A ß-d-glucan guided antifungal stewardship strategy for the management of patients with severe abdominal sepsis. A multicenter interventional explorative study with a pharmadynamic/pharmachokinetic substudy entitled: A Pilot substudy of Liposomal Amphotericin B Pharmacodynamics in Patients with Abdominal Sepsis” conducted only in the coordinating center - LAMBDA

AOU DI BOLOGNA POLICLINICO S.ORSOLA-MALPIGHI0 个研究点目标入组 40 人开始时间: 2020年11月4日最近更新: 2021年1月5日

适应症

试验速览

暂无简介。

•Inclusion criteria
•1.All adult (= 18 years) patients
•2.Patients with a severe surgical abdominal disease (SAD) defined as post-operative peritonitis, recurrent gastrointestinal perforation, post-operative hepatobiliary and pancreatic disorders, intra-abdominal abscess and anastomotic leak
•3.Patients with severe sepsis or septic shock;
•4.Signed 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 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•Exclusion criteria
•1.Patients with documented history of hypersensitivity or allergic reaction to liposomial amphotericin B
•2.Pregnancy, lactation or patients at risk for pregnancy: premenopausal or postmenopausal woman within 12 months of last menses without negative pregnancy test or not committing to adequate birth control (e.g., oral contraceptive, two methods of barrier birth control). Diagnosis of pregnancy will be done using quantitative blood ß-HCG test.
•3.Neutropenia > grade 2 defined as absolute neutrophils count = 1000/mmc
•4.Concomitant treatment with cyclosporine, aminoglycosides and pentamidine

发起方

AOU DI BOLOGNA POLICLINICO S.ORSOLA-MALPIGHI