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NCT Number: NCT03065244

KIDCARE (Kawasaki Disease Comparative Effectiveness Trial)

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.

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Key information

Conditions

Mucocutaneous Lymph Node Syndrome Cardiovascular Diseases Hemic and Lymphatic Diseases Lymphatic Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Vascular Diseases Vasculitis

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

UAB Children's of Alabama, Birmingham, Alabama, United States

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About this study

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.

  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

IVIG

Drug

Subjects randomized to this arm will receive IVIG 2g/kg over 10-12 hours

Other names: Intravenous immunoglobulin

Infliximab

Drug

Subjects randomized to this arm will receive infliximab 10 mg/kg over 2 hours

Other names: Remicade

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.

    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.

Secondary outcomes

  1. Change in White Blood Cell Count (WBC) Between Baseline and 24 Hours and 2 Weeks Following Study Treatment.

    Time frame: 24h

    Change in white blood cell count (WBC), between baseline and 24 hours and 2 weeks following study treatment.

  2. 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. A Z-score >= 2.5 is considered a aneurysm according to the American Heart Association criteria.

  3. 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.

  4. Duration of Hospitalization

    Time frame: 2 weeks

    How long a participant was hospitalized for.

  5. Number of Participants With IVIG and Infliximab Infusion Reactions and Complications

    Time frame: 7 days

    Determine any complications and/or reactions to each treatment.

  6. Change in Absolute Neutrophil Count (ANC) Between Baseline and 24 Hours and 2 Weeks Following Study Treatment.

    Time frame: 24h

    Change in absolute neutrophil count (ANC) between baseline and 24 hours and 2 weeks following study treatment.

  7. Change in C-reactive Protein (CRP, mg/dL) Concentration Between Baseline and 24 Hours and 2 Weeks Following Study Treatment.

    Time frame: 24h

    Change in C-reactive protein (CRP, mg/dL) concentration between baseline and 24 hours and 2 weeks following study treatment.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Acronym: KIDCARE

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Feb 27, 2017
Registry last updated
Dec 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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