resistant Enterococcus (VRE) clearance in patients receiving a microbiota-based drug for recurrent Clostridium difficile infection (CDI). A significant percentage of VRE-positive patients achieved VRE-negative status after treatment.
Area of Science:
- Microbiology and Infectious Diseases
- Gastroenterology
- Clinical Research
Background:
- Vancomycin-resistant Enterococcus (VRE) is a significant healthcare-associated pathogen.
- VRE poses a particular risk to transplant recipients and immunocompromised individuals.
- Recurrent Clostridium difficile infection (CDI) is a common complication in vulnerable patient populations.
Purpose of the Study:
- To conduct a post hoc analysis of the PUNCH CD study.
- To assess vancomycin-resistant Enterococcus (VRE) stool clearance.
- To evaluate the efficacy of RBX2660, a microbiota-based therapeutic, in patients with recurrent Clostridium difficile infection (CDI).
Main Methods:
- 34 patients with recurrent CDI received 1-2 doses of RBX2660.
- Voluntary stool samples were collected at baseline and multiple follow-up points (7, 30, 60 days, 6 months).
- VRE detection utilized bile esculin azide agar with vancomycin and Gram staining, with confirmation by Etest.
Main Results:
- Of 30 patients with available VRE status, 19 (63.3%) were initially VRE-negative.
- Eleven patients (36.7%) were initially VRE-positive; 8 (72.7%) converted to VRE-negative status by the last follow-up.
- One VRE-positive patient died, one remained persistently positive, and one had a late positive retest.
Conclusions:
- RBX2660 demonstrated potential for achieving vancomycin-resistant Enterococcus (VRE) clearance in a recurrent Clostridium difficile infection (CDI) patient cohort.
- Despite the small sample size, the results suggest a possible therapeutic benefit for VRE-positive patients treated with this microbiota-based drug.
- Further investigation is warranted to confirm these findings in larger, prospective studies.
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