Active-Controlled Study of CB-183,315 in Patients with CDAD
Research type
Research Study
Full title
A Randomized, Double-Blinded, Active-Controlled Study of CB-183,315 in Patients with Clostridium Difficile Associated Diarrhea
IRAS ID
107767
Contact name
David Dockrell
Sponsor organisation
Cubist Pharmaceuticals, Inc.
Eudract number
2012-000252-34
Clinicaltrials.gov Identifier
Research summary
This is a medical research study designed to look at the safety and efficacy of an oral dose of CB 183,315 and oral vancomycin against CDAD (Clostridium difficile Associated Diarrhea). CDAD is a condition caused by the inflammation of the toxin produced by a bacteria called C. difficle. The infection generally results when the normal flora (microorganisms) of the colon is substantially altered by antibiotic treatment. The decrease in this normal flora allows for the growth of the C. difficile bacteria. CB-183,315 is an investigational drug that has been shown to have activity against this type of infection in animal and in vitro (in an artificial environment outside a living organism or body) studies. In addition to these studies, CB-183,315 has also been tested in two studies of human healthy volunteers and one study with patients who had CDAD. The Food and Drug Administration (FDA) CB-183,315 has not approved CB-183,315 for use in humans, therefore its use in this study is investigational. Oral vancomycin is an approved antibiotic that is commonly used to treat CDAD.
REC name
HSC REC A
REC reference
12/NI/0129
Date of REC Opinion
27 Sep 2012
REC opinion
Further Information Favourable Opinion