Evaluation of the Efficacy of Corticosteroids in Septic Arthritis in Adults (NCT07440238) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Evaluation of the Efficacy of Corticosteroids in Septic Arthritis in Adults
France200 participantsStarted 2026-03-30
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 cortic…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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.
Timeframe: 24 weeks
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.