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KIDCARE (Kawasaki Disease Comparative Effectiveness Trial)

Descriptive Information
Brief Title † KIDCARE (Kawasaki Disease Comparative Effectiveness Trial)
Official Title † KIDCARE (Kawasaki Disease Comparative Effectiveness Trial)
Brief Summary 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.
Detailed Description This is a 3-year (2.75-years of enrollment), Phase III, two-arm, randomized, multi-center, superiority treatment study to compare infliximab to a second intravenous immunoglobulin (IVIG) infusion for treatment of persistent or recrudescent fever in children with KD who fail to become afebrile after the first IVIG infusion. 1. Specific aim 1 will test the hypothesis that infliximab will be superior to a second intravenous immunoglobulin (IVIG) infusion for treatment of persistent or recrudescent fever in children with KD who fail to become afebrile after the first IVIG infusion (resistant KD). Cessation of fever (
Study Phase Phase 3
Study Type † Interventional
Study Design †
Primary Outcome Measure † Cessation of fever within 24h of initiation of study treatment with no fever recurrence within next 7 days.
Secondary Outcome Measure † Cessation of fever within 24h following completion of treatment infusion (Length of infusion is 2h for infliximab and 8-10h for second IVIG)
Condition † Mucocutaneous Lymph Node Syndrome
Intervention † DrugIVIG
Study Arms / Comparison Groups IVIG Patient will be randomly assigned to receive a second IVIG infusion: 2 g/kg IV over 8-10 hours single infusion Infliximab Patient will be randomly assigned to receive Infliximab 10 mg/kg IV over 2 hours
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 250
Start Date † February 17, 2017
Completion Date September 2020
Primary Completion Date January 2020
Eligibility Criteria † Inclusion Criteria: - Eligible subjects will be as follows: 1. 4 weeks to 17 years of age, 2. fulfill the American Heart Association case definition for complete or incomplete KD, 3. have had fever (T ≥38°C) for 3 to 10 days prior to initial IVIG treatment, 4. 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 Exclusion Criteria: 1. 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) 2. Known prior infection with tuberculosis, coccidiomycosis, or histoplasmosis.
Gender All
Ages N/A - 17 Years
Accepts Healthy Volunteers No
Contacts †† Jane C Burns, MD, 858-246-0155, jcburns@ucsd.edu
Location Countries † United States
Administrative Information
NCT ID † NCT03065244
Organization ID UCSD 170064
Secondary IDs ††
Responsible Party Principal Investigator
Study Sponsor † University of California, San Diego
Collaborators †† Patient-Centered Outcomes Research Institute
Investigators † Principal Investigator: Jane C Burns, MD, UCSD
Information Provided By
Verification Date February 2017
First Received Date † January 17, 2017
Last Updated Date February 21, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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