Comparative effectiveness of intestinal microbiota versus vancomycin for primary Clostridium difficile infection – randomized trials. - COLONIZE

Oslo University Hospital0 个研究点目标入组 188 人开始时间: 2019年1月2日最近更新: 2019年4月30日

适应症

试验速览

暂无简介。

•Patients, =18 years with primary C. difficile infection defined as:
•Diarrhea as defined by the WHO (=3 loose stools per day), and
•Positive stool test for toxin producing C. difficile, and
•No evidence of previous C. difficile infection during 365 days before enrolment.
•Written 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 188
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 188

•Presence of other stool pathogens known to cause diarrhea.
•Ongoing or scheduled (e.g. surgery prophylaxis) antibiotic treatment for other infections that cannot be stopped for 12 hours after treatment allocation.
•Inflammatory bowel disease or microscopic colitis.
•< 3 months life expectancy.
•Serious immunodeficiency, defined as one of the following:
•-Ongoing or recent chemotherapy and current or expected neutropenia with neutrophil count of < 500/µL.
•-Active severe immunocompromising disease.
•Inability to comply with protocol requirements.
•Need of intensive care or American Society of Anesthesiologists (ASA) Physical Status classification IV or V.
•Known irritable bowel syndrome, diarrheal type.
•Pregnancy or nursing.
•Known or suspected toxic megacolon or ileus.
•Total or subtotal colectomy, ileostomy or colonostomy.
•Known hypersensitivity or other contraindications to vancomycin.

发起方

Oslo University Hospital