Cadazolid /ACT-179811 Clostridium Difficile associated diarrhoea(CDAD)
Research type
Research Study
Full title
A multi-center, randomized, double-blind study to compare the efficacy and safety of cadazolid versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD)
IRAS ID
156437
Contact name
Jane Minton
Contact email
Sponsor organisation
Actelion Pharmaceuticals Ltd
Eudract number
2013-002508-15
Clinicaltrials.gov Identifier
Research summary
This study will compare the effect and safety of cadazolid versus vancomycin in subjects with Clostridium difficile-associated diarrhoea (CDAD). CDAD is an infectious disease of the gastrointestinal tract. CDAD usually occurs in patients with a history of antibiotic use that allows toxin-producing C. difficile to grow and cause inflammation of the intestine and diarrhoea. CDAD incidence is increasing and symptoms can vary from occasional diarrhoea to extreme symptoms that can result in surgical removal of all or part of the colon or death.
New therapies are needed that improve the treatment of the disease. Vancomycin has already been proven effective in clinical trials and is approved in many countries for the treatment of CDAD. Cadazolid is a novel antibiotic with activity against C. difficile. High concentrations of cadazolid in the intestine and early clinical studies that have provided promising results make it an attractive candidate for the treatment of CDAD. This study is conducted to show if cadazolid is as effective as or superior to vancomycin as a treatment for CDAD.
After screening to see if patients are suitable, participants who provide written consent and meet all eligibility criteria will receive cadazolid or vancomycin; this will be decided by chance (chances of receiving cadazolid or vancomycin are 1 out of 2 for each treatment). During the treatment period clinic visits and telephone calls will be performed. After the last dose of treatment, there will be a follow up period.
Study procedures include physical examinations, stool and blood tests, ECG (which measures the electrical activity of your heart), and questionnaires.REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
14/YH/1084
Date of REC Opinion
20 Aug 2014
REC opinion
Further Information Favourable Opinion