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Trial of Pulse Steroid Therapy in Kawasaki Disease--Pediatric Heart Network

Primary Purpose

Cardiovascular Diseases, Heart Diseases, Infection

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Steroids
Sponsored by
Carelon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiovascular Diseases

Eligibility Criteria

6 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Fever persisting at least 4 days and the presence of at least 4 of the following 5 principal features: Changes in extremities: Acute changes include erythema and edema of hands and feet; Convalescent changes include membranous desquamation of fingertips Polymorphous exanthema Bilateral, painless bulbar conjunctival injection without exudates Changes in lips and oral cavity: Erythema and cracking of lips, strawberry tongue, diffuse injection of oral and pharyngeal mucosae Cervical lymphadenopathy ( 1.5 cm in diameter), usually unilateral; OR Patients with at least four days of fever and coronary artery disease, defined as either: 1. Having a z-score in either the proximal right coronary artery or the proximal left anterior descending coronary artery of > 2.5 detected by 2-dimensional echocardiography, as well as: For patients under six months of age, at least two principal criteria For patients at least six months of age, at least three principal criteria. 2. Meeting Japanese Ministry of Health criteria for coronary aneurysm defined as an internal lumen diameter of >3 mm in children less than 5 years of age or >4 mm in children 5 years of age and older, in either the proximal right coronary artery or the proximal left anterior descending coronary artery and at least one principal criterion. AND Enrollment within ten days of the onset of illness, with Day 1 defined as the first day of fever AND Informed consent of parents and assent of children who are older than age 7 years and capable of understanding or according to institutional guidelines.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Placebo Comparator

    Arm Label

    1

    Arm Description

    Patients with acute Kawasaki disease

    Outcomes

    Primary Outcome Measures

    Compare the effect of IVMP plus IVIG to IVIG alone on coronary artery outcomes

    Secondary Outcome Measures

    Occurrence of CA aneurysms; individual z scores of the LMCA, proximal RCA, and proximal LAD CA at 1 and 5 weeks; changes in absolute coronary dimensions for all CA segments from baseline to 1 and 5 weeks after randomization

    Full Information

    First Posted
    August 17, 2005
    Last Updated
    March 3, 2014
    Sponsor
    Carelon Research
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI), Pediatric Heart Network
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00132080
    Brief Title
    Trial of Pulse Steroid Therapy in Kawasaki Disease--Pediatric Heart Network
    Official Title
    Trial of Pulse Steroid Therapy in Kawasaki Disease (A Trial Conducted by the Pediatric Heart Network)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2002 (undefined)
    Primary Completion Date
    March 2005 (Actual)
    Study Completion Date
    March 2005 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Carelon Research
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI), Pediatric Heart Network

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The primary endpoint is coronary artery diameter, normalized for body surface area, 5 weeks after randomization. Secondary endpoints include duration of fever, CRP levels, and adverse events.
    Detailed Description
    BACKGROUND: Kawasaki Disease (KD) is an inflammatory vasculitis of unknown etiology that affects infants and children and can cause coronary artery aneurysms. Standard therapy consists of 2 gm/kg of intravenous immune globulin plus high-dose aspirin in the acute phase, and low-dose aspirin in the convalescent phase. Some children do not respond to this therapy, and some children go on to develop coronary artery aneurysms in spite of aggressive treatment. This led to the design of this randomized controlled trial to compare a single dose of intravenous steroids vs. placebo on the background of standard therapy. Recruitment began in December, 2002 and ended in December, 2004 with nearly 200 patients randomized. DESIGN NARRATIVE: This is a randomized controlled trial to compare a single dose of intravenous steroids vs. placebo on the background of standard therapy

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Diseases, Heart Diseases, Infection, Coronary Aneurysm

