A Blood Test to Diagnose Kawasaki Disease

Status Not yet recruiting

Clinical Trial Summary

A case-control cohort study is being conducted to develop and validate the performance of a whole blood gene expression qPCR test to distinguish KD from other febrile conditions by collecting whole blood sample from KD patients in the first 7 days of illness and from febrile controls immediately after presentation and before clinical diagnosis is confirmed.

Clinical Trial Description

Currently, there is no diagnostic tool for Kawasaki disease (KD). Diagnosis is based on clinical features shared with other febrile conditions, frequently resulting in delayed or missed treatment and an increased risk of coronary artery aneurysms. An accurate diagnostic blood test might enable early discrimination of Kawasaki disease from other infectious and inflammatory conditions, resulting in a precise clinical treatment to improves survival and quality of children's life. The purpose of this study is to develop and validate a blood-based assay for accurate diagnosis of KD in in the first 7 days of illness. The study will collect blood samples from healthy patients with no recent history of fever or immunization and from febrile patients diagnosed with KD or other infectious and inflammatory diseases. Three types of patients in this study: Cohort A: Children ages 6-60 months old who have been diagnosed with (or strong clinical suspicion for) KD by clinician. Blood samples must be collected before any treatment has been initiated. Cohort B: Children ages 6-60 months old with febrile conditions who have been diagnosed with other infections or inflammation by clinician. Blood samples must be collected before any treatment. Cohort C: Children ages 6-60 months old with no recent history of fever or immunization. ;

Study Design

Related Conditions & MeSH terms

Kawasaki Disease
Mucocutaneous Lymph Node Syndrome

Clinical Trial Details

NCT number	NCT05091229
Study type	Observational
Source	HBI Solutions Inc.
Contact	James Schilling
Phone	6504279198
Email	admin@mprobe.com
Status	Not yet recruiting
Phase
Start date	July 2023
Completion date	December 2024

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT05911386` - Multiparametric Echocardiography and Cardiac Biomarkers in Pediatric Inflammatory Heart Diseases
Recruiting	`NCT02951234` - A Multi-center, Randomized to Compare the Efficacy of IVIG Alone and IVIG Plus High-dose Aspirin in Kawasaki Disease	N/A
Active, not recruiting	`NCT02853266` - Measurement of Antibodies in Adults With a History of Kawasaki Disease	N/A
Active, not recruiting	`NCT04747847` - Pilot Study of Atorvastatin and Anakinra in Children With Coronary Artery Abnormalities Secondary to Kawasaki Disease	Early Phase 1
Withdrawn	`NCT04535518` - Efficacy of Immunoglobulin Plus Infliximab for the Early Regression of Coronary Artery Lesion in Kawasaki Disease	Phase 3
Recruiting	`NCT01917721` - Doxycycline Treatment to Prevent Progressive Coronary Artery Dilation in Children With Kawasaki Disease	Phase 2
Recruiting	`NCT04656184` - A Trial Comparing the Efficacy and Safety of Anakinra Versus Intravenous Immunoglobulin (IVIG) Retreatment, in Patients With Kawasaki Disease Who Failed to Respond to Initial Standard IVIG Treatment	Phase 3
Recruiting	`NCT03200561` - A Trial to Evaluate the Efficacy of Immunoglobulin Plus Steroid for Prevention of Coronary Artery Abnormalities in Taiwanese Refractory Kawasaki Disease (RAST Study)	Phase 3
Completed	`NCT01440075` - Prevalence and Early Markers of Atherosclerosis in Adults With a History of Kawasaki Disease	N/A
Completed	`NCT02179853` - Anakinra in Infants and Children With Coronary Artery Abnormalities in Acute Kawasaki Disease	Phase 1/Phase 2
Withdrawn	`NCT02980263` - Study of Efficacy and Safety of Canakinumab in Pediatric Patients With Kawasaki Disease	Phase 2
Enrolling by invitation	`NCT02359643` - Multi-center Prospective Randomized Control Trail of High Dose Aspirin in Acute Stage of Kawasaki Disease	N/A
Recruiting	`NCT04278404` - Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
Completed	`NCT00841789` - A Randomized, Double Blind, Placebo Controlled Study of Etanercept in Children With Kawasaki Disease	Phase 2
Completed	`NCT00760435` - Infliximab Plus Intravenous Immunoglobulin for the Primary Treatment of Kawasaki Disease	Phase 3
Not yet recruiting	`NCT05643651` - Rivaroxaban for Children With Giant Coronary Artery Aneurysms After Kawasaki Disease	Phase 4
Recruiting	`NCT02114099` - Trial of Atorvastatin on the Persistent Coronary Aneurysm in Children With Kawasaki Disease	Phase 2
Completed	`NCT01431105` - Pharmacokinetics (PK)/Safety Study of Atorvastatin in Children With Kawasaki Disease and Coronary Artery Abnormalities	Phase 1/Phase 2
Recruiting	`NCT01793168` - Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Recruiting	`NCT06305611` - European and North Indian Cohort of KaWasaki dIsease