title: Surotomycin versus vancomycin for Clostridium difficile infection: Phase 2, randomized, controlled, double-blind, non-inferiority, multicentre trial.
abstract: Clostridium difficile infection (CDI) is a major public health concern. Treatment with commonly prescribed antibiotics is associated with high rates of recurrence after initial cure. Here, we present the efficacy and safety of surotomycin, an orally administered, minimally absorbed, selective bactericidal cyclic lipopeptide, compared with vancomycin, in patients with CDI.
  
  
  
  In this Phase 2, randomized, controlled, double-blind, non-inferiority, multicentre trial, participants received surotomycin 125 mg twice daily, surotomycin 250 mg twice daily or vancomycin 125 mg four times daily for 10 days. The primary efficacy outcome was clinical response at end of treatment. The registration number of the study on clinicaltrials.gov is NCT01085591.
  
  
  
  Clinical cure rates were similar among treatment groups (92.4% for surotomycin 125 mg twice daily, 86.6% for surotomycin 250 mg twice daily and 89.4% for vancomycin). Recurrence rates were 27.9% for surotomycin 125 mg twice daily, 17.2% for surotomycin 250 mg twice daily and 35.6% for vancomycin. The lower recurrence rate with surotomycin 250 mg twice daily versus vancomycin was statistically significant (P = 0.035). Recurrence rates were statistically similar between the surotomycin dose groups (P = 0.193). Rates of sustained clinical response at end of study were 66.7% for surotomycin 125 mg twice daily, 70.1% for surotomycin 250 mg twice daily and 56.1% for vancomycin. Incidence of adverse events was similar among treatment arms.
  
  
  
  Recurrence rates of CDI were lower with surotomycin with higher sustained clinical response rates compared with vancomycin, both of which may offer potential clinical benefits.
authors.affiliation: St. Joseph's Healthcare, Hamilton Regional Laboratory Medicine Program, McMaster University, 50 Charlton Avenue East, Hamilton, Ontario L8N 4A6, Canada Island Health Authority, Royal Jubilee Hospital, 1952 Bay St, Victoria BC V8R 1J8, Canada clee@mcmaster.ca.
authors.forename: Christine H
authors.initials: CH
authors.lastname: Lee
authors.affiliation: Merck and Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA.
authors.forename: Hernando
authors.initials: H
authors.lastname: Patino
authors.affiliation: Gastroenterology Consultant, 55 Huntington Rd, Newton, MA 02458, USA.
authors.forename: Chris
authors.initials: C
authors.lastname: Stevens
authors.affiliation: Merck and Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA.
authors.forename: Shruta
authors.initials: S
authors.lastname: Rege
authors.affiliation: Merck and Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA.
authors.forename: Laurent
authors.initials: L
authors.lastname: Chesnel
authors.affiliation: University of Calgary, Foothills Medical Centre, 1403 29th Street NW, Calgary, Alberta T2N 2T9, Canada.
authors.forename: Thomas
authors.initials: T
authors.lastname: Louie
authors.affiliation: The University of Chicago Department of Medicine, 5841 S. Maryland Avenue, Chicago, IL 60637, USA.
authors.forename: Kathleen M
authors.initials: KM
authors.lastname: Mullane
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016360:Clostridioides difficile / Q000187:drug effects*; D003015:Clostridium Infections / Q000188:drug therapy* / Q000382:microbiology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D055666:Lipopeptides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010456:Peptides, Cyclic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012008:Recurrence; D016896:Treatment Outcome; D014640:Vancomycin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000900:Anti-Bacterial Agents; C574454:CB-183,315; D055666:Lipopeptides; D010456:Peptides, Cyclic; D014640:Vancomycin