EUCTR2017-003147-38-ES进行中（未招募）1 期
Open, randomized clinical trial to evaluate the treatment of First Clostridium difficile infection episodes with bacteriotherapy
Emilio Bouza Santiago0 个研究点目标入组 70 人开始时间: 2017年10月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
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
- •Men and women
- •Age> 18 years
- •That they agree and are able to give their informed consent (patient or legal representative).
- •Microbiological Diagnosis of toxigenic Clostridium difficile (ICD) infection with direct positive toxin test and diarrhea (> 3 bowel movements / 24 hours) or colonoscopic or histopathological findings that demonstrate pseudomembranous colitis within the first 72 hours before receiving the first dose of treatment.
- •Patients who are in a first episode of ICD that meet criteria of risk of poor outcome.
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •Intensive care unit admission
- •Pregnant or breatsfeeding patients at the signing of consent.
- •Patients with neutropenia (with a total neutrophil count <0.5 x 109 / L)
- •Enteritis by Salmonella, Shigella, E. coli 0157H7, Yersinia or Campylobacter.
- •Severe baseline disease whose expected survival is less than three months.
- •Patients with Child C cirrhosis
- •Patients with current or recent (<3 months) treatment with antineoplastic agents or immunosuppressive medication (including but not limited to monoclonal antibodies to B and T cells, anti-TNF agents, antimetabolites (azathioprine, 6-mercaptopurine), inhibitors of calcineurin (tacrolimus, cyclosporine) mycophenolate mofetil.
- •Patients with a history of severe allergy (anaphylactic) to food.
- •Patients with known allergy or hypersensitivity to vancomycin or fidaxomicin.
- •Patients with fever on the day planned for bacteriotherapy
- •Gastroparesis
- •known Chronic aspiration
- •Dysfunction when swallowing or not oral-motor coordination
- •Patients with any condition, which in the opinion of their physician, bacteriotherapy may endanger the health of the patient.
- •Administration of any investigational antibiotic drug during the 30 days prior to inclusion in the study.
研究者
相似试验
尚未招募
2 期
A Study to evaluate the therapeutic effectiveness of selective Siddha Medicines – VeBSaM Therapy in the management of CholelithiasisCTRI/2024/06/069131ational Institute of Siddha
尚未招募
2 期
A Study on siddha medicine (karunjeeeraga chooranam and silasathu parpa mathirai) for Hyperlipidemia among outpatients attending ayothidoss pandithar hospitalCTRI/2024/06/069396ational Institute Of Siddha
进行中（未招募）
1 期
Prospective and open clinical trial to evaluate the rapidity of action of a 0.005% estriol vaginal gel on the signs and symptoms of vaginal atrophy in postmenopausal women. BLISSET StudyGenitourinary syndrome of menopause (GSM)MedDRA version: 20.0 Level: PT Classification code 10051775 Term: Postmenopause System Organ Class: 10041244 - Social circumstancesEUCTR2019-001435-31-ESITF Research Pharma S.L.U.40
尚未招募
Unknown
To study the effectiveness of Varmam manipulation technique with Murivu Ennai (External medicine) for the management of Anterior Cruciate Ligament InjuryCTRI/2024/06/068801ational Institute of Siddha
招募中
2 期
Clinical Research of siddha medicine Amukkara chooranam(internal medicine) and Milagu mezhugu(external medicine)for the management of Taenia infections.CTRI/2018/05/014301ational institute of Siddha