EUCTR2006-004291-12-FR进行中（未招募）1 期
A MULTI-NATIONAL, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY TO COMPARE THE SAFETY AND EFFICACY OF 200 mg PAR-101 TAKEN q12h WITH 125 mg VANCOMYCIN TAKEN q6h FOR TEN DAYS IN SUBJECTS WITH CLOSTRIDIUM DIFFICILE-ASSOCIATED DIARRHEA
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 664
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1.Male or female in/outpatients 16 years of age or older who have CDAD as defined by
- •-Diarrhoea:is defined as a change in bowel habits, with >3 unformed bowel movements in the 24 hours prior to randomisation, and
- •-Presence of either toxin A or B of C. difficile in the stool.
- •2.Female subjects of childbearing potential must be using an adequate and reliable method of contraception (eg. barrier with additional spermicide foam or jelly, intrauterine device, hormonal contraception). Females who are postmenopausal must have been postmenopausal at least 1 year. Subjects (both male and female) must agree to avoid conception during treatment and for four weeks following the end of study treatment.
- •3. All subjects will be required to sign an Informed Consent Form.
- •4. Opiates will be permitted as long as the subject is on a stable dose at the time of
- •randomization and is expected to maintain this dose during the treatment period.
- •PRN opiate is permitted as long as the total daily dose is not changed during the
- •treatment period.
- •5. Subjects who have failed at least a full 3-day course of metronidazole but continue to meet the definition of diarrhea without any significant clinical improvement and remain toxin positive may be enrolled in the study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Life threatening or fulminant CDAD (WBC>30x109/L; temperature >40C; or evidence of hypotension [systolic blood pressure less than 90 mm Hg], and septic shock, peritoneal signs or significant dehydration.)
- •2. Toxic megacolon.
- •3. Previous exposure to PAR-101/OPT-80.
- •4. Females who are pregnant or breastfeeding.
- •5.Likelihood of death within 72 hours from any cause.
- •6. Concurrent use of: oral vancomycin, metronidazole, oral bacitracin, fusidic acid, rifaximin, nitazoxanide, or related drugs. If the Investigator feels the clinical imperative to begin treatment before knowing the laboratory result for stool toxin, up to 4 doses but no more than 24 hours of treatment with metronidazole and/or vancomycin will be allowed. While such pretreated subjects may be enrolled (ie. no more than 24 hours of previous therapy), it is preferred that subjects be enrolled who have not received prior CDAD treatment on this admission. The Investigators are encoursaged to identify eligible subjects whenever possible before other therapy is given and to sensitise their institution to this study so that subjects may be entered without prior therapy whenever possible.
- •7. The anticipated need to continue other antibacterials for a period exceeding seven days from study start.
- •8. Subjects who in the opinion of the investigator require other drugs to control diarrhea (e.g., loperamide) or which could affect peristalsis.
- •9. Unable or unwilling to compy with study protocol, including ingesting capsules, having blood drawn, and providing stool samples as scheduled.
- •10. Participation in other clinical research studies utilising an investigational agent within one month prior to screening or within five half lives of the investigational agent, whichever is longer.
- •11. History of ulcerative colitis or Crohn's disease.
- •12. Multiple occurrences (defined as more than one prior occurence) of CDAD within the past three months. Subjects presenting with the first recurrence within the three months may be enrolled.
- •13. Subjects the Investigator feels are inappropriate for the trial will not be included, eg. subjects with known hypersensitivity to vancomycin.
研究者
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