- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00132080
Trial of Pulse Steroid Therapy in Kawasaki Disease--Pediatric Heart Network
Trial of Pulse Steroid Therapy in Kawasaki Disease (A Trial Conducted by the Pediatric Heart Network)
Study Overview
Status
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 1
Patients with acute Kawasaki disease
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Compare the effect of IVMP plus IVIG to IVIG alone on coronary artery outcomes
Time Frame: Measured 5 weeks post-randomization
|
Measured 5 weeks post-randomization
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Measured 5 weeks post-randomization
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lynn Sleeper, ScD., New England Research Institutes, Watertown, MA
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 241
- U01HL068270 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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