NCT07440238

Evaluation of the Efficacy of Corticosteroids in Septic Arthritis in Adults

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Septic Arthritis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-03-30
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2026-02-27
• Last updated: 2026-02-27

Locations

1 site across 1 country: France