Efficacy and safety of intravenous fosfomycin in prosthetic joint infection (PJI) caused by staphylococci, streptococci, enterococci and gram-negative bacilli, including mixed infections and culture negative PJI’s (PROOF-Study”) - PROOF-Study

PRO-IMPLANT Foundation0 个研究点目标入组 226 人2016年12月7日

概览

暂无简介。

注册库

who.int

开始日期

2016年12月7日

结束日期

待定

最后更新

7年前

研究类型

Interventional clinical trial of medicinal product

发起方

•1\. Informed consent has been obtained (prior to planned surgical PJI treatment);
•2\. Subject is \=18 years of age;
•3\. Subject has either a culture negative or a culture positive PJI of the hip, knee or shoulder prosthesis:
•(i) visible purulence of a preoperative aspirate or intraoperative periprosthetic tissue (as determined by the surgeon),or
•(ii) presence of a sinus tract communicating with the prosthesis, or
•(iii) acute inflammation in intraoperative permanent tissue sections by histopathology (as determined by the pathologist), or
•(iv) microbial growth in preoperative joint aspirate, intraoperative periprosthetic tissue or sonication fluid of the removed implant (\>50 CFU/ml sonication fluid), or
•(v) synovial fluid with \>2000 leukocytes/µl or \>70% granulocytes;
•or reasonable evidence for a suspected PJI (based on clinical, laboratory, and radiological criteria) to undergo joint surgery to proof the PJI diagnosis (according to standard of care, Zimmerli W et al. NEJM 2004\);
•4\. For culture positive PJI’s at least one of the following isolates: staphylococci (fosfomycin MHK \= 32 mg/ml), streptococci (MHK \= 128 mg/ml), enterococci (MHK \= 128 mg/ml), fosfomycin susceptible gram\-negative bacilli, including also mixed infections with other pathogens (fosfomycin susceptible or not);

•1\. Allergy or intolerance (or other contraindication) to fosfomycin;
•2\. Isolation of fungi (molds or yeasts) or mycobacteria ;
•3\. Isolation of at least one of the following pathogens: staphylococci MHK \> 32 mg/ml, streptococci MHK \> 128 mg/ml, enterococci MHK \> 128 mg/ml, fosfomycin resistant gram\-negative bacilli;
•4\. Severely compromised bone/soft tissue pre or during surgery (if during surgery: exclusion/withdrawal before IMP application);
•5\. Pregnancy, and/or women wishing to become pregnant;
•6\. Breast\-feeding;
•7\. Women of childbearing potential\* without at least one of the following contraception methods: correctly placed cooper\-containing or progestin\-containing intrauterine device (IUD); female condom used WITH a spermicide (i.e. foam gel, film, cream, or suppository); bilateral tubal ligation/bilateral salpingectomy or bilateral tubal occlusive procedure (at least till the end of the ambulatory treatment phase)\*\*;
•8\. Subject has been previously enrolled in this study or was enrolled in another interventional medicinal product or medical device study in the last 30 days;
•9\. Subject had prior exposure to fosfomycin within the past 4 weeks;
•10\. Inability to read and understand the participant’s information;