Kawasaki DiseaseNCT05091229
A Blood Test to Diagnose Kawasaki Disease
An observational study of Kawasaki Disease, run by HBI Solutions Inc..
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… Read more about this study
- Who is it for?
- Ages 6 months to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Kawasaki Disease
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- Jul 2023to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Primary care clinic
Who may be able to join
- 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
- 6- 60 months of age
- Diagnosed with febrile illness but without Kawasaki disease presentation criteria
Show all 12Show fewer
- 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
- 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
Who cannot join
- 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
- 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.
Show all 11Show fewer
- Have participated or be currently participating in a clinical research study in which an experimental medication has been administered
- COHORT C
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Cohort Study to Evaluate a Blood Test for Early-screening of Kawasaki Disease
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.
Read the detailed 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.
- Conditions
- Kawasaki Disease
- Medical subject headings
- Mucocutaneous Lymph Node Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (2)
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).
Measured: 6 weeks
Coronary artery aneurysm
Echo findings with coronary artery aneurysm
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study startJul 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kawasaki DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HBI Solutions Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Children's Medical Center, mProbe Inc.
- Responsible party
- Principal investigator, Hao Zhang, HBI Solutions Inc.
- Investigators
- Hao Zhang, M.D, Principal investigator, Shanghai Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05091229
- Sponsor's protocol ID
- KD_001
- Status last verified
- Mar 2023
- First submitted
- 12 Oct 2021
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study to Evaluate a Blood Test for Early-screening of Kawasaki Disease
- ClinicalTrials.gov ID
- NCT05091229
- Acronym / sponsor ID
- KD_001
- Conditions
- Kawasaki Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- HBI Solutions Inc.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Children's Medical Center, mProbe Inc.
- Study start
- Jul 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 25 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Primary care clinic
Key inclusion criteria (12 listed)
- 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
- 6- 60 months of age
Key exclusion criteria (11 listed)
- 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
- Patient with comorbidities likely to influence gene expression, such as immunosuppressive treatments,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnosis of Kawasaki Disease
Time frame: 4 weeks
Diagnosis of KD in patients made by KD experts (pediatric infectious disease or pediatric rheumatologists) based on the 2004 AHA guidelines.
2 secondary outcomes
Coronary artery status
Time frame: 6 weeks
Coronary artery aneurysm
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Kawasaki Disease
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 4
Model-informed Dose Optimization for Rivaroxaban in Children With Giant Coronary Artery Aneurysm After Kawasaki Disease
Kawasaki Disease, Pilot Study
Not yet recruitingPhase 2/3
Efficacy and Safety of Immunoglobulin Plus Firsekibart in Patients With Kawasaki Disease
Kawasaki Disease
RecruitingObservational study
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
Coronavirus Infection (COVID-19), Pulmonary Arterial Hypertension
RecruitingPhase 4
Rivaroxaban for Children Aged Over 2 Years With Giant Coronary Artery Aneurysms After Kawasaki Disease
Kawasaki Disease, Coronary Artery Aneurysm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hao Zhang, M.D principal investigator
Shanghai Children's Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Kawasaki Disease, run by HBI Solutions Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James Schilling (6504279198, admin@mprobe.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of Kawasaki Disease (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023; AzTrials last refreshed its copy on 7 Nov 2026.