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

Cardiovascular Diseases Clinical Trial

Official title:

Trial of Pulse Steroid Therapy in Kawasaki Disease (A Trial Conducted by the Pediatric Heart Network)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00132080
• Other study ID #: 241
• Secondary ID: U01HL068270
• Status: Completed
• Phase: Phase 3
• First received: August 17, 2005
• Last updated: March 3, 2014
• Start date: December 2002
• Est. completion date: March 2005

Study information

• Verified date: April 2012
• Source: New England Research Institutes
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: March 2005
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 18 Years

Eligibility

• Fever persisting at least 4 days and the presence of at least 4 of the following 5 principal features:

1. Changes in extremities: Acute changes include erythema and edema of hands and feet; Convalescent changes include membranous desquamation of fingertips

2. Polymorphous exanthema

3. Bilateral, painless bulbar conjunctival injection without exudates

4. Changes in lips and oral cavity: Erythema and cracking of lips, strawberry tongue, diffuse injection of oral and pharyngeal mucosae

5. 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Coronary Aneurysm
• Heart Diseases
• Infection
• Mucocutaneous Lymph Node Syndrome

Intervention

Drug:
• Steroids
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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
New England Research Institutes	National Heart, Lung, and Blood Institute (NHLBI), Pediatric Heart Network

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the effect of IVMP plus IVIG to IVIG alone on coronary artery outcomes		Measured 5 weeks post-randomization	Yes
Secondary	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		Measured 5 weeks post-randomization	Yes