Protocol AC-061A201 Clostridium difficile infection Version 1

• Research type

  Research Study

• Full title

  A multi-center, double-blind, randomized, active reference, parallel group study to evaluate the efficacy, safety and tolerability of a 10 day twice daily oral administration of 3 doses of ACT-179811 in subjects with Clostridium difficile infection (CDI)

• IRAS ID

  61084

• Contact name

  Simon Smale

• Eudract number

  2010-020941-29

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This is a Phase 2 dose finding study with the new drug ACT-179811 in patients with clostridium difficile infection. The study will look at whether a 10 day treatment course will cure the C. Difficile infection. A comparator drug, Vancomycin will be used as a reference drug. The study will be conducted in a maximum of 20 centers in up to 8 European and North American countries. This study is for Male or Female subjects 18 years or older. The study is funded by Actelion Pharmaceuticals Ltd. Clostridium difficile infection is a growing problem around the world and current antibiotic therapies still have their limitations such as a high recurrence rate. It is hoped that newer treatments such as ACT-179811 will provide an effective cure and reduce the level of disease recurrence. The study will be conducted in a hospital setting and will last approximately 9 months. Individual patients will take the medication for 10 days but they will be followed up for up to 41 days in total. They will undergo some standard safety and efficacy testing (blood tests, ECGs, temperature and vital signs). In particular patients will have their faeces tested regularly to see if the therapy has cured the infection.

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  10/H0405/85

• Date of REC Opinion

  8 Nov 2010

• REC opinion

  Further Information Favourable Opinion