PMID- 26565008
OWN - NLM
STAT- MEDLINE
DCOM- 20161013
LR  - 20220408
IS  - 1537-6591 (Electronic)
IS  - 1058-4838 (Linking)
VI  - 62
IP  - 5
DP  - 2016 Mar 1
TI  - Safety and Durability of RBX2660 (Microbiota Suspension) for Recurrent 
      Clostridium difficile Infection: Results of the PUNCH CD Study.
PG  - 596-602
LID - 10.1093/cid/civ938 [doi]
AB  - BACKGROUND: Managing recurrent Clostridium difficile infection (CDI) presents a 
      significant challenge for clinicians and patients. Fecal microbiota 
      transplantation (FMT) is a highly effective therapy for recurrent CDI, yet 
      availability of a standardized, safe, and effective product has been lacking. Our 
      aim in this study was to assess the safety and effectiveness of RBX2660 
      (microbiota suspension), a commercially prepared FMT drug manufactured using 
      standardized processes and available in a ready-to-use format. METHODS: Patients 
      with at least 2 recurrent CDI episodes or at least 2 severe episodes resulting in 
      hospitalization were enrolled in a prospective, multicenter open-label study of 
      RBX2660 administered via enema. Intensive surveillance for adverse events (AEs) 
      was conducted daily for 7 days following treatment and then at 30 days, 60 days, 
      3 months, and 6 months. The primary objective was product-related AEs. A 
      secondary objective was CDI-associated diarrhea resolution at 8 weeks. RESULTS: 
      Of the 40 patients enrolled at 11 centers in the United States between 15 August 
      2013 and 16 December 2013, 34 received at least 1 dose of RBX2660 and 31 
      completed 6-month follow-up. Overall efficacy was 87.1% (16 with 1 dose and 11 
      with 2 doses). Of 188 reported AEs, diarrhea, flatulence, abdominal 
      pain/cramping, and constipation were most common. The frequency and severity of 
      AEs decreased over time. Twenty serious AEs were reported in 7 patients; none 
      were related to RBX2660 or its administration. CONCLUSIONS: Among patients with 
      recurrent or severe CDI, administration of RBX2660 via enema appears to be safe 
      and effective. CLINICAL TRIALS REGISTRATION: NCT01925417.
CI  - (c) The Author 2015. Published by Oxford University Press for the Infectious 
      Diseases Society of America. All rights reserved. For permissions, e-mail 
      journals.permissions@oup.com.
FAU - Orenstein, Robert
AU  - Orenstein R
AD  - Division of Infectious Diseases, Mayo Clinic-Arizona, Phoenix.
FAU - Dubberke, Erik
AU  - Dubberke E
AD  - Department of Medicine, Washington University School of Medicine, St. Louis, 
      Missouri.
FAU - Hardi, Robert
AU  - Hardi R
AD  - Chevy Chase Clinical Research, Capital Digestive Care, Maryland.
FAU - Ray, Arnab
AU  - Ray A
AD  - Ochsner Clinic, New Orleans, Louisiana.
FAU - Mullane, Kathleen
AU  - Mullane K
AD  - Section of Infectious Diseases and Global Health, University of Chicago Medicine, 
      Illinois.
FAU - Pardi, Darrell S
AU  - Pardi DS
AD  - Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.
FAU - Ramesh, Mayur S
AU  - Ramesh MS
AD  - Henry Ford Hospital System, Detroit, Michigan.
CN  - PUNCH CD Investigators
LA  - eng
SI  - ClinicalTrials.gov/NCT01925417
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20151112
PL  - United States
TA  - Clin Infect Dis
JT  - Clinical infectious diseases : an official publication of the Infectious Diseases 
      Society of America
JID - 9203213
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - *Clostridioides difficile
MH  - Diarrhea/therapy
MH  - Enema
MH  - Enterocolitis, Pseudomembranous/*therapy
MH  - *Fecal Microbiota Transplantation/adverse effects
MH  - Female
MH  - Humans
MH  - Male
MH  - *Microbiota
MH  - Middle Aged
MH  - Prospective Studies
MH  - Recurrence
OTO - NOTNLM
OT  - Clostridium difficile
OT  - fecal microbiota transplant
OT  - microbiome
OT  - safety
FIR - Dubberke, Erik R
IR  - Dubberke ER
FIR - Hardi, Robert
IR  - Hardi R
FIR - Kelly, Ciaran
IR  - Kelly C
FIR - Mariani, Paul
IR  - Mariani P
FIR - Misra, Bharat
IR  - Misra B
FIR - Mullane, Kathleen
IR  - Mullane K
FIR - Orenstein, Robert
IR  - Orenstein R
FIR - Pardi, Darrell S
IR  - Pardi DS
FIR - Price, Connie S
IR  - Price CS
FIR - Ramesh, Mayur S
IR  - Ramesh MS
FIR - Ray, Arnab
IR  - Ray A
FIR - Drekonja, Dimitri
IR  - Drekonja D
EDAT- 2015/11/14 06:00
MHDA- 2016/10/14 06:00
CRDT- 2015/11/14 06:00
PHST- 2015/07/23 00:00 [received]
PHST- 2015/11/04 00:00 [accepted]
PHST- 2015/11/14 06:00 [entrez]
PHST- 2015/11/14 06:00 [pubmed]
PHST- 2016/10/14 06:00 [medline]
AID - civ938 [pii]
AID - 10.1093/cid/civ938 [doi]
PST - ppublish
SO  - Clin Infect Dis. 2016 Mar 1;62(5):596-602. doi: 10.1093/cid/civ938. Epub 2015 Nov 
      12.