KIDCARE (Kawasaki Disease Comparative Effectiveness Trial)

Completed · Phase 3

Conditions studied: Mucocutaneous Lymph Node Syndrome

In brief

Kawasaki disease (KD) is a self-limited illness that affects the heart blood vessels (coronary arteries) of infants and children and is now the most common cause of acquired heart disease in children. A mixture of proteins from human blood (Intravenous immunoglobulin, IVIG) is a treatment that reduces the rate of the major complication of the disease: a bulging of the wall of the coronary arteries called an aneurysm. However, 10-20% of children are resistant to this treatment and the fever returns. These children have the highest rates of aneurysm formation and thus should be treated aggressively. Unfortunately, there are no guidelines for the best secondary treatment for these resistant patients because the problem has never been adequately studied. Most physicians choose either a second infusion of IVIG or an engineered antibody called infliximab that inactivates a molecule that promotes inflammation. This trial will randomize (assign by chance like the flip of a coin) IVIG-resistant patients to receive either a second IVIG infusion or infliximab and the response to treatment will be compared to learn which treatment stops the fever the fastest. In addition, parents and caregivers will provide observations about their child's response to the different treatments.

Key facts

Study ID

NCT03065244

Run by

University of California, San Diego

People needed

105

Starts

2017-02-17

Expected to finish

2020-11-02

Last updated by the study team

2021-12-03

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Eligible subjects will be as follows:
• 4 weeks to 17 years of age,
• fulfill the American Heart Association case definition for complete or incomplete KD,
• have had fever (T ≥38°C) for 3 to 10 days prior to initial IVIG treatment,
• have fever (T ≥38°C orally or rectally) between 36 hours and 7 days after end of the first IVIG infusion without other likely cause

You may not qualify if…

• Patient treated with infliximab or steroids for present illness (pts who received oral steroids as outpatients prior to KD diagnosis but who otherwise qualify for the study will not be excluded)
• Known prior infection with tuberculosis, coccidiomycosis, or histoplasmosis.

Where it is running

• UAB Children's of Alabama — Birmingham, Alabama, United States
• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• University of California San Diego — La Jolla, California, United States
• Memorial Care — Long Beach, California, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• David Geffen School of Medicine at UCLA — Los Angeles, California, United States
• Harbor-UCLA Medical Center — Los Angeles, California, United States
• UCSF Benioff Children's Hospital-Oakland — Oakland, California, United States
• Children's Hospital of Orange County — Orange, California, United States
• UCSF Benioff Children's Hospital-San Francisco — San Francisco, California, United States
• Cedar-Sinai Medical Center — West Hollywood, California, United States
• Children's Hospital of Colorado — Aurora, Colorado, United States
• Children's National Health SYstem — Washington D.C., District of Columbia, United States
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Comer Children's Hospital — Chicago, Illinois, United States
• Riley Children's Health Indiana University School of Medicine — Indianapolis, Indiana, United States
• Boston Children's hospital — Boston, Massachusetts, United States
• Children's Hospital of Michigan — Detroit, Michigan, United States
• Children's Mercy Kansas Ciry — Kansas City, Missouri, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Maria Fareri Children's Hospital — Valhalla, New York, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• UPMC Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• University of South Dakota Sanford School of Medicine — Sioux Falls, South Dakota, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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