Evaluation of the Efficacy of Corticosteroids in Septic Arthritis in Adults

Официальное название

Evaluation of the Efficacy of Corticosteroids in Septic Arthritis in Adults: Randomized Double-blind Controlled Trial

Обзор

Septic arthritis is a severe infection associated with significant morbidity and mortality. Despite eradication of the microorganisms, persistent inflammation may lead to substantial long-term functional joint sequelae. The use of corticosteroids could reduce this inflammation, thereby improving functional joint outcomes and facilitating first-line medical treatment. The hypothesis of this study is that corticosteroid administration, in addition to antibiotic therapy, reduces persistent inflammation and improves functional joint prognosis in adult patients with acute septic arthritis.

Подробное описание

Septic arthritis is a severe infection with a mortality rate of 10-15% and morbidity up to 25% due to rapid joint destruction. Despite antibiotic treatment, persistent intra-articular inflammation increases the risk of long-term joint damage. Standard care includes antibiotics and joint drainage, either surgically (arthrotomy or arthroscopy) or by repeated bedside aspiration. Surgery carries risks of nosocomial infections and complications, and aspirations are not always feasible.

Corticosteroids are currently not recommended in adult septic arthritis due to concerns that their anti-inflammatory effects might worsen infection. However, corticosteroids have shown benefits in other infections, improving outcomes in meningitis and pneumonia. Animal studies suggest that host inflammatory responses, particularly activation of CD4+ lymphocytes and macrophages, drive joint damage, and corticosteroids reduce this inflammation, preserving cartilage.

In children with septic arthritis, corticosteroids have been shown to reduce long-term joint damage, symptom duration, and hospital stay without increasing infection risk. To date, no randomized controlled trials have evaluated corticosteroids in adult septic arthritis.

This study aims to assess the efficacy and safety of adjunctive corticosteroid therapy with antibiotics in adults with septic arthritis, focusing on reducing joint sequelae, pain, hospital stay, and surgical interventions.

Вмешательства

• Препарат oral prednisone or placebo at a dose of 60 mg per day for 7 days
  oral prednisone or placebo at a dose of 60 mg per day for 7 days

Первичные конечные точки

• To assess the effect of adjunctive corticosteroid therapy added to standard antibiotic treatment on functional joint outcomes at 24 weeks in adult patients with acute septic arthritis. [Срок оценки: 24 weeks]
• To assess the effect of adjunctive corticosteroid therapy added to standard antibiotic treatment on functional joint outcomes at 24 weeks in adult patients with acute septic arthritis. [Срок оценки: 24 weeks]

Вторичные конечные точки (11)

• To evaluate the effect of corticosteroids on joint range of motion. [Срок оценки: 1, 6, and 24 weeks]
• To assess joint-related complications. [Срок оценки: 24 weeks]
• To determine whether corticosteroid administration affects the need for surgical intervention. [Срок оценки: 24 weeks]
• To evaluate whether corticosteroids modify the duration of antibiotic therapy. [Срок оценки: 24 weeks]
• To assess the impact of corticosteroids on length of hospital stay. [Срок оценки: 24 weeks]
• To evaluate the effect of corticosteroids on pain. [Срок оценки: 24 weeks]
• To assess the effect of corticosteroids on overall mortality. [Срок оценки: 24 weeks]
• To evaluate the impact of corticosteroids on systemic inflammation. [Срок оценки: 24 weeks]
• To assess the effect of corticosteroids on patient-reported recovery. [Срок оценки: 24 weeks]
• To evaluate the impact of corticosteroids on quality of life. [Срок оценки: 24 weeks]
• To assess corticosteroid tolerance, including glycemic control and neuropsychiatric effects. [Срок оценки: 24 weeks]

Критерии участия

Критерии включения

• 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 contraception for women of childbearing age during treatment period
• Signed informed consent
• Affiliation to the French national health insurance system
• Ability to read, write, and understand French

Критерии исключения

• Polyarticular septic arthritis (≥ 2 joints)
• Septic arthritis of small joints (e.g., fingers: proximal interphalangeal joint (PIP), distal interphalangeal joints (DIP), MetaCarpoPhalangeal (MCP); toes: MTP)
• Systemic sclerosis
• Pyomyositis
• Diabetic foot infection
• Current corticosteroid therapy for another indication
• Inability to take oral medication
• Contraindication to corticosteroids
• Associated endocarditis
• Presence of prosthetic joint or osteosynthesis material in the affected joint
• Septic shock
• Severe soft tissue wound overlying the joint
• Aplastic chemotherapy
• Neutropenia (defined as neutrophils < 500/mm³)
• Mycobacterial infection
• Fungal infection
• Sickle cell disease
• Current pregnancy
• Breastfeeding women
• Patients under legal protection (e.g., guardianship)
• Participation in another interventional clinical trial
• Uncontrolled diabetes
• Unstable psychiatric disorders
• Adults unable to provide informed consent
• Contraindication to corticosteroid therapy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• Hopital Robert Ballanger — Aulnay-sous-Bois

Идентификаторы

NCT: NCT07440238 · APHP240792 · 2025-522193-37-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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