ISRCTN65163992已完成未知
A randomised placebo controlled trial of follow on Rifaximin for the prevention of relapse of Clostridium associated diarrhoea
niversity of Nottingham (UK)0 个研究点目标入组 151 人开始时间: 2012年10月26日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 151
研究概览
简要总结
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30254135 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30254135 (added 30/07/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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.
排除标准
- •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.
- •Exclusion criteria from 30/04/2015 to 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
- •* 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.
- •Original exclusion criteria:
- •1. Pregnant or breast feeding
- •2. 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)
- •3. >5 days post standard therapy (metronidazole or vancomycin) for clinically diagnosed CDAD
研究者
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