EUCTR2019-002677-57-ES进行中（未招募）1 期
A phase III, multicenter, randomized, double-blind clinical trial to evaluate the efficacy and safety of oral vancomycin versus placebo in preventing relapse of Clostridioides difficile infection in patients receiving systemic antibiotic therapy (PREVAN-ICD study). - Estudio PREVAN-ICD
Dra. Julia Origüen Sabater0 个研究点目标入组 108 人开始时间: 2021年6月14日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 108
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
- 性别
- All
入选标准
- •1. Age equal to or greater than 18 years.
- •2. History of infection by Clostrioides difficile (CDI) in the previous 90 days.
- •3. That requires hospital admission and the need to receive systemic antibiotic treatment (at least 1 day of treatment with at least 1 antimicrobial agent during said admission).
- •4. Signature of informed consent.
- •Are the trial subjects under 18? no
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 8
排除标准
- •1. Woman of childbearing age (less than 50 years old, except for those who present a gynecological report proving the presence of menopause) and women who are breastfeeding.
- •2. Allergy to vancomycin
- •3. Impossibility of complying with the study protocol, including the inability to ingest the capsules or to carry out adequate follow-up, including telephone follow-up or the possibility of transfer to the hospital in less than 48 hours if required.
- •4. State of extreme severity or life expectancy of less than 30 days.
- •5. Diagnosis of inflammatory bowel disease or other disease that conditions chronic diarrhea.
- •6. Criteria for diarrhea (3 or more liquid stools in the last 24 hours) or other clinical and / or microbiological data suggesting CDI at the time of selection or in the previous 3 days.
- •7. Antibiotic treatment concomitant or within the previous 5 days with oral vancomycin or other drugs active against C. difficile such as metronidazole, fidaxomicin, tigecycline, fusidic acid, rifaximin or nitazoxanide.
- •8. Have received preventive treatment with oral vancomycin or another active drug against C. difficile in the context of systemic antibiotic therapy in the previous 90 days, including fecal material transplantation.
- •9. That the patient takes more than 72 hours of systemic antibiotic treatment. If at the time of randomization the patient has been on antibiotic treatment for a longer time, the patient will not be eligible for this study.
- •10. Simultaneous participation in another clinical trial using investigational drugs.
- •11. Expected systemic antibiotic therapy time greater than 4 weeks
研究者
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