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: 2018年6月5日

适应症

试验速览

暂无简介。

•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

•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.

发起方

Emilio Bouza Santiago