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

Study Purpose

Differentiating between septic arthritis and other causes of joint inflammation in pediatric patients is challenging and of the utmost importance because septic arthritis requires surgical debridement as part of the treatment regimen. The current gold standard to diagnose septic arthritis in children is a positive synovial fluid culture; however, joint cultures may take several days to return. If a bacterial infection is present, it requires immediate surgical intervention in order to prevent lasting articular cartilage damage. Frequently surgeons must decide whether to surgically debride a joint before culture results are available. There is no single lab test or clinical feature that reliably indicates bacterial infection over other causes of joint inflammation. The alpha-defensin assay has shown high sensitivity and specificity for joint infection in other studies.The purpose of this study is to determine the sensitivity and specificity of several synovial biomarkers for diagnosing pediatric septic arthritis.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages N/A - 17 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03704766
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Hospital for Special Surgery, New York
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Emily R Dodwell, MD, MPH
Principal Investigator Affiliation The Hospital for Special Surgery
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOtherOtherOtherIndustry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Joint Infection, Infection of Hip Joint (Disorder), Infection of Shoulder Joint, Septic Arthritis
Study Website: View Trial Website
Additional Details

The purpose of this study is to determine if alpha-defensin and other proteins present in joint fluid may be able to rapidly diagnose bacterial joint infections. Patients with suspected joint infection typically undergo joint aspiration so that tests can be performed to help diagnose joint infection, including gram stain, cell count, and culture. Patients under 18 years old that are undergoing sampling of their joint fluid due to suspicion of infection or inflammation will be enrolled in this multi-center trial. Joint fluid will also be sampled from normative controls made up of patients who are undergoing an unrelated procedure without inflammation or infection. Joint fluid from patients with suspected inflammation/infection and from normative controls will be analysed for presence of alpha-defensin, leukocyte esterase, neutrophil elastase, synovial C-reactive protein, and synovial lactate. The alpha-defensin assay has shown high sensitivity and specificity for joint infection in other studies. Additionally a Staphylococcus spp antigen panel, Candida spp antigen panel, Enterococcus faecalis assay, BACTAlert culture, cell count plus differential, gram stain, and aerobic, anaerobic, and fungal cultures will be done using synovial fluid. A synovial fluid PCR for Kingella kingae will be performed if the patient is under eight years of age. Blood tests will include cell count and differential, erythrocyte sedimentation rate, C-reactive protein, procalcitonin, and D-dimer, as well as relevant inflammatory or rheumatologic marker tests. Results from these tests will be compared to joint fluid culture which the gold standard for diagnosing bacterial infection. The study includes 1 visit per patient, the standard of care visit in which the patient would be undergoing joint aspiration or arthroscopy. Once data has been collected, the sensitivity and specificity will be determined for these experimental tests both individually and in combination.

Arms & Interventions

Arms

Experimental: Inflamed/Infected Joint

Patients undergoing joint aspiration/debridement due to suspicion of septic joint or rheumatologic/inflammatory condition

Active Comparator: Normative Control

Patient undergoing procedure unrelated to infection/inflammation

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Children's Healthcare of Atlanta, Atlanta, Georgia

Status

Recruiting

Address

Children's Healthcare of Atlanta

Atlanta, Georgia, 30342

Site Contact

Jack Goldberg, MS

[email protected]

678-686-6864

Hospital for Special Surgery, New York, New York

Status

Recruiting

Address

Hospital for Special Surgery

New York, New York, 10021

Site Contact

Grace Wang, BA

[email protected]

212-774-2121

Campbell Clinic, Collierville, Tennessee

Status

Not yet recruiting

Address

Campbell Clinic

Collierville, Tennessee, 38017

Site Contact

Jonathan Rowland

[email protected]

901-287-5413