NL-OMON53569尚未招募2 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
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 16
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
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Male or female >= 18 years
- •2. Staphylococcus aureus monomicrobial knee or hip PJI *1 month after
- •prosthesis implantation with clinical signs of infection and with indication of
- •DAIR with direct closure (if associated flap, arthrotomy must be sealed), and
- •Suppressive Antibiotics Therapy (SAT)
- •3. Staphylococcus aureus only in joint fluid within 6 months before
- •randomization or in case of relapse of infection under antibiotics therapy
- •after a DAIR performed within 6 months before pre-inclusion visit
- •4. Without preoperative diagnosis of superinfection due to another pathogen if
- •treatment is administered at the end of the DAIR
- •5. Without diagnosis of superinfection due to another pathogen identified
- •within 72h after a bacteriological sample performed during a DAIR if treatment
- •is administered 14±2 days after a DAIR.
- •6. Phagogram displaying the susceptibility of the strain to at least one of the
- •7. Patient with a life expectancy of 2 years and more as determined by the
- •principal investigator
- •8. Females of childbearing potential/Sexually active males with partner of
- •childbearing potential: commitment to consistently and correctly use an
- •acceptable effective method of birth control (oral, transdermal, systemic or
- •implant contraception birth control, intrauterine devices, condom) for 1 month
- •after the last study drug administration
- •9. Females of non-childbearing potential: either surgically sterilized or at
- •least 1 year postmenopausal (amenorrhea duration at least 12 months)
- •10. Negative pregnancy test
- •11. Signing a written informed consent before any study related procedures
- •including phagogram
- •12. Affiliated to a national social security system and / or private health
- •insurance in compliance with the
排除标准
- •1. Early Staphylococcus aureus Prosthesis Joint infection (*1month 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 >= 4
- •5. Severe sepsis or Septic shock or hemodynamic instability
- •6. Patients with an indication to prosthesis replacement or amputation
- •7. Immunosuppressed patients
- •8. Known allergic reactions to components of phages products
- •9. Relapse between DAIR and treatment administration planned 14±2 days after a
- •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 or
- •previous participation with active drug levels still present, i.e. the last
- •medication intake is less than 4 half-lives ago
- •14. Patients who are pregnant or breastfeeding. Patients should not be enrolled
- •if they plan to become pregnant during the treatment period and up to 1 month
- •after the last administration of study drug
- •15. Women/Men refusing to use an acceptable 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
研究者
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