A Blood Test to Diagnose Kawasaki Disease

Kawasaki Disease Clinical Trial

Official title:

A Cohort Study to Evaluate a Blood Test for Early-screening of Kawasaki Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05091229
• Other study ID #: KD_001
• Status: Not yet recruiting
• Start date: July 2023
• Est. completion date: December 2024

Study information

• Verified date: March 2023
• Source: HBI Solutions Inc.
• Contact: James Schilling
• Phone: 6504279198
• Email: admin[@]mprobe.com
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 800
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 5 Years

Eligibility

COHORT A

Inclusion Criteria:

• 6- 60 months of age

• Diagnosed with possible Kawasaki disease (even if they do not fulfil the criteria below for Kawasaki disease) by the treating clinician based on the 2004 AHA guidelines

• Appropriate guardian of patients are able and willing to provide blood samples per protocol

• Appropriate guardian of patients are able to comprehend and willing to sign and date the written informed consent document(s) and any applicable medical record release documents for the study

Exclusion Criteria:

• Patient with comorbidities likely to influence gene expression, such as immunosuppressive treatments,

• Have a medical condition which, in the opinion of the investigator, should preclude enrollment into the study.

• Have participated or be currently participating in a clinical research study in which an experimental medication has been administered

COHORT B

Inclusion Criteria:

• 6- 60 months of age

• Diagnosed with febrile illness but without Kawasaki disease presentation criteria

• Appropriate guardian of patients are able and willing to provide blood samples per protocol

• Appropriate guardian of patients are able to comprehend and willing to sign and date the written informed consent document(s) and any applicable medical record release documents for the study

Exclusion Criteria:

• Patient with comorbidities likely to influence gene expression, such as immunosuppressive treatments,

• Have a medical condition which, in the opinion of the investigator, should preclude enrollment into the study.

• Have participated or be currently participating in a clinical research study in which an experimental medication has been administered

COHORT C

Inclusion Criteria:

• 6- 60 months of age

• no recent history of fever or immunization

• Appropriate guardian of patients are able and willing to provide blood samples per protocol

• Appropriate guardian of patients are able to comprehend and willing to sign and date the written informed consent document(s) and any applicable medical record release documents for the study

Exclusion Criteria:

• Patient with comorbidities likely to influence gene expression, such as immunosuppressive treatments,

• Have a medical condition which, in the opinion of the investigator, should preclude enrollment into the study.

• Have participated or be currently participating in a clinical research study in which an experimental medication has been administered

Related Conditions & MeSH terms

• Kawasaki Disease
• Mucocutaneous Lymph Node Syndrome

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
HBI Solutions Inc.	mProbe Inc., Shanghai Children's Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis of Kawasaki Disease	Diagnosis of KD in patients made by KD experts (pediatric infectious disease or pediatric rheumatologists) based on the 2004 AHA guidelines.	4 weeks
Secondary	Coronary artery status	Coronary artery status and Z-score (SD from the mean adjusted for body surface area) for patients with KD, will be recorded. Coronary artery status will be classified as normal (right coronary artery (RCA) and left anterior descending (LAD) Z-score always <2.5) or abnormal (RCA and/or LAD Z-score =2.5 within the first 6 weeks after diagnosis).	6 weeks
Secondary	Coronary artery aneurysm	Echo findings with coronary artery aneurysm	6 weeks