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)

Status Completed

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.

Clinical Trial 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 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

• NCT number: NCT00132080
• Study type: Interventional
• Source: New England Research Institutes
• Status: Completed
• Phase: Phase 3
• Start date: December 2002
• Completion date: March 2005