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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 199 (actual)
• Sponsor: Carelon Research · Academic / Other
• Sex: All
• Age: 6 Months – 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Cardiovascular Diseases
• Heart Diseases
• Infection
• Coronary Aneurysm

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2002-12-01
• Primary completion: 2005-03-01
• Completion: 2005-03-01
• First posted: 2005-08-19
• Last updated: 2014-03-04