ASEPTIC: Primary Antibiotic prophylaxis using co-trimoxazole to prevent SpontanEous bacterial PeritoniTIs in Cirrhosis - ASEPTIC

niversity College London Comprehensive Clinical Trials Unit0 个研究点目标入组 548 人开始时间: 2020年4月14日最近更新: 2020年4月20日

适应症

试验速览

暂无简介。

•1.Patients with liver cirrhosis and ascites with ascitic fluid protein count <2.0 g/dL (from sample taken within 12 weeks prior to randomisation)
•2.Patients with ascitic polymorphonuclear count <250 cells/mm3 and negative microbial culture at 5 days (on the last sample sent within 12 weeks prior to randomisation)
•3.Patient at least 18 years of age
•4.Documented informed consent to participate
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 438
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 110

•1.Patients with previous Spontaneous Bacterial Peritonitis (SBP)
•2.Patients receiving palliative care with an expected life expectancy of <8 weeks
•3.Allergic to co-trimoxazole, trimethoprim or sulphonamides
•4.Pregnant or lactating mothers
•5.Patient enrolled in a clinical trial of investigational medicinal products (IMPs) that would impact on their participation in the study
•6.Patients with persistent hyperkalaemia (>6.5 mmol/L) related to pre-existing kidney disease that is not possible to reduce
•7.Patients receiving antibiotic prophylaxis (except for rifaximin)
•8.Patients with long-term ascites drains
•9.Women of child bearing potential and males with a partner of child bearing potential without effective contraception for the duration of trial treatment;
•10.Severe thrombocytopaenia defined as platelets <30 x109/L
•11.Any clinical condition which the investigator considers would make the patient unsuitable for the trial

发起方

niversity College London Comprehensive Clinical Trials Unit