Evaluation of the Efficacy of Corticosteroids in Septic Arthritis in Adults

NCT07440238 | Not Yet Recruiting Phase 2 DMC

• 2 other identifiers: APHP2407922025-522193-37-00
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Septic Arthritis

Keywords

Articular prognosis; Corticosteroid; Acute septic arthritis; Antibiotic therapy

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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.

  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

  24 weeks

Secondary Outcomes (11)

• To evaluate the effect of corticosteroids on joint range of motion.

  1, 6, and 24 weeks

• To assess joint-related complications.

  24 weeks

• To determine whether corticosteroid administration affects the need for surgical intervention.

  24 weeks

• To evaluate whether corticosteroids modify the duration of antibiotic therapy.

  24 weeks

• To assess the impact of corticosteroids on length of hospital stay.

  24 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

Prednisone 60 mg/day for 7 days.

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

Control group

PLACEBO COMPARATOR

Placebo of prednisone 60 mg/day for 7 days.

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

Interventions

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

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

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hopital Robert Ballanger

Aulnay-sous-Bois, France

Location

MeSH Terms

Conditions

Arthritis, Infectious

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Infections; Arthritis; Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Benjamin ROSSI, PhD

CONTACT

+33 1 45 21 37 58; benjamin.rossi@ght-gpne.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Experimental arm: Standard antibiotic therapy combined with oral prednisone at a dose of 60 mg per day for 7 days Control arm: Standard antibiotic therapy combined with an oral placebo matching prednisone for 7 days.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Exploratory phase II therapeutic trial, multicenter, national, controlled and randomized with a 1:1 allocation ratio, double-blind.

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: February 27, 2026
• Study Start: March 30, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

FR (1)