NCT05091229

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 25, 2021

Completed
1.7 years until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

March 23, 2023

Status Verified

March 1, 2023

Enrollment Period

1.4 years

First QC Date

October 12, 2021

Last Update Submit

March 22, 2023

Conditions

Kawasaki Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Coronary artery status

    6 weeks

  • Coronary artery aneurysm

    6 weeks

Study Arms (3)

Cohort A

Blood specimen collection. Study samples must be collected prior to any treatment.

Cohort B

Blood specimen collection. Study samples must be collected prior to any treatment.

Cohort C

Blood specimen collection. Study samples must be collected prior to any treatment.

Eligibility Criteria

Age6 Months - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Primary care clinic

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • 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
  • months of age
  • no recent history of fever or immunization
  • Appropriate guardian of patients are able and willing to provide blood samples per protocol
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Mucocutaneous Lymph Node Syndrome

Condition Hierarchy (Ancestors)

VasculitisVascular DiseasesCardiovascular DiseasesLymphatic DiseasesHemic and Lymphatic DiseasesSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Hao Zhang, M.D

    Shanghai Children's Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

James Schilling

CONTACT

6504279198admin@mprobe.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 12, 2021

First Posted

October 25, 2021

Study Start

July 1, 2023

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

March 23, 2023

Record last verified: 2023-03