Project Summary

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final. In the meantime, results have been published in peer-reviewed journals, as listed below.

What is the research about?

Kawasaki disease is a rare childhood health problem that inflames blood vessels. It can affect any artery or vein in the body. Symptoms include high fever; rash; dry lips; and swollen tongue, hands, and feet. The illness can sometimes cause a dangerous bulge, called an aneurysm, in the coronary artery.

No one knows what causes Kawasaki disease. Most children recover fully after treatment with intravenous immunoglobin, or IVIG. But 10 to 20 percent of children are resistant to IVIG treatment: The treatment doesn’t work well for them, and the fever comes back. These children have a higher risk of aneurysm. Doctors don’t know what treatment works best for them.

In this study, the research team is comparing two treatments for children whose Kawasaki disease comes back. One treatment is another dose of IVIG. The other is a medicine called infliximab.

Who can this research help?

Doctors and parents of children who have Kawasaki disease and are IVIG resistant can use results from this study when planning treatment.

What is the research team doing?

The research team is working with 30 hospitals across the United States to recruit 250 children who have Kawasaki disease and are IVIG resistant. The team is assigning IVIG-resistant patients by chance to receive either a second dose of IVIG or infliximab. Both are single treatments given at the hospital.

To see if patients’ fever goes away within 24 hours of starting treatment and stays normal for a week, the research team is following up with parents. The team is also tracking patients for

  • Signs of infection
  • Signs of aneurysm
  • Total days with a fever after treatment
  • Total days in the hospital
  • Complications from treatment

Parents of children with Kawasaki disease and adults previously diagnosed with Kawasaki disease are working with the research team to plan and conduct the study. 

Research methods at a glance

Design Elements Description
Design Randomized controlled trial
Population Children ages 4 weeks to 17 years who have a return of fever following initial treatment for Kawasaki disease
  • IVIG
  • infliximab

Primary: cessation of fever within 24 hours of treatment initiation, no recurrence within 7 days

Secondary: cessation of fever within 24 hours of treatment completion, change in white blood cell count, absolute neutrophil count, and high-sensitivity C-reactive protein, change in Zworst score, total number of fever days; duration of hospitalization, treatment reactions and complications

Timeframe Timeframe Length of follow-up for collecting data on primary outcomes. View Glossary 7-day follow-up for primary outcomes

Project Information

Jane 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: August 23, 2022