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Prevention of Coronary Aneurysms in Kawasaki Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000520
First Posted: October 28, 1999
Last Update Posted: December 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
  Purpose
To test the efficacy of intravenous gamma globulin (IVGG) in preventing coronary artery aneurysms in children with Kawasaki Syndrome.

Condition Intervention Phase
Cardiovascular Diseases Coronary Aneurysm Heart Diseases Mucocutaneous Lymph Node Syndrome Drug: immunoglobulins, intravenous Drug: aspirin Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: July 1985
Study Completion Date: November 1989
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 mg/kg/day 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 mg/kg/day of aspirin through day 14 of illness, subsequently reduced to 3 to 5 mg/kg/day as a single daily dose or to 400 mg/kg/day 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 mg/kg of intravenous gamma globulin over four consecutive days. Two hundred and seventy-three received a single infusion of 2 g/kg of body weight over 10 hours. Both treatment groups received 100 mg/kg of aspirin per day through day 14 and then 3 to 5 mg/kg 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Boys and girls who met the CDC criteria for Kawasaki Syndrome. Subjects were excluded if they presented themselves to the participating centers after the tenth day of illness.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000520


Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
OverallOfficial: Fred Rosen Children's Hospital Medical Center, Cincinnati
  More Information

Publications:
Hicks RV, and Melish ME: Kawasaki Syndrome. In: Michael L. Miller (editor) The Pediatric Clinics of North American (Pediatric Rheumatology), pp. 1151-1175. W.B. Saunders Co., October 1986.
Melish ME, and Hicks RV. Kawasaki Syndrome. In: John D. Nelson (editor) Current Therapy in Pediatric Infectious Disease, pp. 106-162. The C.V. Mosby Co., 1986.

ClinicalTrials.gov Identifier: NCT00000520     History of Changes
Other Study ID Numbers: 39
R01HL034545 ( U.S. NIH Grant/Contract )
First Submitted: October 27, 1999
First Posted: October 28, 1999
Last Update Posted: December 13, 2013
Last Verified: April 2012

Additional relevant MeSH terms:
Syndrome
Cardiovascular Diseases
Heart Diseases
Aneurysm
Coronary Aneurysm
Mucocutaneous Lymph Node Syndrome
Disease
Pathologic Processes
Vascular Diseases
Coronary Disease
Myocardial Ischemia
Vasculitis
Lymphatic Diseases
Skin Diseases, Vascular
Skin Diseases
Immunoglobulins
Antibodies
Immunoglobulins, Intravenous
gamma-Globulins
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs