Results Summary

What was the research about?

Kawasaki disease is a rare childhood illness that inflames blood vessels. Symptoms include high fever; rash; and swollen tongue, hands, and feet. The disease can sometimes cause a dangerous bulge, called an aneurysm, in the blood vessels that supply the heart.

Most children recover from Kawasaki disease after treatment with intravenous immunoglobulin, or IVIG. But in 10 to 20 percent of children, fever persists or returns, which doctors call resistant Kawasaki disease. These children have a high risk of aneurysm.

In this study, the research team looked at the safety and effectiveness of two treatments for children with resistant Kawasaki disease:

  • A second dose of IVIG
  • A medicine called infliximab

What were the results?

Infliximab was safe and effective for children with resistant Kawasaki disease. Compared with children who received a second dose of IVIG, children who received infliximab:

  • Were less likely to have fever after treatment.
  • Had shorter hospital stays.
  • Had fewer side effects and serious adverse events such as anemia. The research team defined a serious adverse event as one that resulted in a hospital stay, disability, or even death.

The two treatments didn’t differ in:

  • Heart scores that measure if a child has an aneurysm.
  • Lab tests that measure inflammation.

Who was in the study?

The study included 103 children ages 4 weeks to 17 years with resistant Kawasaki disease. All received care at one of 30 health centers across the United States. Among children, 58 percent were White, 18 percent were Black or African American, 11 percent were Asian, 8 percent were more than one race, and less than 4 percent were unknown or other races. The average age was 2, and 57 percent were boys.

What did the research team do?

The research team assigned children by chance to receive either a second dose of IVIG or infliximab. All children had received a first dose of IVIG and had a fever that persisted or returned within 36 hours. Children who still had a fever seven days later took the other treatment.

Parents completed surveys about their child’s symptoms four times on the first day of treatment and then once daily for two weeks. Children had an echocardiogram when they started the study and two weeks after leaving the hospital. An echocardiogram uses sound waves to take pictures of the heart.

People who had Kawasaki disease as children, and parents of children with Kawasaki disease, gave input on the study.

What were the limits of the study?

Doctors across health centers may have interpreted echocardiogram results differently. Also, the study didn’t enroll children who already had aneurysms from Kawasaki disease. Results may differ for these patients.

Future research could look at the best dose of infliximab for children with resistant Kawasaki disease. Studies could also include children with heart damage from Kawasaki disease.

How can people use the results?

Doctors and parents can use these results when considering treatment for children with resistant Kawasaki disease.

Final Research Report

This project's final research report is expected to be available by October 2023.

Journal Citations

The KIDCARE Study compared treatment strategies for resistant Kawasaki disease. The research team assessed the effectiveness of a medicine called infliximab compared to giving a second dose of IVIG. More than 100 children who had resistant disease and received care at 30 health centers across the United States were evaluated. The team found that children who received infliximab had shorter hospital stays and experienced fewer side effects, including anemia, than those given a second dose of IVIG. This is one of few trials to evaluate therapies for a rare group of patients experiencing the already rare condition of Kawasaki disease. These study findings were published in The Lancet Child & Adolescent Health.

Peer-Review Summary

The Peer-Review Summary for this project will be posted here soon.

Conflict of Interest Disclosures

Project Information

Jane C. Burns, MD
Katherine K. Kim, PhD, MPH, MBA
University of California San Diego
A Stakeholder-Driven Comparative Effectiveness Study of Treatments to Prevent Coronary Artery Damage in Patients with Resistant Kawasaki Disease

Key Dates

December 2016
May 2023

Study Registration Information


Has Results
Award Type
Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Populations Populations PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders. View Glossary
Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: February 23, 2023