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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

Study 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.Check my eligibility

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.See study design

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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and interim analysis at 2 years of study recruitment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Sensitivity and specificity of experimental tests

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hospital for Special Surgery, New YorkLead Sponsor

243 Previous Clinical Trials

58,888 Total Patients Enrolled

Campbell ClinicOTHER

10 Previous Clinical Trials

1,380 Total Patients Enrolled

Pediatric Orthopaedic Society of North AmericaOTHER

6 Previous Clinical Trials

893 Total Patients Enrolled

Media Library

Synovial PCR for Kingella kingae Clinical Trial Eligibility Overview. Trial Name: NCT03704766 — N/A

Septic Arthritis Research Study Groups: Normative Control, Inflamed/Infected Joint

Septic Arthritis Clinical Trial 2023: Synovial PCR for Kingella kingae Highlights & Side Effects. Trial Name: NCT03704766 — N/A

Synovial PCR for Kingella kingae 2023 Treatment Timeline for Medical Study. Trial Name: NCT03704766 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any remaining opportunities for patients to join this clinical trial?

"Affirmative, according to the data found on clinicaltrials.gov, this trial is currently recruiting participants. The study first launched on June 28th 2016 and was most recently updated on August 5th 2022; it seeks 442 patients across 3 different sites."

Answered by AI

How many people are involved in this clinical trial?

"The trial sponsor, CD Diagnostics, requires 442 candidates fitting the study's criteria at various sites including Children's Healthcare of Atlanta in Georgia and Hospital for Special Surgery in New york."

Answered by AI

Recent research and studies

Clinical Orthopaedics and Related Research®Journal

The Alpha Defensin-1 Biomarker Assay Can Be Used to Evaluate the Potentially Infected Total Joint Arthroplasty

Bingham, Joshua, Henry Clarke, Mark Spangehl, Adam Schwartz, Christopher Beauchamp, and Brynn Goldberg. 2014. “The Alpha Defensin-1 Biomarker Assay Can Be Used to Evaluate the Potentially Infected Total Joint Arthroplasty”. Clinical Orthopaedics and Related Research®. Ovid Technologies (Wolters Kluwer Health). doi:10.1007/s11999-014-3900-7.

Acta Obstetricia et Gynecologica ScandinavicaJournal

Neutrophil Elastase in Amniotic Fluid as a Predictor of Preterm Birth After Emergent Cervical Cerclage

Hatakeyama, Yuko, Hiroshi Miura, Akira Sato, Yohei Onodera, Naoki Sato, Dai Shimizu, Yukiyo Kumazawa, Hiroyuki Sanada, Hideto Hirano, and Yukihiro Terada. 2016. “Neutrophil Elastase in Amniotic Fluid as a Predictor of Preterm Birth After Emergent Cervical Cerclage”. Acta Obstetricia Et Gynecologica Scandinavica. Wiley. doi:10.1111/aogs.12928.

Journal of Diabetes InvestigationJournal

Relationship Between Urinary Sodium Excretion and Pioglitazone-induced Edema

Nakamura, Akinobu, Takeshi Osonoi, and Yasuo Terauchi. 2010. “Relationship Between Urinary Sodium Excretion and Pioglitazone-induced Edema”. Journal of Diabetes Investigation. Wiley. doi:10.1111/j.2040-1124.2010.00046.x.

Academic Emergency MedicineJournal