A randomised placebo controlled trial of follow on Rifaximin for the prevention of relapse of Clostridium associated diarrhoea

niversity of Nottingham (UK)0 sites151 target enrollmentOctober 26, 2012

Overview

Registry

who.int

Start Date

October 26, 2012

End Date

July 14, 2016

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity of Nottingham (UK)

•Current inclusion criteria as of 30/04/2015:
•1\. Men/women aged 18 and over (adults who lack mental capacity for whom there is a legal representative are included)
•2\. Successful treatment of clinically diagnosed CDAD using standard therapy (metronidazole or vancomycin given according to standard local hospital guidelines)
•Previous inclusion criteria:
•1\. Men/women aged 18 and over (adults who lack mental capacity for whom there is a legal representative are included)
•2\. Successful treatment of clinically diagnosed C. difficile\-associated diarrhea (CDAD) using standard therapy (metronidazole or vancomycin given according to standard local hospital guidelines
•3\. Able to swallow tablets
•4\. Able to stop chronic antibiotic use
•5\. Women of child bearing potential willing and able to use at least one highly effective contraceptive method throughout the study. Acceptable contraceptive methods include: established use of oral, injected or implanted hormonal methods; placement of an intrauterine device (IUD) or intrauterine system (IUS); condom or occlusive cap (diaphragm or cervical/vault caps) with spermicide; true abstinence (when this is in line with the preferred and usual lifestyle of the participant); or vasectomised partner.

•Current exclusion criteria as of 24/02/2016:
•1\. Woman of childbearing potential and not willing to use at least one highly effective contraceptive method throughout the study\*
•2\. Male with spouse/partner of childbearing potential and not willing to use condoms
•3\. Pregnant or breastfeeding
•4\. Unable to swallow tablets
•5\. Life expectancy of \<4 weeks
•6\. Hypersensitivity to the active substance, to any rifamycin (e.g. rifampicin or rifabutin) or to any of its excipients (tablet core: sodium starch glycolate type A, glycerol distearate, colloidal anhydrous, silica, talc and microcrystalline cellulose. Tablet coating: hypromellose, titanium dioxide (E171\), disodium edentate, propylene glycol and red iron oxide E172\)
•7\. \>5 days post standard therapy (metronidazole or vancomycin) for clinically diagnosed CDAD
•8\. Taking ciclosporin
•\* Acceptable contraceptive methods include: established use of oral, injected or implanted hormonal methods; placement of an intrauterine device (IUD) or intrauterine system (IUS); condom or occlusive cap (diaphragm or cervical/vault caps) with spermicide; true abstinence (when this is in line with the preferred and usual lifestyle of the participant); or vasectomised partner.