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Etiology Study of Kawasaki Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2005 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00154596
First received: September 9, 2005
Last updated: August 1, 2007
Last verified: June 2005
History of Changes
  Purpose

The purpose of this study is to investigate the infectious etiology of Kawasaki disease (KD); a prospective household and case control study for Kawasaki disease will be done. The investigators will enroll Kawasaki disease cases who have at least five of the following manifestations:

  1. fever for over 5 days
  2. neck lymphadenopathy
  3. lip fissure and/or strawberry tongue
  4. skin rash
  5. nonpurulent bulbar conjunctivitis
  6. palm/sole erythema and induration followed by desquamation, or coronary artery aneurysm with less than 5 of the above manifestations (atypical Kawasaki disease)

The KD cases will receive virological (virus isolation from the blood, throat swabs and rectal swabs or stool, gene chip for possible viruses from stored RNA and DNA), bacterial (blood, throat swabs and stool: bacterial culture and stored strain for further toxin or superantigen detection), and serological (Mycoplasma pneumoniae, Chlamydiae pneumoniae, ASLO, HHV6, EV71, peptide library approach for auto-antibody or pathogen-related antibody, stored serum for further workup) workup. Stored DNA from the blood will also be performed.


Condition
Kawasaki Disease

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Etiology Study of Kawasaki Disease--A Prospective Household and Case Control Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Estimated Enrollment: 100
Study Start Date: February 2004
Estimated Study Completion Date: June 2006
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   1 Month to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients who fulfill the criteria of Kawasaki disease or atypical Kawasaki disease and their household family members

Exclusion Criteria:

  • Not cases of Kawasaki disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00154596

Contacts
Contact: Luan-Yin Chang, MD, PhD 886-2-23123456 ext 3245 ly7077@tpts6.seed.net.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Luan-Yin Chang, MD, PhD     886-2-23123456 ext 3245     ly7077@tpts6.seed.net.tw    
Principal Investigator: Luan-Yin Chang, MD, PhD            
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Luan-Yin Chang, MD, PhD National Taiwan University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00154596     History of Changes
Other Study ID Numbers: 930004318
Study First Received: September 9, 2005
Last Updated: August 1, 2007
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
etiology
transmission
vasculitis
household
etiology of disease

Additional relevant MeSH terms:
Mucocutaneous Lymph Node Syndrome
Vasculitis
Vascular Diseases
Cardiovascular Diseases
 Lymphatic Diseases
Skin Diseases, Vascular
Skin Diseases

ClinicalTrials.gov processed this record on May 19, 2013