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    199 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Placebo Comparator
    Arm Description
    Patients with acute Kawasaki disease
    Intervention Type
    Drug
    Intervention Name(s)
    Steroids
    Other Intervention Name(s)
    pulse steroid therapy.
    Intervention Description
    This study evaluates the efficacy and safety of pulse steroid therapy, when added to conventional treatment with IVIG plus aspirin, in treatment of children with acute Kawasaki disease.
    Primary Outcome Measure Information:
    Title
    Compare the effect of IVMP plus IVIG to IVIG alone on coronary artery outcomes
    Time Frame
    Measured 5 weeks post-randomization
    Secondary Outcome Measure Information:
    Title
    Occurrence of CA aneurysms; individual z scores of the LMCA, proximal RCA, and proximal LAD CA at 1 and 5 weeks; changes in absolute coronary dimensions for all CA segments from baseline to 1 and 5 weeks after randomization
    Time Frame
    Measured 5 weeks post-randomization

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Months
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Fever persisting at least 4 days and the presence of at least 4 of the following 5 principal features: Changes in extremities: Acute changes include erythema and edema of hands and feet; Convalescent changes include membranous desquamation of fingertips Polymorphous exanthema Bilateral, painless bulbar conjunctival injection without exudates Changes in lips and oral cavity: Erythema and cracking of lips, strawberry tongue, diffuse injection of oral and pharyngeal mucosae Cervical lymphadenopathy ( 1.5 cm in diameter), usually unilateral; OR Patients with at least four days of fever and coronary artery disease, defined as either: 1. Having a z-score in either the proximal right coronary artery or the proximal left anterior descending coronary artery of > 2.5 detected by 2-dimensional echocardiography, as well as: For patients under six months of age, at least two principal criteria For patients at least six months of age, at least three principal criteria. 2. Meeting Japanese Ministry of Health criteria for coronary aneurysm defined as an internal lumen diameter of >3 mm in children less than 5 years of age or >4 mm in children 5 years of age and older, in either the proximal right coronary artery or the proximal left anterior descending coronary artery and at least one principal criterion. AND Enrollment within ten days of the onset of illness, with Day 1 defined as the first day of fever AND Informed consent of parents and assent of children who are older than age 7 years and capable of understanding or according to institutional guidelines.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lynn Sleeper, ScD.
    Organizational Affiliation
    New England Research Institutes, Watertown, MA
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21185506
    Citation
    Printz BF, Sleeper LA, Newburger JW, Minich LL, Bradley T, Cohen MS, Frank D, Li JS, Margossian R, Shirali G, Takahashi M, Colan SD; Pediatric Heart Network Investigators. Noncoronary cardiac abnormalities are associated with coronary artery dilation and with laboratory inflammatory markers in acute Kawasaki disease. J Am Coll Cardiol. 2011 Jan 4;57(1):86-92. doi: 10.1016/j.jacc.2010.08.619.
    Results Reference
    derived
    PubMed Identifier
    21168857
    Citation
    Sleeper LA, Minich LL, McCrindle BM, Li JS, Mason W, Colan SD, Atz AM, Printz BF, Baker A, Vetter VL, Newburger JW; Pediatric Heart Network Investigators. Evaluation of Kawasaki disease risk-scoring systems for intravenous immunoglobulin resistance. J Pediatr. 2011 May;158(5):831-835.e3. doi: 10.1016/j.jpeds.2010.10.031. Epub 2010 Dec 18.
    Results Reference
    derived
    PubMed Identifier
    19038400
    Citation
    Baker AL, Lu M, Minich LL, Atz AM, Klein GL, Korsin R, Lambert L, Li JS, Mason W, Radojewski E, Vetter VL, Newburger JW; Pediatric Heart Network Investigators. Associated symptoms in the ten days before diagnosis of Kawasaki disease. J Pediatr. 2009 Apr;154(4):592-595.e2. doi: 10.1016/j.jpeds.2008.10.006. Epub 2008 Nov 28.
    Results Reference
    derived
    PubMed Identifier
    17301297
    Citation
    Newburger JW, Sleeper LA, McCrindle BW, Minich LL, Gersony W, Vetter VL, Atz AM, Li JS, Takahashi M, Baker AL, Colan SD, Mitchell PD, Klein GL, Sundel RP; Pediatric Heart Network Investigators. Randomized trial of pulsed corticosteroid therapy for primary treatment of Kawasaki disease. N Engl J Med. 2007 Feb 15;356(7):663-75. doi: 10.1056/NEJMoa061235.
    Results Reference
    derived

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    Trial of Pulse Steroid Therapy in Kawasaki Disease--Pediatric Heart Network

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