Clinical Trial: KIDCARE (Kawasaki Disease Comparative Effectiveness Trial)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 Summary:

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 (<38°C rectally or orally) within 24h of initiation of study treatment infusion will be the primary outcome measure.
  2. Specific aim 2 will test the hypothesis that infliximab treatment will result in more rapid resolution of inflammation compared to second IVIG as measured by the change in white blood cell count (WBC), absolute neutrophil count (ANC), and high-sensitivity C-reactive protein (hsCRP) concentration between baseline and 24 hours and 2 weeks following study treatment.
  3. Specific aim 3 will test the hypothesis that infliximab treatment will result in a reduction from baseline in coronary artery Zworst score of ≥ 0.05 standard deviation units as compared to second IVIG at 2 weeks following study treatment measured by echocardiography.

Sponsor: University of California, San Diego

Current Primary Outcome: Cessation of fever within 24h of initiation of study treatment with no fever recurrence within next 7 days. [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Cessation of fever within 24h following completion of treatment infusion (Length of infusion is 2h for infliximab and 8-10h for second IVIG) [ Time Frame: 24 h ]
    A fever will be considered ≥38°C rectally or orally and ≥ 37.5°C axillary. Cessation of fever within 24h following completion of treatment infusion (Length of infusion is 2h for infliximab and 8-10h for second IVIG).
  • Change in white blood cell count (WBC), absolute neutrophil count (ANC), and high-sensitivity C-reactive protein (hsCRP, mg/L) concentration between baseline and 24 hours and 2 weeks following study treatment. [ Time Frame: 24h ]
    Change in white blood cell count (WBC), absolute neutrophil count (ANC), and high-sensitivity C-reactive protein (hsCRP, mg/L) concentration between baseline and 24 hours and 2 weeks following study treatment.
  • Change in Zworst score between baseline and 2-week (± 4 days) echocardiograms [ Time Frame: 2 weeks ]
    Zworst score is defined as the largest internal diameter of either the right coronary or left anterior descending arteries normalized for body surface area and expressed as standard deviation units from the mean.
  • Total number of fever days (24 hour period with a T≥38.0°C) from enrollment [ Time Frame: 7 days ]
    Determine the number of days a participant had a fever once the participant has been enrolled into the study.
  • Duration of hospitalization [ Time Frame: 2 weeks ]
    How long a participant was hospitalized for.
  • IVIG and infliximab infusion reactions and complications [ Time Frame: 7 days ]
    Determine any complications and/or reactions to each treatment.


Original Secondary Outcome: Same as current

Information By: University of California, San Diego

Dates:
Date Received: January 17, 2017
Date Started: February 17, 2017
Date Completion: September 2020
Last Updated: February 21, 2017
Last Verified: February 2017