Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00132080
Status:
COMPLETED
Last Update Posted:
2014-03-04
First Post:
2005-08-17
Brief Title:
Trial of Pulse Steroid Therapy in Kawasaki Disease--Pediatric Heart Network
Sponsor:
Carelon Research
Organization:
Carelon Research
Study Overview
Official Title:
Trial of Pulse Steroid Therapy in Kawasaki Disease A Trial Conducted by the Pediatric Heart Network
Status:
COMPLETED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 gmkg 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
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 gmkg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01HL068270 | NIH | None | httpsreporternihgovquickSearchU01HL068270 |