Evaluation of the efficacy of corticosteroids in septic arthritis in adults: Randomized double-blind controlled trial [CORSAR]
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 20
- 主要终点
- Functional assessment score at week 24. This outcome will be assessed using the total WOMAC score (Western Ontario and McMaster Universities Osteoarthritis Index) for lower limb involvement (hip, knee, or ankle joints). For upper limb involvement (shoulder, elbow, or wrist joints), the QuickDASH score (Disabilities of the Arm, Shoulder and Hand) will be used. The WOMAC or QuickDASH score will be standardized and reported on a scale ranging from 0 to 100 points.
研究概览
简要总结
To evaluate whether corticosteroid administration alongside antibiotic therapy modifies joint prognosis in adult septic arthritis at 24 weeks
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 ≥ 18 years
- •Documented septic arthritis (microorganism identified intra-articularly by culture or PCR, or by turbid synovial fluid with positive Gram stain, or positive blood cultures) - Effective antibiotic therapy initiated within ≤ 3 days
- •Effective antibiotic therapy initiated within ≤ 3 days
- •Signed informed consent
- •Affiliation to a health insurance system
- •Ability to read, write, and understand French
排除标准
- •Polyarticular septic arthritis (≥ 2 joints)
- •Presence of prosthetic joint or osteosynthesis material in the affected joint
- •Septic shock
- •Severe soft tissue wound overlying the affected joint
- •Aplastic chemotherapy
- •Neutropenia (defined as neutrophils < 500/mm³)
- •Mycobacterial infection
- •Fungal infection
- •Sickle cell disease
- •Current pregnancy
- •Breastfeeding women
- •Septic arthritis of small joints (e.g., fingers: PIP, DIP, MCP; toes: MTP)
- •Patients under legal protection (e.g., guardianship)
- •Participation in another interventional drug clinical trial
- •Patient unable to provide informed consent
- •Systemic sclerosis
- •Pyomyositis
- •Diabetic foot infection
- •Current corticosteroid therapy for another indication
- •Inability to take oral medication
- •Contraindication to corticosteroids (notably decompensated diabetes or uncontrolled psychiatric disorders)
- •Associated endocarditis
结局指标
主要结局
Functional assessment score at week 24. This outcome will be assessed using the total WOMAC score (Western Ontario and McMaster Universities Osteoarthritis Index) for lower limb involvement (hip, knee, or ankle joints). For upper limb involvement (shoulder, elbow, or wrist joints), the QuickDASH score (Disabilities of the Arm, Shoulder and Hand) will be used. The WOMAC or QuickDASH score will be standardized and reported on a scale ranging from 0 to 100 points.
Functional assessment score at week 24. This outcome will be assessed using the total WOMAC score (Western Ontario and McMaster Universities Osteoarthritis Index) for lower limb involvement (hip, knee, or ankle joints). For upper limb involvement (shoulder, elbow, or wrist joints), the QuickDASH score (Disabilities of the Arm, Shoulder and Hand) will be used. The WOMAC or QuickDASH score will be standardized and reported on a scale ranging from 0 to 100 points.
次要结局
- Joint flexion and extension measured at weeks 1, 6, and 24 using a goniometer. Presence of flexion contracture (defined as incomplete extension) at 3 months, assessed only for septic arthritis of the hip and knee.
- Any complication assessed by radiological examination of the joint at week 24.
- Number of surgical interventions between randomization and week 24.
- Duration of antibiotic therapy.
- Length of hospital stay
- Pain assessed by Visual Analog Scale (VAS) at weeks 1, 6, and 24.
- Overall mortality.
- Biological inflammatory markers measured at weeks 1, 6, and 24.
- Patient self-assessment of recovery on a 0 to 5 scale (0 = no improvement, 5 = full recovery) at weeks 1, 6, and 24.
- Quality of life assessed by the EQ-5D-5L questionnaire at week 24.
- Number of days on painkillers, overall and according to WHO level (I, II, III), between W1 and W6
- All adverse effects and side effects, particularly glycemic control and neuropsychiatric effects, monitored through patient self-surveillance.
研究者
Dr Benjamin ROSSI
Scientific
Assistance Publique Hopitaux De Paris