Alpha-Defensin and Synovial Proteins to Improve Detection of Pediatric Septic Arthritis

NARecruitingINTERVENTIONAL
Enrollment

442

Participants

Timeline

Start Date

June 28, 2016

Primary Completion Date

May 31, 2026

Study Completion Date

May 31, 2026

Conditions
Joint InfectionInfection of Hip Joint (Disorder)Infection of Shoulder JointSeptic Arthritis
Interventions
DIAGNOSTIC_TEST

Synovial Alpha-defensin assay

One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.

DIAGNOSTIC_TEST

Synovial Neutrophil elastase assay

One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.

DIAGNOSTIC_TEST

Synovial lactate assay

Synovial Fluid (joint fluid) will be sent out to CD Diagnostics for this test.

DIAGNOSTIC_TEST

Synovial C-reactive Protein (CRP)

One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.

DIAGNOSTIC_TEST

Synovial Staphylococcus spp antigen panel

One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.

DIAGNOSTIC_TEST

Synovial Candida spp antigen panel

One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.

DIAGNOSTIC_TEST

Synovial Enterococcus faecalis assay

One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.

DIAGNOSTIC_TEST

Synovial bacterial culture by BacT/Alert

The synovial fluid (joint fluid) sent to CD Diagnostics for testing will also be cultured to see if any organisms grow.

DIAGNOSTIC_TEST

Synovial Cell count + differential (CBC)

One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.

DIAGNOSTIC_TEST

Synovial Gram Stain

This will be performed by CD Diagnostics if any organisms are present in the synovial fluid.

DIAGNOSTIC_TEST

Synovial Leukocyte Esterase Test Strips

These test strips will be tested at the hospital where the patient is being seen, a few drops of synovial fluid will be used on the strip.

DIAGNOSTIC_TEST

Synovial PCR for Kingella kingae

In participants \< 8 years old, a sample of synovial fluid will be tested for Kingella kingae using PCR.

DIAGNOSTIC_TEST

Serum Cell count + differential (CBC)

A blood test performed at the hospital.

DIAGNOSTIC_TEST

Serum erythrocyte sedimentation rate (ESR)

A blood test performed at the hospital.

DIAGNOSTIC_TEST

Serum C-reactive Protein (CRP)

A blood test performed at the hospital.

DIAGNOSTIC_TEST

Serum D-dimer

A blood test performed at the hospital.

DIAGNOSTIC_TEST

Serum Procalcitonin

A blood test performed at the hospital.

DIAGNOSTIC_TEST

Blood Cultures

Blood will be cultured at the hospital to see if any organisms grow.

DIAGNOSTIC_TEST

Optional blood testing per standard of care (ASO, anti-strep, ANA, anti-DS-DNA, HLA-B27, RF, Lyme and other inflammatory/ rheumatologic markers )

In patients with suspected inflammation/infection, there are other blood tests which may be standard of care and used for diagnosis.

Trial Locations (3)

10021

RECRUITING

Hospital for Special Surgery, New York

30342

RECRUITING

Children's Healthcare of Atlanta, Atlanta

38017

NOT_YET_RECRUITING

Campbell Clinic, Collierville

All Listed Sponsors
collaborator

Pediatric Orthopaedic Society of North America

OTHER

collaborator

Children's Healthcare of Atlanta

OTHER

collaborator

Campbell Clinic

OTHER

collaborator

CD Diagnostics

INDUSTRY

lead

Hospital for Special Surgery, New York

OTHER

NCT03704766 - Alpha-Defensin and Synovial Proteins to Improve Detection of Pediatric Septic Arthritis | Biotech Hunter | Biotech Hunter