Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000520
Status:
COMPLETED
Last Update Posted:
2013-12-13
First Post:
1999-10-27
Brief Title:
Prevention of Coronary Aneurysms in Kawasaki Syndrome
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
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:
To test the efficacy of intravenous gamma globulin IVGG in preventing coronary artery aneurysms in children with Kawasaki Syndrome
Detailed Description:
BACKGROUND
Kawasaki Syndrome is an acute febrile illness that occurs predominantly in previously healthy young children It is of unknown etiology and was first described in Japan in 1967 The illness carries an acute mortality rate of approximately 3 percent The Centers for Disease Control defines Kawasaki Syndrome as a fever lasting five or more days for which no explanation can be found Patients also must have at least four of the following symptoms bilateral conjunctival infection infected or fissured lips pharynx or a strawberry tongue erythema of the palms or soles or edema of the hands or feet or generalized or periungual desquamation rash and cervical lymphadenopathy
Coronary artery aneurysms occur in 15-20 percent of children with the illness In the past no treatment had been shown to be effective in preventing this complication Investigators in Japan began to use IVGG to reduce the aneurysm formation Preliminary results showing the usefulness of this therapy led to a multicenter trial in Japan in which 400 mgkgday of IVGG were given for five days to children also receiving aspirin for the condition Results of the Japanese trial showed that within 29 days of the onset of the disease coronary artery dilatation had developed in 42 percent of the aspirin-treated children and in 15 percent of the IVGG and aspirin-treated children
DESIGN NARRATIVE
Phase I was randomized unblinded and stratified by age sex and center Subjects were randomized to receive either 80 to 120 mgkgday of aspirin through day 14 of illness subsequently reduced to 3 to 5 mgkgday as a single daily dose or to 400 mgkgday of intravenous gamma globulin for four consecutive days plus aspirin as above Primary endpoint was formation of aneurysms as demonstrated by echocardiograms Follow-up was for 7 weeks
Phase II of the trial began enrollment of 549 patients in May 1986 and ended enrollment in November 1989 Two hundred and seventy six children were randomized to receive 400 mgkg of intravenous gamma globulin over four consecutive days Two hundred and seventy-three received a single infusion of 2 gkg of body weight over 10 hours Both treatment groups received 100 mgkg of aspirin per day through day 14 and then 3 to 5 mgkg per day The primary outcome variables were the presence or absence of coronary artery abnormalities evident at the two week and seven week follow-up examinations Echocardiograms were obtained for 523 children at the two week visit and for 520 children at the seven week visit
Kawasaki Syndrome is an acute febrile illness that occurs predominantly in previously healthy young children It is of unknown etiology and was first described in Japan in 1967 The illness carries an acute mortality rate of approximately 3 percent The Centers for Disease Control defines Kawasaki Syndrome as a fever lasting five or more days for which no explanation can be found Patients also must have at least four of the following symptoms bilateral conjunctival infection infected or fissured lips pharynx or a strawberry tongue erythema of the palms or soles or edema of the hands or feet or generalized or periungual desquamation rash and cervical lymphadenopathy
Coronary artery aneurysms occur in 15-20 percent of children with the illness In the past no treatment had been shown to be effective in preventing this complication Investigators in Japan began to use IVGG to reduce the aneurysm formation Preliminary results showing the usefulness of this therapy led to a multicenter trial in Japan in which 400 mgkgday of IVGG were given for five days to children also receiving aspirin for the condition Results of the Japanese trial showed that within 29 days of the onset of the disease coronary artery dilatation had developed in 42 percent of the aspirin-treated children and in 15 percent of the IVGG and aspirin-treated children
DESIGN NARRATIVE
Phase I was randomized unblinded and stratified by age sex and center Subjects were randomized to receive either 80 to 120 mgkgday of aspirin through day 14 of illness subsequently reduced to 3 to 5 mgkgday as a single daily dose or to 400 mgkgday of intravenous gamma globulin for four consecutive days plus aspirin as above Primary endpoint was formation of aneurysms as demonstrated by echocardiograms Follow-up was for 7 weeks
Phase II of the trial began enrollment of 549 patients in May 1986 and ended enrollment in November 1989 Two hundred and seventy six children were randomized to receive 400 mgkg of intravenous gamma globulin over four consecutive days Two hundred and seventy-three received a single infusion of 2 gkg of body weight over 10 hours Both treatment groups received 100 mgkg of aspirin per day through day 14 and then 3 to 5 mgkg per day The primary outcome variables were the presence or absence of coronary artery abnormalities evident at the two week and seven week follow-up examinations Echocardiograms were obtained for 523 children at the two week visit and for 520 children at the seven week visit
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL034545 | NIH | None | httpsreporternihgovquickSearchR01HL034545 |