Efficacy of Prednisone Adjunct to Antibiotic Therapy in Adults with Septic Arthritis: A Randomized Double-Blind Controlled Trial

The primary objective of this study is to evaluate whether the administration of corticosteroids alongside antibiotic therapy modifies the joint prognosis in adults with septic arthritis at 24 weeks. This investigation is clinically relevant for determining the impact of adjunctive steroid use on long-term articular outcomes. 5

The secondary objectives include the assessment of the following:

• Effect on joint range of motion and joint-related complications.
• Impact on the necessity for surgical intervention and the duration of antibiotic treatment.
• Influence on the length of hospital stay and overall mortality.
• Changes in pain levels and analgesic consumption between week 1 and week 6.
• Evaluation of systemic inflammation, patient-reported recovery, and quality of life.
• Assessment of corticosteroid tolerance, specifically regarding glycemic control and neuropsychiatric effects.

The sponsor did not provide information regarding the total number of participants. The study population consists of adult patients, including both males and females, diagnosed with septic arthritis. Eligible individuals must have a documented infection confirmed via intra-articular culture, PCR, Gram stain of turbid synovial fluid, or positive blood cultures. Participants must have initiated effective antibiotic therapy within three days of presentation. Inclusion requires the ability to read, write, and understand French, as well as affiliation with a health insurance system.

This randomized, double-blind, controlled trial is designed to evaluate the efficacy of corticosteroids, specifically prednisone, when administered alongside antibiotic therapy for the treatment of adult septic arthritis. Participants will be assigned to receive either the active test product or a placebo. The study protocol begins with a screening visit to confirm eligibility based on criteria such as age, documented infection, and the initiation of effective antibiotic therapy. Following randomization, the primary endpoint is the assessment of joint prognosis at week 24 using the WOMAC score for lower limb involvement or the QuickDASH score for upper limb involvement. Clinical evaluations will occur at multiple intervals, including weeks 1, 6, and 24, to monitor joint flexion and extension, pain via the Visual Analog Scale, and biological inflammatory markers. Secondary outcomes include radiological examination, the number of surgical interventions, hospital stay duration, and quality of life measured by the EQ-5D-5L questionnaire. Throughout the 24-week period, adverse effects, particularly glycemic control and neuropsychiatric effects, will be monitored. The total duration of participant involvement is estimated to be 24 weeks.

The experimental medication consists of prednisone administered as a 60 mg tablet via the oral route. This study evaluates the efficacy of this corticosteroid in the treatment of septic arthritis.

The control group receives a placebo formulated to match the appearance of the 20 mg prednisone tablet.

The primary efficacy endpoint is the functional assessment score evaluated at week 24. Lower limb involvement involving the hip, knee, or ankle joints is measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Upper limb involvement involving the shoulder, elbow, or wrist joints is assessed via the QuickDASH (Disabilities of the Arm, Shoulder and Hand) score. Both indices are standardized and reported on a scale from 0 to 100 points.

Secondary efficacy parameters include:

• Joint flexion and extension measured at weeks 1, 6, and 24 using a goniometer, including the presence of flexion contracture at 3 months for hip and knee involvement.
• Radiological examination of the joint at week 24 to assess complications.
• The number of surgical interventions and the duration of antibiotic therapy between randomization and week 24.
• The length of hospital stay.
• Pain intensity assessed using the Visual Analog Scale (VAS) at weeks 1, 6, and 24.
• Overall mortality.
• Biological inflammatory markers measured at weeks 1, 6, and 24.
• Patient self-assessment of recovery on a scale of 0 to 5 at weeks 1, 6, and 24.
• Quality of life evaluated via the EQ-5D-5L questionnaire at week 24.
• The number of days utilizing painkillers, categorized by WHO level, between week 1 and week 6.
• Adverse effects, specifically glycemic control and neuropsychiatric effects, monitored through patient self-surveillance.