2025-524744-36-00招募中2 期
DOXYCYCLINE PENETRATION INTO BONE AND JOINT.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To measure doxycycline penetration in cancellous bone using the cancellous bone concentration/plasmatic concentration ratio
研究概览
简要总结
The objective of this study is to provide robust data on bone penetration of the doxycycline in non-infected patient. The primary objective is to determine the penetration of doxycycline in cancellous bone.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 80 years old.
- •Scheduled for elective surgery for hip replacement due to coxarthrosis
- •Signed informed consent
- •Patients eligible for French social insurance
- •Participants able to fully understand the study and who accept its requirements and constraints
排除标准
- •Patients with contraindications to doxycycline ( hypersensitivity to the active substance or to any of the excipients (particularly as generic formulations are authorized in the study and excipients may therefore differ), hypersensitivity to tetracycline-class antibiotics, co-administration of retinoids, or vitamin A supplementation exceeding 10,000 IU/day, due to the risk of intracranial hypertension and intestinal obstruction).
- •Patient with a contraindication to surgical procedure
- •history of osteoarticular infection related to hip prosthesis surgery
- •Patient who has received antibiotics within one month prior to the procedure
- •Patient who did not take Doxycycline as planned in the protocol.
- •Patient being a relative of the investigator or any member of the team directly involved in the study, including assistant physicians, pharmacists, nurses, and coordinators.
- •malabsorption syndrome or conditions likely to impair antibiotic absorption (sleevs, colectomy, gastrointestinal antacids (magnesium, aluminum, or calcium salts, oxides, or hydroxides) and oral iron salts……)
- •Malnutrition patient (BMI < 21 kg/m2) or with serum albumin < 30g/L
- •Kidney failure with GFR < 60 mL/min/1,73m2
- •Patients unable to take oral doxycycline
- •Pregnant or breastfeeding women
- •Women of childbearing age without effective contraception : childbearing age means non menopausal women. Effective contraception includes taking a contraceptive pill or using an Intra Uterine Device.
- •Patients under guardianship, curatorship, legal protection or conservatorship
- •Patient with an infection at the time of surgical management
结局指标
主要结局
To measure doxycycline penetration in cancellous bone using the cancellous bone concentration/plasmatic concentration ratio
To measure doxycycline penetration in cancellous bone using the cancellous bone concentration/plasmatic concentration ratio
次要结局
- To mesure the concentration of Doxycycline in cortical bone using the cortical bone concentration/plasmatic concentration ratio
- To measure the concentration of Doxycycline in synovial fluid using the synovial fluid concentration/plasmatic concentration ratio
研究者
Investigateur coordinateur
Scientific
Centre Hospitalier Universitaire De Caen Normandie
研究点 (1)
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