Using alpha-defensin and synovial proteins to diagnose pediatric septic arthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to improve the diagnosis of septic arthritis in children by evaluating the sensitivity and specificity of alpha-defensin and other synovial biomarkers in joint fluid samples. Pediatric patients under 18 years old, suspected of having joint infections, will undergo joint aspiration to collect synovial fluid for analysis. The study will compare samples from patients with suspected infections to those from normative controls undergoing unrelated procedures. Various assays will be performed on the collected fluid to identify potential biomarkers indicative of bacterial joint infections.

Why it matters

Who can join: the full rules

Inclusion Criteria- Septic Cases and Inflamed, Non-Septic Comparators:

* Synovial fluid is obtained to assess for infection or inflammatory/rheumatologic disease (all medium and large joints will be included: hip, knee, ankle, shoulder, subtalar, elbow, and wrist joints)
* Patients with recent antibiotic exposure are eligible to participate but will be analyzed separately

Inclusion Criteria- Normative Controls:

* Patients undergoing a procedure unrelated to infection (the procedure may be arthroscopy, or an open or percutaneous bony or soft tissue procedure)

Exclusion Criteria- All Participants:

* Family declines to participate/consent
* Patients with a major joint trauma (such as a documented ligament tear or fracture) within the past 8 weeks are not eligible to have that joint aspirated, but could have another joint aspirated

Exclusion Criteria- Normative Controls:

* A history of recent infection (within the past 3 months)
* Received antibiotics in the past 7 days

Where it's running

• Children's Healthcare of Atlanta
  Atlanta, Georgia, United States Recruiting
• Hospital for Special Surgery
  New York, New York, United States Recruiting
• Campbell Clinic
  Collierville, Tennessee, United States Not yet recruiting

Study contacts

• Principal investigator: Emily R Dodwell, MD, MPH — The Hospital for Special Surgery
• Study coordinator: Grace Wang, BA
• Email: wangg@hss.edu
• Phone: 212-774-2121

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.