Septic ArthritisPhase 2CORSARNCT07440238
Evaluation of the Efficacy of Corticosteroids in Septic Arthritis in Adults
A Phase 2 study of Septic Arthritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Arthritis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 30 Mar 2026to Sep 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of the Efficacy of Corticosteroids in Septic Arthritis in Adults: Randomized Double-blind Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Septic Arthritis
- Being tested
- oral prednisone or placebo at a dose of 60 mg per day for 7 days
- Keywords
- Articular prognosis, Corticosteroid, Acute septic arthritis, Antibiotic therapy
- Medical subject headings
- Arthritis, Infectious
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral prednisone or placebo at a dose of 60 mg per day for 7 daysDrug
oral prednisone or placebo at a dose of 60 mg per day for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Prednisone 60 mg/day for 7 days. Receives: 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. Receives: Drug: oral prednisone or placebo at a dose of 60 mg per day for 7 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 24 weeks
Secondary outcomes (11)
To evaluate the effect of corticosteroids on joint range of motion.
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.
Measured: 1, 6, and 24 weeks
To assess joint-related complications.
Any complication assessed by radiological examination of the joint at week 24.
Measured: 24 weeks
To determine whether corticosteroid administration affects the need for surgical intervention.
Number of surgical interventions between randomization and week 24.
Measured: 24 weeks
To evaluate whether corticosteroids modify the duration of antibiotic therapy.
Duration of antibiotic therapy.
Measured: 24 weeks
To assess the impact of corticosteroids on length of hospital stay.
Length of hospital stay
Measured: 24 weeks
To evaluate the effect of corticosteroids on pain.
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
Measured: 24 weeks
To assess the effect of corticosteroids on overall mortality.
Overall mortality.
Measured: 24 weeks
To evaluate the impact of corticosteroids on systemic inflammation.
Biological inflammatory markers measured at weeks 1, 6, and 24.
Measured: 24 weeks
To assess the effect of corticosteroids on patient-reported recovery.
Patient self-assessment of recovery on a 0 to 5 scale (0 = no improvement, 5 = full recovery) at weeks 1, 6, and 24.
Measured: 24 weeks
To evaluate the impact of corticosteroids on quality of life.
Quality of life assessed by the EQ-5D-5L questionnaire at week 24.
Measured: 24 weeks
To assess corticosteroid tolerance, including glycemic control and neuropsychiatric effects.
All adverse effects and side effects, particularly glycemic control and neuropsychiatric effects, monitored through patient self-surveillance.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start30 Mar 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ArthritisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Exploratory phase II therapeutic trial, multicenter, national, controlled and randomized with a 1:1 allocation ratio, double-blind.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07440238
- Sponsor's protocol ID
- APHP240792
- Other IDs
- 2025-522193-37-00, 2025
- Acronym
- CORSAR
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Corticosteroids in Septic Arthritis in Adults: Randomized Double-blind Controlled Trial
- ClinicalTrials.gov ID
- NCT07440238
- Acronym / sponsor ID
- CORSAR / APHP240792
- Conditions
- Septic Arthritis
- Keywords
- Articular prognosis, Corticosteroid, Acute septic arthritis, Antibiotic therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 30 Mar 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Exploratory phase II therapeutic trial, multicenter, national, controlled and randomized with a 1:1 allocation ratio, double-blind.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: oral prednisone or placebo at a dose of 60 mg per day for 7 daysPrednisone 60 mg/day for 7 days. |
| Control group | Placebo comparator | Drug: oral prednisone or placebo at a dose of 60 mg per day for 7 daysPlacebo of prednisone 60 mg/day for 7 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral prednisone or placebo at a dose of 60 mg per day for 7 daysoral prednisone or placebo at a dose of 60 mg per day for 7 days | Drug | Control group, Experimental group |
Primary outcome
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.
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
11 secondary outcomes
To evaluate the effect of corticosteroids on joint range of motion.
Time frame: 1, 6, and 24 weeks
To assess joint-related complications.
Time frame: 24 weeks
To determine whether corticosteroid administration affects the need for surgical intervention.
Time frame: 24 weeks
To evaluate whether corticosteroids modify the duration of antibiotic therapy.
Time frame: 24 weeks
To assess the impact of corticosteroids on length of hospital stay.
Time frame: 24 weeks
To evaluate the effect of corticosteroids on pain.
Time frame: 24 weeks
To assess the effect of corticosteroids on overall mortality.
Time frame: 24 weeks
To evaluate the impact of corticosteroids on systemic inflammation.
Time frame: 24 weeks
To assess the effect of corticosteroids on patient-reported recovery.
Time frame: 24 weeks
To evaluate the impact of corticosteroids on quality of life.
Time frame: 24 weeks
To assess corticosteroid tolerance, including glycemic control and neuropsychiatric effects.
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Septic Arthritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin ROSSI, PhD (+33 1 45 21 37 58, benjamin.rossi@ght-gpne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.