PREDNISONE for Septic arthritis

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 years"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Effective antibiotic therapy initiated within ≤ 3 days"}
• {"criterion_text":"- Signed informed consent"}
• {"criterion_text":"- Affiliation to a health insurance system"}
• {"criterion_text":"- Ability to read, write, and understand French"}

Exclusion criteria

• {"criterion_text":"- Polyarticular septic arthritis (≥ 2 joints)"}
• {"criterion_text":"- Presence of prosthetic joint or osteosynthesis material in the affected joint"}
• {"criterion_text":"- Septic shock"}
• {"criterion_text":"- Severe soft tissue wound overlying the affected joint"}
• {"criterion_text":"- Aplastic chemotherapy"}
• {"criterion_text":"- Neutropenia (defined as neutrophils < 500/mm³)"}
• {"criterion_text":"- Mycobacterial infection"}
• {"criterion_text":"- Fungal infection"}
• {"criterion_text":"- Sickle cell disease"}
• {"criterion_text":"- Current pregnancy"}
• {"criterion_text":"- Breastfeeding women"}
• {"criterion_text":"- Septic arthritis of small joints (e.g., fingers: PIP, DIP, MCP; toes: MTP)"}
• {"criterion_text":"- Patients under legal protection (e.g., guardianship)"}
• {"criterion_text":"- Participation in another interventional drug clinical trial"}
• {"criterion_text":"- Patient unable to provide informed consent"}
• {"criterion_text":"- Systemic sclerosis"}
• {"criterion_text":"- Pyomyositis"}
• {"criterion_text":"- Diabetic foot infection"}
• {"criterion_text":"- Current corticosteroid therapy for another indication"}
• {"criterion_text":"- Inability to take oral medication"}
• {"criterion_text":"- Contraindication to corticosteroids (notably decompensated diabetes or uncontrolled psychiatric disorders)"}
• {"criterion_text":"- Associated endocarditis"}

Primary endpoints

• {"endpoint_text":"- Functional assessment score at week 24. 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). For upper limb involvement (shoulder, elbow, or wrist joints), the QuickDASH score (Disabilities of the Arm, Shoulder and Hand) will be used. The WOMAC or QuickDASH score will be standardized and reported on a scale ranging from 0 to 100 points.","definition_or_measurement_approach":"Assessed at week 24 using total WOMAC for lower limb involvement and QuickDASH for upper limb involvement; scores standardized and reported on a 0–100 scale."}

Secondary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Measured with a goniometer at weeks 1, 6, and 24. Flexion contracture defined as incomplete extension, assessed at 3 months for hip and knee."}
• {"endpoint_text":"- Any complication assessed by radiological examination of the joint at week 24.","definition_or_measurement_approach":"Radiological examination of the joint at week 24 to identify complications."}
• {"endpoint_text":"- Number of surgical interventions between randomization and week 24.","definition_or_measurement_approach":"Count of surgical interventions occurring between randomization and week 24."}
• {"endpoint_text":"- Duration of antibiotic therapy.","definition_or_measurement_approach":"Measured duration (time) of antibiotic therapy (method of measurement as per protocol)."}
• {"endpoint_text":"- Length of hospital stay","definition_or_measurement_approach":"Measured as number of days of hospitalization."}
• {"endpoint_text":"- Pain assessed by Visual Analog Scale (VAS) at weeks 1, 6, and 24.","definition_or_measurement_approach":"Pain measured using VAS at weeks 1, 6 and 24."}
• {"endpoint_text":"- Overall mortality.","definition_or_measurement_approach":"All-cause mortality assessed during follow-up."}
• {"endpoint_text":"- Biological inflammatory markers measured at weeks 1, 6, and 24.","definition_or_measurement_approach":"Measurement of biological inflammatory markers at weeks 1, 6 and 24 (specific markers not listed here)."}
• {"endpoint_text":"- Patient self-assessment of recovery on a 0 to 5 scale (0 = no improvement, 5 = full recovery) at weeks 1, 6, and 24.","definition_or_measurement_approach":"Patient-reported recovery on a 0–5 scale at weeks 1, 6 and 24."}
• {"endpoint_text":"- Quality of life assessed by the EQ-5D-5L questionnaire at week 24.","definition_or_measurement_approach":"EQ-5D-5L questionnaire administered at week 24."}
• {"endpoint_text":"- Number of days on painkillers, overall and according to WHO level (I, II, III), between W1 and W6","definition_or_measurement_approach":"Count of days on analgesics between week 1 and week 6, overall and by WHO level I–III."}
• {"endpoint_text":"- All adverse effects and side effects, particularly glycemic control and neuropsychiatric effects, monitored through patient self-surveillance.","definition_or_measurement_approach":"Monitoring and recording of adverse events, with particular attention to glycaemic control and neuropsychiatric effects via patient self-surveillance."}

France

Earliest CTIS Part Ii Submission Date

16-01-2026

Latest Decision Or Authorization Date

10-02-2026

Processing Time Days

25

Number Of Sites

33

Number Of Participants

200

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"French Ministry of Health (DGOS) : PHRC-I","duties_or_roles":"Monetary support","organisation_type":""}