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Trial record 70 of 74 for:    lyme

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

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ClinicalTrials.gov Identifier: NCT03704766
Recruitment Status : Recruiting
First Posted : October 15, 2018
Last Update Posted : October 15, 2018
Sponsor:
Collaborators:
Pediatric Orthopaedic Society of North America
Children's Healthcare of Atlanta
Campbell Clinic Orthopaedics
CD Diagnostics
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Joint Infection Infection of Hip Joint (Disorder) Infection of Shoulder Joint Septic Arthritis Diagnostic Test: Synovial Alpha-defensin assay Diagnostic Test: Synovial Neutrophil elastase assay Diagnostic Test: Synovial lactate assay Diagnostic Test: Synovial C-reactive Protein (CRP) Diagnostic Test: Synovial Staphylococcus spp antigen panel Diagnostic Test: Synovial Candida spp antigen panel Diagnostic Test: Synovial Enterococcus faecalis assay Diagnostic Test: Synovial bacterial culture by BacT/Alert Diagnostic Test: Synovial Cell count + differential (CBC) Diagnostic Test: Synovial Gram Stain Diagnostic Test: Synovial Leukocyte Esterase Test Strips Diagnostic Test: Synovial PCR for Kingella kingae Diagnostic Test: Serum Cell count + differential (CBC) Diagnostic Test: Serum erythrocyte sedimentation rate (ESR) Diagnostic Test: Serum C-reactive Protein (CRP) Diagnostic Test: Serum D-dimer Diagnostic Test: Serum Procalcitonin Diagnostic Test: Blood Cultures 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 ) Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 442 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants are assigned as either cases of infection/inflammation, or normative controls, and receive the same diagnostic testing for the duration of the study.
Masking: Double (Participant, Care Provider)
Masking Description: For patients with inflamed joints, the medical team will be blind to the results of the alpha-defensin assay and other experimental tests for a period of 2 weeks, after which results may be divulged to the clinical team at their request. As such, the results will not influence the physician/surgeons' decision for acute treatment of the patient, as the decision to treat suspected septic arthritis is typically made within 24 hours, and the final diagnosis is made within 2 weeks (pending culture results). As the testing of the leukocyte esterase strips will occur in the operating room, the surgeon will not be blinded to these results. A blinded team member will read the pictures of all of the leukocyte test strip results at once, after they have all been collected. The patient will be made aware of results at the physician/surgeon's discretion. For normative controls, the results of experimental testing will not be divulged to the clinical team or to the patient.
Primary Purpose: Diagnostic
Official Title: Alpha-Defensin and Synovial Proteins to Improve Detection of Pediatric Septic Arthritis
Actual Study Start Date : July 15, 2016
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Inflamed/Infected Joint
Patients undergoing joint aspiration/debridement due to suspicion of septic joint or rheumatologic/inflammatory condition
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.

Active Comparator: Normative Control
Patient undergoing procedure unrelated to infection/inflammation
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.




Primary Outcome Measures :
  1. Sensitivity and specificity of experimental tests [ Time Frame: Interim analysis at 2 years of study recruitment ]
    Sensitivity and specificity have been selected as these are standard outcome tests when determining the utility of a diagnostic test.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03704766


Contacts
Contact: Grace Wang, BA 212-774-2121 wangg@hss.edu

Locations
United States, Georgia
Children's Healthcare of Atlanta Recruiting
Atlanta, Georgia, United States, 30342
Contact: Jack Goldberg, MS    678-686-6864    Jack.Goldberg@choa.org   
Contact: Tim Schrader, MD    (404) 255-1933      
United States, New York
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Contact: Grace Wang, BA    212-774-2121    wangg@hss.edu   
Contact: Emily R Dodwell, MD, MPH    212-606-1451      
Principal Investigator: Emily R Dodwell, MD, MPH         
Sub-Investigator: Joseph J Ruzbarsky, MD         
Sub-Investigator: Roger F Widmann, MD         
Sub-Investigator: Daniel W Green, MD         
Sub-Investigator: John S Blanco, MD         
Sub-Investigator: David M Scher, MD         
Sub-Investigator: Shevaun M Doyle, MD         
Sub-Investigator: Peter D Fabricant, MD, MPH         
Sub-Investigator: Christine M Salvatore, MD         
Sub-Investigator: Matthew Greenblatt, MD, PhD         
Sub-Investigator: Huong Do, MS         
United States, Tennessee
Campbell Clinic Not yet recruiting
Collierville, Tennessee, United States, 38017
Contact: Jonathan Rowland    901-287-5413    Jonathan.Rowland@lebonheur.org   
Contact: Derek Kelly, MD    (901) 759-3100      
Sponsors and Collaborators
Hospital for Special Surgery, New York
Pediatric Orthopaedic Society of North America
Children's Healthcare of Atlanta
Campbell Clinic Orthopaedics
CD Diagnostics
Investigators
Principal Investigator: Emily R Dodwell, MD, MPH The Hospital for Special Surgery

Additional Information:
Publications:

Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT03704766     History of Changes
Other Study ID Numbers: 2015-947
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Collaborating sites will share de-identified patient data with the primary site, the Hospital for Special Surgery. The Hospital for Special Surgery, will incorporate de-identified aggregated data into a separate de-identified aggregated data sat to be provided to all study sites, but individual participant data will not be shared with all sites.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospital for Special Surgery, New York:
synovial biomarkers
alpha-defensin
diagnostics
pediatric

Additional relevant MeSH terms:
Infection
Communicable Diseases
Arthritis
Arthritis, Infectious
Joint Diseases
Musculoskeletal Diseases
Calcitonin
Defensins
alpha-Defensins
Bone Density Conservation Agents
Physiological Effects of Drugs
Anti-Infective Agents