NCT05369104招募中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.
Pherecydes Pharma1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2022年6月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Clinical control of infection at week 12 visit
研究概览
简要总结
Pilot non comparative study assessing the clinical control of infection of DAIR + SAT +NaCl and DAIR + SAT + Phages anti-Staphylococcus aureus in patients with Staphylococcus aureus Prosthetic Joint Infection with an indication of DAIR + SAT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
All persons will be blinded, except the pharmacist will be unmasking.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥ 18 years
- •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)
- •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
- •Without preoperative diagnosis of superinfection due to another pathogen
- •Phagogram displaying the susceptibility of the strain to at least one of the phages.
- •Patient with a life expectancy of 2 years and more as determined by the principal investigator
- •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) for 1 month after the last study drug administration
- •Females of non-childbearing potential: either surgically sterilized or at least 1 year postmenopausal (amenorrhea duration at least 12 months)
- •Negative pregnancy test
排除标准
- •Early Staphylococcus aureus Prosthesis Joint infection (˂3months after the prosthesis implantation)
- •Other germ found in culture of joint fluid sample
- •Phagogram displaying no susceptibility of the strain to anti-Staphylococcus aureus bacteriophages
- •Patients with ASA score ≥ 4
- •Severe sepsis or Septic shock or hemodynamic instability
- •Patients with an indication to prosthesis replacement or amputation
- •Immunosuppressed patients
- •ALT or AST > 5 x ULN, creatinine > 1.53 mg/dl in men and > 1.24 mg/dl in women
- •Known allergic reactions to components of phages products
- •Medical history which in the opinion of the investigator would mean that the patient is unsuitable for participation in the study
- •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
- •Women/Men refusing to use an effective contraception during 1 month after the last administration of study drug.
研究组 & 干预措施
Control Arm
Placebo Comparator
One local administration of NaCl 0,9% solution is administered at the end of the DAIR procedure.
干预措施: Anti-Staphylococcus aureus Bacteriophages (Biological)
Bacteriophages arm
Experimental
1 mL (PP1493 or PP1815) or 2 mL (PP1493 and PP1815) of suspension of bacteriophages diluted in solution of NaCl 0,9% at the end of DAIR procedure.
干预措施: Anti-Staphylococcus aureus Bacteriophages (Biological)
结局指标
主要结局
Clinical control of infection at week 12 visit
时间窗: week 12 visit
No Fever, no recurrence, no worsening of pain, no periarticular inflammatory and clinical infectious signs, no new surgical request, no Staphylococcus aureus detected in joint fluid.
次要结局
- Adverse Events and Serious Adverse Events(From the time of signing the informed consent form up to study end visit (Months 24))
- Physical examination(From the time of signing the informed consent form up to study end visit (Months 24))
- Clinical laboratory tests(From the time of signing the informed consent form up to study end visit (Months 24))
- Clinical control of infection after Week 12 visit(Month 6, Month 12, Month 18 and Month 24.)
研究者
研究点 (1)
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