Kawasaki Disease Clinical Trial
— RASTOfficial title:
A Randomized Open-label Trial to Evaluate the Efficacy of Immunoglobulin Plus Steroid for Prevention of Coronary Artery Abnormalities in Taiwanese Refractory Kawasaki Disease (RAST Study)
Background:
Kawasaki disease (KD), most popular acquired heart disease in childhood, is characterized by
diffuse vasculitis, especially on the middle-sized muscular arteries. IVIG and aspirin are
currently standard treatment. However, 10-15% of KD patients have poor response to such
treatment and suffer from higher risk of coronary involvement. Recently, combination of
prednisolone and IVIG has been shown effective to lower the chance of refractory to IVIG
treatment and subsequent coronary lesions. However, no randomized trial on the steroid
efficacy was ever conducted in Taiwan.
Aim:
Prospectively randomized open-label trial to evaluate the add-on effect of prednisolone in
the refractory KD children.
Methods:
For the KD patients with fever persisted or relapsed 24 hours after the ending of IVIG
infusion, they will be randomized into two group: IVIG group (I) and IVIG + prednisolone
group (P). The KD patients in the P group will have in addition to IVIG, oral prednisolone
2mg/kg/day for at least 5 days. The difference in the response rate and percentage of
coronary involvement will be compared between I and P groups.
Predicted results:
We plan to enroll 100 refractory KD patients, 50 patients for each group. We predict the
risk of coronary involvement can be reduced from 30% to 15%.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 31, 2020 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 20 Years |
Eligibility |
Inclusion Criteria: - KD (Kawasaki disease) patients who failed to respond to the initial IVIG as those who had persistent fever that lasted for more than 24 hours (nonresponse to the initial IVIG) or recrudescent fever associated with KD symptoms after an afebrile period (relapse). Exclusion Criteria: - KD patients, those diagnosed on or after day 9 of illness (the first illness day was defined as the day of fever onset), those with coronary artery abnormalities before enrolment, those who were afebrile before enrolment, those who had received steroids (oral, intravenous, intramuscular, or subcutaneous) in the 30 days before the study or intravenous immunoglobulin in the previous 180 days, those with concomitant severe medical disorders (eg, immunodeficiency, chromosomal anomalies, congenital heart diseases, metabolic diseases, nephritis, collagen diseases), and those with suspected infectious disease, including sepsis, septic meningitis, peritonitis, bacterial pneumonia, varicella, and influenza. |
Country | Name | City | State |
---|---|---|---|
Taiwan | China Medical University Hospital | Taichung |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital |
Taiwan,
Kobayashi T, Kobayashi T, Morikawa A, Ikeda K, Seki M, Shimoyama S, Ishii Y, Suzuki T, Nakajima K, Sakamoto N, Arakawa H. Efficacy of intravenous immunoglobulin combined with prednisolone following resistance to initial intravenous immunoglobulin treatment of acute Kawasaki disease. J Pediatr. 2013 Aug;163(2):521-6. doi: 10.1016/j.jpeds.2013.01.022. Epub 2013 Feb 26. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | maximal coronary z score | echocardiography | one month | |
Secondary | fever more than 38 degree | from end of second course of IVIG | 3 days |
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