Evaluation of the efficacy of corticosteroids in septic arthritis in adults: Randomized double-blind controlled trial [CORSAR]

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Assistance Publique Hopitaux De Paris

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

Decision date (initial)

2026-02-10

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

French Ministry of Health (DGOS) : PHRC-I

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To evaluate whether corticosteroid administration alongside antibiotic therapy modifies joint prognosis in adult septic arthritis at 24 weeks

Secondary objectives 12

1. To evaluate the effect of corticosteroids on joint range of motion
2. To assess joint-related complications
3. To determine whether corticosteroid administration affects the need for surgical intervention
4. To evaluate whether corticosteroids modify the duration of antibiotic therapy
5. To assess the impact of corticosteroids on length of hospital stay
6. To evaluate the effect of corticosteroids on pain
7. To assess the effect of corticosteroids on overall mortality
8. To evaluate the impact of corticosteroids on systemic inflammation
9. To assess the effect of corticosteroids on patient-reported recovery
10. To evaluate the impact of corticosteroids on quality of life
11. Assess the impact of corticosteroids on analgesic consumption between week 1 and week 6
12. To assess corticosteroid tolerance, including glycemic control and neuropsychiatric effects

Conditions and MedDRA coding

Septic arthritis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Age ≥ 18 years
2. 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
3. Effective antibiotic therapy initiated within ≤ 3 days
4. Signed informed consent
5. Affiliation to a health insurance system
6. Ability to read, write, and understand French

Exclusion criteria 22

1. Polyarticular septic arthritis (≥ 2 joints)
2. Septic arthritis of small joints (e.g., fingers: PIP, DIP, MCP; toes: MTP)
3. Systemic sclerosis
4. Pyomyositis
5. Diabetic foot infection
6. Current corticosteroid therapy for another indication
7. Inability to take oral medication
8. Contraindication to corticosteroids (notably decompensated diabetes or uncontrolled psychiatric disorders)
9. Associated endocarditis
10. Presence of prosthetic joint or osteosynthesis material in the affected joint
11. Septic shock
12. Severe soft tissue wound overlying the affected joint
13. Aplastic chemotherapy
14. Neutropenia (defined as neutrophils < 500/mm³)
15. Mycobacterial infection
16. Fungal infection
17. Sickle cell disease
18. Current pregnancy
19. Breastfeeding women
20. Patients under legal protection (e.g., guardianship)
21. Participation in another interventional drug clinical trial
22. Patient unable to provide informed consent

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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.

Secondary endpoints 12

1. 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. Any complication assessed by radiological examination of the joint at week 24.
3. Number of surgical interventions between randomization and week 24.
4. Duration of antibiotic therapy.
5. Length of hospital stay
6. Pain assessed by Visual Analog Scale (VAS) at weeks 1, 6, and 24.
7. Overall mortality.
8. Biological inflammatory markers measured at weeks 1, 6, and 24.
9. Patient self-assessment of recovery on a 0 to 5 scale (0 = no improvement, 5 = full recovery) at weeks 1, 6, and 24.
10. Quality of life assessed by the EQ-5D-5L questionnaire at week 24.
11. Number of days on painkillers, overall and according to WHO level (I, II, III), between W1 and W6
12. All adverse effects and side effects, particularly glycemic control and neuropsychiatric effects, monitored through patient self-surveillance.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Assistance Publique Hopitaux De Paris

Sponsor organisation

Assistance Publique Hopitaux De Paris

Address

Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux

City

Paris Cedex 10

Postcode

75475

Country

France

Scientific contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Dr Benjamin ROSSI

Public contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Dr Benjamin ROSSI

Locations

1 EU/EEA country · 33 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 18 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications