EUCTR2016-002673-35-DE进行中（未招募）1 期
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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 226
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •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);
- •5. Subject is planned to/will undergo appropriate surgical procedure following the state of the art PJI treatment algorithm, which includes either debridement & retention of the prosthesis or exchange of the prosthesis. The exchange includes a one-stage exchange, two-stage prosthesis exchange with a short interval (2-3 weeks) or long interval (6-8 weeks), according to the treatment algorithm;
- •6. Subject is willing to participate in the study, follow protocol study treatment regimen, and comply with all planned follow-up assessments.
- •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 46
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 180
排除标准
- •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;
- •11. Subjects institutionalized by warrant or court order;
- •12. Employees of the sponsor or an involved CRO;
- •13. In pre surgery culture negative patients: All isolates unsusceptible to fosfomycin after surgery (exclusion / early withdrawal after surgery);
- •14. Suspected PJI not proven after surgery (exclusion / early withdrawal after surgery).
研究者
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