Etiology Study of Kawasaki Disease
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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:
- fever for over 5 days
- neck lymphadenopathy
- lip fissure and/or strawberry tongue
- skin rash
- nonpurulent bulbar conjunctivitis
- 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 |
- 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 |
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).
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00154596
| Contact: Luan-Yin Chang, MD, PhD | 886-2-23123456 ext 3245 | ly7077@tpts6.seed.net.tw |
| 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 | |
| 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 Cardiovascular Diseases Lymphatic Diseases Skin Diseases |
Skin Diseases, Vascular Vascular Diseases Vasculitis |
ClinicalTrials.gov processed this record on February 27, 2015