Evaluation of the Efficacy of Corticosteroids in Septic Arthritis in Adults

NCT07440238 · tracked via the Priya Life Science France tracker

Sponsor

Assistance Publique - Hôpitaux de Paris

Phase

Phase 2

Started

2026-03-30

Last updated

2026-02-27

Condition(s) studied

Septic Arthritis

Investigational drug(s) / intervention(s)

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

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

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. — 24 weeks
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). Scores range from 0 to 96 for the total WOMAC where 0 represents the best health status and 96 the worst possible status.
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. — 24 weeks
For upper limb involvement (shoulder, elbow, or wrist joints), the QuickDASH score (Disabilities of the Arm, Shoulder and Hand) will be used. Scores are calculated only for responses with at least 10 of the 11 items completed and transformed to a scale of 0-100, with higher scores indicating greater disability

Trial sites (1)

Facility	City	Region	Status
Hopital Robert Ballanger	Aulnay-sous-Bois	France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07440238 on ClinicalTrials.gov ↗ ← All trials in France