An Explorative Study for Finding Optimal Indication Criteria for Immunomodulatory Therapy in Patients with Kawasaki Disease (FORKiDs trial)

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适应症

试验速览

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•Pediatric patients who meet the revised Diagnostic Guidelines for Kawasaki Disease version 6
•Pediatric patients aged 4 months or older and younger than 15 years at the time of informed consent
•Pediatric patients for whom diagnosis was made before Disease Day 9 (The day on which fever developed is defined as Disease Day 1)
•Pediatric patients whose legal representative provided the consent in writing

•Pediatric patients who achieved defervescence before registration
•Pediatric patients whose main disease condition is likely to be hemolytic streptococcal infection, EB virus infection, adenovirus infection, Yersinia infection, measles, or Stevens-Johnson syndrome, which are diseases similar to Kawasaki disease
•Pediatric patients who started to receive treatment on or after Disease Day 9
•Pediatric patients who are receiving tacrolimus (excluding topical preparation), pitavastatin, rosuvastatin, bosentan, aliskiren, grazoprevir, or pemafibrate
•Pediatric patients who had experienced hypersensitivity to ciclosporin preparation, immunoglobulin preparation, or aspirin in the past
•Pediatric patients whose condition is complicated by active bacterial infections including sepsis, purulent meningitis, peritonitis, and bacterial pneumonia
•Pediatric patients who received administration of another study medication within 12 weeks before the start of study medication administration
•Pediatric patients who were vaccinated with live vaccine/BCG within 4 weeks before the start of study medication administration or inactivated vaccine within 2 weeks before the start of study medication administration
•Other pediatric patients who were judged to be ineligible for safe implementation of this study by the investigators or the sub-investigators.

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