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NCT Number: NCT07440238

Evaluation of the Efficacy of Corticosteroids in Septic Arthritis in Adults

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hopital Robert Ballanger

Aulnay-sous-Bois, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

    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.

  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.

    Time frame: 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

Secondary outcomes

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

    Time frame: 1, 6, and 24 weeks

    Joint flexion and extension measured at weeks 1, 6, and 24 using a goniometer. Presence of flexion contracture (defined as incomplete extension) at 3 months, assessed only for septic arthritis of the hip and knee.

  2. To assess joint-related complications.

    Time frame: 24 weeks

    Any complication assessed by radiological examination of the joint at week 24.

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

    Time frame: 24 weeks

    Number of surgical interventions between randomization and week 24.

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

    Time frame: 24 weeks

    Duration of antibiotic therapy.

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

    Time frame: 24 weeks

    Length of hospital stay

  6. To evaluate the effect of corticosteroids on pain.

    Time frame: 24 weeks

    Pain assessed by Visual Analog Scale (VAS) at weeks 1, 6, and 24. range of scores from 0-10. A higher score indicates greater pain intensity

  7. To assess the effect of corticosteroids on overall mortality.

    Time frame: 24 weeks

    Overall mortality.

  8. To evaluate the impact of corticosteroids on systemic inflammation.

    Time frame: 24 weeks

    Biological inflammatory markers measured at weeks 1, 6, and 24.

  9. To assess the effect of corticosteroids on patient-reported recovery.

    Time frame: 24 weeks

    Patient self-assessment of recovery on a 0 to 5 scale (0 = no improvement, 5 = full recovery) at weeks 1, 6, and 24.

  10. To evaluate the impact of corticosteroids on quality of life.

    Time frame: 24 weeks

    Quality of life assessed by the EQ-5D-5L questionnaire at week 24.

  11. To assess corticosteroid tolerance, including glycemic control and neuropsychiatric effects.

    Time frame: 24 weeks

    All adverse effects and side effects, particularly glycemic control and neuropsychiatric effects, monitored through patient self-surveillance.

Study contacts

Contact information is provided by the study sponsor or research team.

Benjamin ROSSI, PhD

CONTACT

[email protected]

+33 1 45 21 37 58

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: CORSAR

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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