Etiology Study of Kawasaki Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00154596
First received: September 9, 2005
Last updated: August 6, 2014
Last verified: August 2014
  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: Case Control
Time Perspective: Prospective
Official Title: Etiology Study of Kawasaki Disease--A Prospective Household and Case Control Study

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Viral infections associated with Kawasaki disease [ Time Frame: 2014/3 ] [ Designated as safety issue: Yes ]
    The mean age of the 226 KD cases was 2.07 years, and the male to female ratio was 1.43 (133 boys to 93 girls). Their mean fever duration was 7.5 days with a mean peak temperature of 39.7°C. In addition to the typical symptoms of fever, neck lymphadenopathy, lip fissure and/or strawberry tongue, skin rash, nonpurulent bulbar conjunctivitis, palm/sole erythema, and induration followed by periungual desquamation, these KD cases also exhibited cough (69%), rhinorrhea (58%), and diarrhea (45%). Cases of KD had a significantly higher positive rate of viral isolation in comparison with the control group (7.5% vs. 2.2%, p = 0.02). Compared with the control group, cases of KD were more likely to have overall positive rates of viral PCR (50.4% vs. 16.4%, p < 0.001) and for various viruses including enterovirus (16.8% vs. 4.4%, p < 0.001), adenovirus (8.0% vs. 1.8%, p = 0.007), human rhinovirus (26.5% vs. 9.7%, p < 0.001), and coronavirus (7.1% vs. 0.9%, p = 0.003).


Biospecimen Retention:   Samples With DNA

Blood, throat swab, nasopharyngeal aspiration, and rectal swab will be obtained during acute illness and at convalescence (about 2 weeks after discharge). These specimens will be processed for viral isolation, bacterial culture and toxin detection, PCR, subtractive cloning, VIDISCA, gene chips, peptide library, cytokine/chemokine measurement, antibody detection for specific pathogens, etc. Questionnaire for contact history and clinical symptoms will be performed.


Estimated Enrollment: 700
Study Start Date: February 2004
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   1 Month to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

We 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 rah, 5) nonpurulent bulbar conjunctivitis, 6) palm/sole erythema and induration followed by desquamation, or cases with coronary artery aneurysm but less than 5 of the above manifestations (atypical Kawasaki disease).

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00154596     History of Changes
Other Study ID Numbers: 930004318
Study First Received: September 9, 2005
Last Updated: August 6, 2014
Health Authority: Taiwan: Ministry of Health and Welfare

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 August 28, 2014