KIDCARE (Kawasaki Disease Comparative Effectiveness Trial)
KIDCARE
1 other identifier
interventional
105
1 country
29
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2017
Typical duration for phase_3
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2017
CompletedStudy Start
First participant enrolled
February 17, 2017
CompletedFirst Posted
Study publicly available on registry
February 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 2, 2020
CompletedResults Posted
Study results publicly available
December 3, 2021
CompletedDecember 3, 2021
August 1, 2021
3.5 years
January 17, 2017
August 29, 2021
November 5, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Cessation of Fever Within 24h of Initiation of Study Treatment With no Fever Recurrence Within Next 7 Days.
A fever will be considered ≥38°C rectally or orally and ≥ 37.5°C axillary. Cessation of fever within 24h of initiation of study treatment with no fever recurrence within next 7 days.
7 days
Secondary Outcomes (7)
Change in White Blood Cell Count (WBC) Between Baseline and 24 Hours and 2 Weeks Following Study Treatment.
24h
Change in Zworst Score Between Baseline and 2-week (± 4 Days) Echocardiograms
2 weeks
Total Number of Fever Days (24 Hour Period With a T≥38.0°C) From Enrollment
7 days
Duration of Hospitalization
2 weeks
Number of Participants With IVIG and Infliximab Infusion Reactions and Complications
7 days
- +2 more secondary outcomes
Study Arms (2)
IVIG
ACTIVE COMPARATORPatient will be randomly assigned to receive a second IVIG infusion: 2 g/kg IV over 8-10 hours single infusion
Infliximab
ACTIVE COMPARATORPatient will be randomly assigned to receive Infliximab 10 mg/kg IV over 2 hours
Interventions
Subjects randomized to this arm will receive IVIG 2g/kg over 10-12 hours
Subjects randomized to this arm will receive infliximab 10 mg/kg over 2 hours
Eligibility Criteria
You may qualify if:
- Eligible subjects will be as follows:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
UAB Children's of Alabama
Birmingham, Alabama, 35233, United States
Arkansas Children's Hospital
Little Rock, Arkansas, 72202, United States
University of California San Diego
La Jolla, California, 92093, United States
Memorial Care
Long Beach, California, 90806, United States
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
David Geffen School of Medicine at UCLA
Los Angeles, California, 90095, United States
Harbor-UCLA Medical Center
Los Angeles, California, 90502, United States
UCSF Benioff Children's Hospital-Oakland
Oakland, California, 94609, United States
Children's Hospital of Orange County
Orange, California, 92868, United States
UCSF Benioff Children's Hospital-San Francisco
San Francisco, California, 94920, United States
Cedar-Sinai Medical Center
West Hollywood, California, 94305, United States
Children's Hospital of Colorado
Aurora, Colorado, 80045, United States
Children's National Health SYstem
Washington D.C., District of Columbia, 20010, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322, United States
Comer Children's Hospital
Chicago, Illinois, 60637, United States
Riley Children's Health Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
Boston Children's hospital
Boston, Massachusetts, 02115, United States
Children's Hospital of Michigan
Detroit, Michigan, 48201, United States
Children's Mercy Kansas Ciry
Kansas City, Missouri, 64108, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Maria Fareri Children's Hospital
Valhalla, New York, 10595, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
University of South Dakota Sanford School of Medicine
Sioux Falls, South Dakota, 57105, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Children's Medical Center of Dallas
Dallas, Texas, 75235, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
Primary Care University of Utah
Salt Lake City, Utah, 84113, United States
Seattle Children's
Seattle, Washington, 98101, United States
Related Publications (1)
Burns JC, Roberts SC, Tremoulet AH, He F, Printz BF, Ashouri N, Jain SS, Michalik DE, Sharma K, Truong DT, Wood JB, Kim KK, Jain S; KIDCARE Multicenter Study Group. Infliximab versus second intravenous immunoglobulin for treatment of resistant Kawasaki disease in the USA (KIDCARE): a randomised, multicentre comparative effectiveness trial. Lancet Child Adolesc Health. 2021 Dec;5(12):852-861. doi: 10.1016/S2352-4642(21)00270-4. Epub 2021 Oct 27.
PMID: 34715057DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Jane Burns
- Organization
- Dept. of Pediatrics UCSD School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Jane C Burns, MD
UCSD
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 17, 2017
First Posted
February 27, 2017
Study Start
February 17, 2017
Primary Completion
August 31, 2020
Study Completion
November 2, 2020
Last Updated
December 3, 2021
Results First Posted
December 3, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share