SMT19969/C003

• Research type

  Research Study

• Full title

  A Phase II, Randomized, Open-Label, Active-Controlled Clinical Study to Investigate the Safety and Efficacy of SMT19969 (200 mg BID) for 10 days Compared with Fidaxomicin (200 mg BID) for 10 days for the Treatment of Clostridium difficile Infection (CDI)

• IRAS ID

  160707

• Contact name

  Ian Foley

• Contact email

  ian.foley@summitplc.com

• Sponsor organisation

  Summit Corporation plc

• Eudract number

  2013-005483-25

• Duration of Study in the UK

  1 years, 3 months, days

• Research summary

  A Clostridium difficile infection (CDI) is a type of bacterial infection that can affect the digestive system. It occurs most commonly in people who have been treated with antibiotics. The symptoms can range from mild to severe and include diarrohea, cramps and a high temperature. A CDI infection can also lead to life-threatening complications like severe swelling of the bowel from a buildup of gas (toxic megacolon).
  The current antibiotic treatment options for CDI are limited and include vancomycin, metronidazole or a new antibiotic fidaxomicin. These antibiotics can cure initial infection but the infection can often return which is called recurrent disease. Fidaxomicin shows an overall improvement over vancomycin, however even with fidaxomicin approximately 30% of patients failed to show a sustained clinical response which means either the initial therapy failed to treat the infection or they had recurrent disease. Therefore there is a significant unmet medical need for a CDI therapy that is effective at both treating initial infection and reducing rates of recurrent disease.
  Summit plc. have developed SMT19969, a novel, narrow spectrum (targets C. difficile more specifically) antimicrobial developed for the treatment of CDI with the goal to also reduce rates of recurrent disease.
  Approximately 30 participants with a confirmed diagnosis of CDI will be randomised (treated equally) between each of the treatment groups:
  • SMT19969 200mg administered orally twice a day for 10 days or
  • Fidaxomicin 200mg administered orally twice a day for 10 days

  This is a phase II randomised open label active controlled study which means that the participants and doctors will be aware of which treatment they will be receiving and all participants will receive an active treatment. There will be no placebo (drug has no medical effect) in this study. This is a multicentre study that will take place at 3 study sites within the United Kingdom.
  

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  14/WM/1143

• Date of REC Opinion

  8 Oct 2014

• REC opinion

  Further Information Favourable Opinion