Evaluation of the Efficacy of Corticosteroids in Septic Arthritis in Adults
ConditionSeptic Arthritis
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
oral prednisone or placebo at a dose of 60 mg per day for 7 days
Drugoral prednisone or placebo at a dose of 60 mg per day for 7 days
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Experimental groupExperimental treatment 1 intervention
Group B: Control groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
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.
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.
Time frame
24 weeks2
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
Time frame
24 weeksSecondary outcomes
1
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.
Time frame
1, 6, and 24 weeks2
To assess joint-related complications.
Any complication assessed by radiological examination of the joint at week 24.
Time frame
24 weeks3
To determine whether corticosteroid administration affects the need for surgical intervention.
Number of surgical interventions between randomization and week 24.
Time frame
24 weeks4
To evaluate whether corticosteroids modify the duration of antibiotic therapy.
Duration of antibiotic therapy.
Time frame
24 weeksSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: