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Diagnostic Tests for Pediatric Septic Arthritis
N/A
Recruiting
Led By Emily R Dodwell, MD, MPH
Research Sponsored by Hospital for Special Surgery, New York
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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)
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up interim analysis at 2 years of study recruitment
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing different ways to figure out if a child has septic arthritis, which is a serious infection of the joints.
Who is the study for?
This trial is for children with joint inflammation who are undergoing procedures to assess for infection or inflammatory diseases. It includes those with recent antibiotic use, covering various joints like the hip, knee, and shoulder. Children not being assessed for infection-related procedures are excluded.
What is being tested?
The study tests several synovial biomarkers' ability to diagnose pediatric septic arthritis quickly and accurately. This includes assays for alpha-defensin, neutrophil elastase, bacterial cultures, antigen panels, lactate levels among others compared to standard blood tests.
What are the potential side effects?
Since this trial involves diagnostic testing rather than treatment interventions, there are no direct side effects from the tests themselves; however routine risks associated with drawing blood and obtaining synovial fluid may apply.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had fluid taken from my joints to check for infection or inflammation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ interim analysis at 2 years of study recruitment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~interim analysis at 2 years of study recruitment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Sensitivity and specificity of experimental tests
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Inflamed/Infected JointExperimental Treatment19 Interventions
Patients undergoing joint aspiration/debridement due to suspicion of septic joint or rheumatologic/inflammatory condition
Group II: Normative ControlActive Control19 Interventions
Patient undergoing procedure unrelated to infection/inflammation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Serum Procalcitonin
2014
N/A
~110
Find a Location
Who is running the clinical trial?
Hospital for Special Surgery, New YorkLead Sponsor
250 Previous Clinical Trials
60,894 Total Patients Enrolled
Campbell ClinicOTHER
13 Previous Clinical Trials
1,566 Total Patients Enrolled
Pediatric Orthopaedic Society of North AmericaOTHER
7 Previous Clinical Trials
1,018 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am having a surgery not related to an infection.I have had fluid taken from my joints to check for infection or inflammation.You can participate in the study if you have taken antibiotics recently, but your data will be analyzed separately.
Research Study Groups:
This trial has the following groups:- Group 1: Normative Control
- Group 2: Inflamed/Infected Joint
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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