EUCTR2021-004469-11-ES进行中（未招募）1 期
A Pilot, Multicenter, Randomized, Non Comparative, Double-Blind Study of Phage Therapy in Patients with Hip or Knee Prosthetic Joint Infection due to Staphylococcus aureus Treated with DAIR and Antibiotic Therapy - PhagoDAIR I
PHERECYDES PHARMA0 个研究点目标入组 64 人开始时间: 2022年5月6日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 64
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1.Male or female > or = 18 years
- •2.Staphylococcus aureus monomicrobial knee or hip PJI > 3 months after prosthesis implantation with clinical signs of infection and with indication of DAIR with direct closure and Suppressive Antibiotics Therapy (SAT)
- •3. Staphylococcus aureus only in joint fluid within 6 months before the randomization or in case of relapse of infection under antibiotics therapy after a DAIR performed within 6 months prior to pre-inclusion visit
- •4.Without preoperative diagnosis of superinfection due to another pathogen
- •5.Phagogram displaying the susceptibility of the strain to at least one of the phages.
- •6.Patient with a life expectancy of 2 years and more as determined by the principal investigator
- •7.Females of childbearing potential/Sexually active males with partner of childbearing potential: commitment to consistently and correctly use an acceptable method of birth control (oral, transdermal, systemic or implant contraception birth control, intrauterine devices, diaphragm or condoms) for 1 month after the last study drug administration
- •8.Females of non-childbearing potential: either surgically sterilized or at least 1 year postmenopausal (amenorrhea duration at least 12 months)
- •9.Negative pregnancy test for women with childbearing potential
- •10.Signing a written informed consent before any study related procedyres including phagogramprior to the phagogram
- •11.Affiliated to a national social security system and / or private health insuranceCovered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to biomedical research.
- •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 34
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1. Early Staphylococcus aureus Prosthesis Joint infection ( >3months after the prosthesis implantation)
- •2. Other germ found in culture of joint fluid sample
- •3. Phagogram displaying no susceptibility of the strain to anti-Staphylococcus aureus bacteriophages
- •4. Patients with ASA score > or = 4
- •5. Severe sepsis or Septic shock or hemodynamic instability
- •6. Patients with an indication to prosthesis replacement or amputation
- •7. Immunosuppressed patients
- •8. ALT or AST > 5 x ULN, creatinine > 1.53 mg/dl in men and > 1.24 mg/dl in women
- •9. Known allergic reactions to components of phages products
- •10. Medical history which in the opinion of the investigator would mean that the patient is unsuitable for participation in the study
- •11. Patient who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development
- •12. Currently in exclusion period from a previous study
- •13. Concomitant participation to another interventional clinical trial.
- •14. Patients who are pregnant or breastfeeding. Patients should not be enrolled if they plan to become pregnant during the treatment period and 1 month after the last administration of study drug
- •15. Women/Men refusing to use an effective contraception during 1 month after the last administration of study drug
- •16. No possibility of contact in case of emergency.
- •17. Minors, persons deprived of liberty by judicial or administrative decision, persons receiving psychiatric care and persons admitted to a health or social institution, to adult patient under legal protection or unable to express consent.
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