Evaluation of the Efficacy of Corticosteroids in Septic Arthritis in Adults

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Drug 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

Primary outcome measures

• 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. [Time frame: 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. [Time frame: 24 weeks]

Secondary outcome measures (11)

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

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

France · 1 center

• Hopital Robert Ballanger — Aulnay-sous-Bois

Identifiers

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

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