Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:35 AM
Ignite Modification Date:
2025-12-25 @ 2:35 AM
NCT ID:
NCT02951234
Eligibility Criteria:
Inclusion Criteria:
1\. Male or female, under the age of 7 years old.
2\. Fulfilled the AHA criteria for KD as explained below:
1. Fever (more than 38.0℃ ear temperature) \> or = 5 days, as well as 4 of the 5 following symptoms
2. Diffuse mucosal inflammation (strawberry tongue, dry and cracked lips)
3. Bilateral non-purulent conjunctivitis
4. Dysmorphous skin rashes
5. Indurative edematous change over the hands and feet, or desquamation over the fingertips or toes
6. Cervical lymphadenopathy (one or more nodule at least 1.5 cm in diameter)
3\. An informed consent form (ICF, appendix B) signed by the patient or a legal guardian.
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Exclusion Criteria:
1. Had symptoms that did not completely match the KD criteria.
2. Had an acute fever for \< 5 days and \>10 days
3. IVIG treatment at another hospital before being referred to the study center.
4. Treatment with corticosteroids, other than the inhaled form, in the two weeks prior to joining the study;
5. The presence of a disease known to mimic Kawasaki disease (such as adenovirus infection, toxic shock syndrome etc.).
6. Previous KD diagnosis.
7. Inability to take aspirin (such as history of hypersensitivity to aspirin, G6PD deficiency, recent herpes zoster infection or vaccination, etc.)
8. Afebrile prior to enrollment
9. CAL prior to enrollment
10. Severe concomitant medical disorders (e.g., immunodeficiency, chromosomal anomalies, congenital heart diseases, metabolic diseases, nephritis, collagen diseases, etc.)
11. Suspected to have an infectious disease, including sepsis, septic meningitis, peritonitis, bacterial pneumonia, varicella, and influenza
12. Judged by the researcher to be unsuitable for this trial.
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Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
7 Years
Study:
NCT02951234
Study Brief:
Protocol Section:
NCT02951234